Between 2002-2008, a trained examiner used a validated foot exam to document presence of hallux valgus, lesser toe deformities and plantar soft tissue atrophy in 2,446 adults from the Framingham Foot Study. Among these, 1,370 participants with available pedigree structure were included. Heritability (h²) was estimated using pedigree structures by Sequential Oligogenic Linkage Analysis Routines (SOLAR) package. Results were adjusted for age, sex and BMI.

Mean age of participants was 66 years (range 39 to 99 years) and 57% were female. Prevalence of hallux valgus, lesser toe deformities and plantar soft tissue atrophy was 31%, 29.6% and 28.4%, respectively. Significant h² was found for hallux valgus (0.29 ~ 0.89, depending on age and sex) and lesser toe deformity (0.49 ~ 0.90 depending on age and sex). The h² for lesser toe deformity in men and women aged 70+ years was 0.65 (p= 9x10^-7). Significant h² was found for plantar soft tissue atrophy in men and women aged 70+ years (h² = 0.37; p=3.8x10^-3).

To our knowledge, these are the first findings of heritability of foot disorders in humans, and they confirm the widely-held view that hallux valgus and lesser toe deformities are highly heritable in European-descent Caucasian men and women, underscoring the importance of future work to identify genetic determinants of the underlying genetic susceptibility to these common foot disorders. © 2013 by the American College of Rheumatology

The PedsQL™ Rheumatology Module is currently the only available measure of disease-specific Quality of Life (QOL) for children and adolescents with juvenile fibromyalgia (JFM) but limited information has been published about the psychometric properties of the instrument specifically in JFM. The objective of this study was to assess the reliability, validity and sensitivity to change of the 5 scales (pain and hurt, daily activities, treatment, worry and communication) of the patient and parent-proxy versions of the PedsQL™ Rheumatology Module in the context of a randomized clinical trial in JFM.

The entire PedsQL™ Rheumatology Module was administered as a supplementary outcome measure at pre-treatment, post-treatment and 6-month follow-up assessments of 114 children and adolescents with JFM enrolled in a trial testing the efficacy of cognitive-behavioral therapy (CBT).

Results indicated that internal consistency reliabilities for the scales were adequate to strong (Cronbach αs 0.68 - 0.86). Parent- proxy and child reports on most scales (except for daily activities and communication) showed moderate correlations (Spearman rs 0.33- 0.45). Support for construct validity was found based on comparing child and parent reports with other related measures of pain and functioning (Visual Analog Scale pain ratings and the Functional Disability Inventory). Finally, sensitivity to change was demonstrated by significant changes in 4/5 of the scales (excluding the daily activities scale) after treatment.

The PedsQL™ Rheumatology Module generally appears to have good utility for use in JFM patients but some caveats to interpretation of the specific scales in this population are discussed. © 2013 American College of Rheumatology.

A two-group, randomized study design was used to compare an intervention for RA vs. waiting-list control condition.The intervention used a secure website (RAHelp.org) to providea 10-week program with weekly educational modules for improving self-efficacy in self-management of RA, plus tools for group interaction.Weekly telephone contacts were made to encourage use of program tools and apply newly learned skills. Anation-wide convenience sample of 106 adult participants was recruited primarily through online advertisements. Mean age was 50 years; 93% women. Main outcome measures included the Arthritis Impact Measurement Scales-2 (AIMS-2; Affective, Physical, Role, Social, Pain, and Symptoms components); Arthritis Self-Efficacy Scale (ASES); Center for Epidemiologic Studies – Depression scale (CES-D); Quality of Life Scale (QOLS); Rapid Assessment of Disease Activity in Rheumatology (RADAR);Social Provisions Scale (SPS); and UCLA Loneliness Scale-3 (LS-3).

Group differences with large and moderate effect sizes (ES), respectively,were found immediately post-intervention for self-efficacy (ASES; p=.00001; ES=.92) and quality of life (QOLS; p=.003; ES=.66). At 9 months post-intervention, differences in self-efficacy (ASES; p=.00001; ES=.92) and quality of life (QOLS; p=.004; ES=.71) remained robust.

RAHelp appears to have beneficial effects, in terms of self-efficacy and quality of life, among individuals who have RA, who are willing to use an online service format. © 2013 by the American College of Rheumatology

Healthy 4-year-olds (n=28) completed the CMAS. Their scores were compared with children with JDM (n=18) who had a muscle Disease Activity Score (DAS-M) of zero.

The healthy children achieved a mean CMAS score of 46.6 ±2.3 and an inter-quartile range of (46,47). There were no significant differences between boys and girls; the scores were not significantly associated with height or weight. The greatest variation involved items that assessed endurance. Item 1: neck raise, yielded a mean score of 28.2 ±19.3 seconds, with a CMAS score of 2.5 ±0.9, (maximum score = 5). Item 3: leg lift, yielded a mean score of 55.5 ±37.3 seconds, with a mean CMAS score of 3.1 ±1.1, (maximum score = 5). Item 5: sit ups maneuver, yielded a mean score of 5.3 ±1.1 sit ups. Almost identical data were obtained for the 18 treated children with JDM who had normal strength on DAS-M.

Healthy children aged 4 years do not achieve the total CMAS of 52, attained by older children. Both boys and girls were remarkably consistent, with a mean CMAS of 46.6. Children with JDM, age 4 with a DAS-M of zero, also achieved a CMAS of 46.6. We conclude that half of 4-year-old children achieve a CMAS of 46 or 47, not a CMAS of 52, suggesting that weakness may be over diagnosed in 4–year-olds with an inflammatory myopathy. © 2013 by the American College of Rheumatology

A retrospective cohort study was conducted using the US insurance claims. RA and non-RA patients were matched on age, sex, and index date. Incidence rates (IR) and rate ratios (RR) of VTE, defined as the composite of deep vein thrombosis (DVT) or pulmonary embolism (PE), were calculated. Cox proportional hazards models compared VTE risks between RA and non-RA patients, adjusting for VTE risk factors such as CVD, surgery, hospitalization, medications, and acute phase reactants (APR).

Over the mean follow-up of 2 years, the IR for VTE among RA patients was 6.1 per 1,000 person-years, 2.4 times higher (95%CI 2.1-2.8) than the rate of non-RA patients. The IRs for both DVT (RR 2.2, 95%CI 1.9-2.6) and PE (RR 2.7, 95%CI 2.2-3.5) were higher in RA compared with non-RA patients. After adjusting for risk factors of VTE, the VTE risk remained elevated in RA (hazard ratio 1.4, 95%CI 1.1-1.7) compared to non-RA patients. The result was similar after further adjustment for elevated APR (hazard ratio 1.5, 95%CI 0.3-6.5). One-third of patients who developed VTE had at least one major VTE risk factors 90 days before and after the VTE event.

Our results showed an increased risk of developing VTE for RA patients compared with non-RA patients. The risk was attenuated but remained elevated even after adjusting for various risk factors for VTE. © 2013 by the American College of Rheumatology

To report our experience with the efficacy and safety of anakinra for acute gouty arthritis in medically complex hospitalized patients

We reviewed the hospital charts of 26 patients treated with anakinra for crystal-induced arthritis since 2007. Demographics, co-morbid conditions, reason for Anakinra use, response to treatment and any adverse outcomes were recorded

Twenty-six patients received 40 courses of anakinra therapy. In 67% of patients, pain improved significantly within 24 hours and complete resolution of signs and symptoms of gout occurred by day 5 in 72.5%. Seven patients receivedmultiple courses with no decrement in response with repeated treatments. Anakinra was well tolerated and no adverse outcomes were attributed to the drug. Only one patient appeared to be refractory to this form of IL-1 inhibition.

Anakinra is an effective and safe alternative treatment for acute gouty arthritis in medically complex hospitalized patients who fail or cannot undergo more conventional therapy © 2013 by the American College of Rheumatology

To define a valid criterion for treatment response as assessed by the Disease Activity Score-28 joints (DAS28) that exceeds random disease activity variations in patients with rheumatoid arthritis (RA).

We utilized anonymized datasets of RA patients from multiple rheumatology centers in Germany to identify patients with stable responses to conventional or biologic DMARD therapy (discovery cohort). To evaluate fluctuations in DAS28 scores, we subjected patients' DAS28 scores at Month 12, 18, and 24 to an analysis of variance model to establish a 95% one-sided confidence interval for normal fluctuations; this value was used to define the critical difference (DAS28-d_crit) for individual changes from baseline. The DAS28-d_crit value was then applied to analyses of therapeutic response in an adalimumab noninterventional study cohort.

The discovery cohort included 415 patients under stable treatment. Values for DAS28-d_crit were comparable regardless of age, gender, disease activity, and class of therapy (DMARDs or biologics) and fell below 1.8 in all subgroups. We thus conclude that DAS28 improvements of 1.8 or higher are outside the normal variation and represent a therapeutic response. When applied to data from the adalimumab noninterventional study (N=1874), a DAS28-d_crit response was more robust over time than a European League Against Rheumatism (EULAR) response and was more closely correlated with improved functional capacity.

Based on our data, a DAS-d_crit value of 1.8 signifies a positive individual therapeutic response that exceeds the threshold of random fluctuation. The DAS28-d_crit criterion may be useful in steering individual therapy and stratifying clinical trials. © 2013 by the American College of Rheumatology

To assess the inter-rater reliability of hip exam tests used to assess femoroacetabular impingement (FAI) among clinicians from different disciplines.

Twelve subjects were examined by nine clinicians using 12 hip tests drawn from a review of the literature and consultation with experts in hip pain and FAI. Examiners assessed both hips of each subject and were blinded to subject history. The order in which subjects were seen, the order of tests and the order of the two hips within each subject were all randomized. Inter-rater reliability (IRR) for the 10 categorical tests was summarized using overall raw agreement (ORA), positive agreement (PA) (agreement on abnormal findings) and negative agreement (NA) (agreement on normal findings). An ORA of > 0.75 was considered to indicate adequate reliability. For the two ROM outcomes, IRR was summarized using the median of the absolute difference (MAD) in measurements obtained by any two examiners on any patient. MAD reflects the “typical” difference (in degrees) between two raters.

Adequate reliability (ORA > 0.75) was achieved for 6 of the 10 hip exam tests with categorical outcomes. Positive agreement ranged from 0.35 to 0.84, while negative agreement ranged from 0.62 to 0.99. For the ROM outcomes examiners were, on average, within 5° of each other for flexion, and 7° for internal rotation.

The results provide evidence that the most common hip exam tests would likely be sufficiently reliable to allow agreement between examiners when discriminating between painful FAI and normal hips in a clinical setting. © 2013 by the American College of Rheumatology

to analyze the efficacy and safety of non-biologic immunosuppressants in the treatment of non-renal systemic lupus erythematosus (SLE).

Systematic review. We conducted a sensitive literature search in Medline, Embase, and the Cochrane Central Register of Controlled Trials up to October 2011. Selection criteria: a) population: adult patients with SLE, b) intervention: treatment with non-biologic immunosuppressant, c) comparator: placebo or active comparator, d) outcome measures assessing efficacy and/or safety. Meta-analyses, systematic reviews, clinical trials and cohort studies were included. The quality of each study was evaluated using the Jadad's scale and Oxford Levels of Evidence.

one hundred fifty-eight articles were selected for detailed review of the 2,827 initially found. Finally, 65 articles fulfilled the predetermined criteria. Overall, they were low-quality studies with only 11 randomized clinical trials (RCT). Cyclophosphamide demonstrated efficacy for neuropsychiatric SLE preventing relapses with additional steroid-sparing effect although its use was associated with cumulative damage, development of cervical intraepithelial neoplasia and ovarian failure. Other immunosuppressants (azathioprine, methotrexate, leflunomide, mycophenolate mofetil and cyclosporine A) demonstrated efficacy in reducing non-renal activity and flares with a steroid-sparing effect, although on occasions in non placebo-controlled RCTs of small number of patients.

several immunosuppressants have demonstrated their safety and efficacy in non-renal SLE. A specific drug for each particular manifestation cannot be recommended although cyclophosphamide may be kept to be used in more severe cases and methotrexate may be the first option in most cases of moderately active SLE. High-quality RCTs of a larger number of patients are needed. © 2013 by the American College of Rheumatology

The present study attempts to fill a research gap by performing the first dimensionality analysis of the Revised Fibromyalgia Impact Questionnaire (FIQR) using exploratory and confirmatory techniques. A second objective is to report on the reliability and construct validity of the FIQR in Spanish patients.

FIQR data from one sample of adult FM patients (n= 113) was analysed using Principal component analysis (PCA). Subsequently, a set of confirmatory factor analyses (CFAs) was conducted in another sample (n= 179) to analyze the goodness-of-fit of various factor models. FIQR reliability was assessed by computing Cronbach's alpha (α) and coefficient H. Construct validity was evaluated by comparing the FIQR scores of participants categorized by employment status.

According to the PCA, the FIQR structure might be described as having one global factor of functional impairment. Although subsequent CFAs confirmed that one factor accounts for the greatest proportion of common variance in the FIQR items, a confirmatory bifactor analysis indicated that the items are multidimensional due to their simultaneous significant loading on specific factors. The α value of the FIQR domains was very good (> 0.80) and the H estimate for the FIQR total score was excellent (0.93). Overall, the FIQR domains were able to distinguish between patients differing in employment status (working outside home vs. on sick leave).

Our results indicate that the Spanish version of the FIQR has a complex factor structure, excellent reliability and shows good construct validity. © 2013 by the American College of Rheumatology

Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease that significantly impairs patients' quality of life and can be life-threatening. This study aimstodescribe the experiences and perspectivesof adults living with SLE.

We conducted a systematic review andthematic synthesis ofqualitative studies that explored the experiences of adults living with SLE. We searched MEDLINE, Embase, PsycINFO, CINAHL(to November week 1 2012), Google Scholar, a thesis database and reference lists of relevant articles.

Forty-six studies involving 1385 participants were included. Five themes were identified: restricted lifestyle (including subthemes of pervasive pain, debilitating fatigue, mental deterioration, disruptive episodic symptoms, and postponing parenthood); disrupted identity (gaining diagnostic closure, prognostic uncertainty, being a burden, hopelessness, heightened self-consciousness, fearing rejection, and guilt and punishment); societal stigma and indifference (illness trivialisation, socially ostracised, and averse to differential treatment); gaining resilience (optimism, control and empowerment, being informed and involved, and valuing mutual understanding); and treatment adherence (preserving health, rapport with clinicians, negotiating medication regimens, and financial burden).

SLE has a severe and pervasive impact on patients'self-esteem and independence. Their physical and social functioning is limited and they feel anxious about their future. Patients perceive that SLE is trivialised, misunderstood and stigmatised by theirfamily, friends and physicians, which intensifies their sense of isolation. Educational, psychosocial and self-care interventions are needed to promote mental resilience, positive coping strategies, self-advocacy and capacities for social participation; and thereby achieve better treatment and health outcomes in patients with SLE. © 2013 by the American College of Rheumatology

Health administrative data can be a valuable tool for disease surveillance and research. Few studies have rigorously evaluated the accuracy of administrative databases for identifying rheumatoid arthritis (RA) patients. Our aim was to validate administrative data algorithms to identify RA patients in Ontario, Canada.

We performed a retrospective review of a random sample of 450 patients from 18 rheumatology clinics. Using rheumatologist-reported diagnosis as the reference standard, we tested and validated different combinations of physician billing, hospitalization and pharmacy data.

149 rheumatology patients were classified as having RA and 301 as not having RA based on our reference standard definition (study RA prevalence: 33%). Overall, algorithms that included physician billings had excellent sensitivity (94-100%). Specificity and positive predictive value (PPV) were modest to excellent and increased when algorithms included multiple physician claims or specialist claims. The addition of RA drugs did not significantly improve algorithm performance. The algorithm of “(1 hospitalization RA code) OR (3 physician RA claims with ≤1 by a specialist in a 2 year period)” had a sensitivity of 97%, specificity of 85%, PPV of 76% and NPV of 98%. Most RA patients (84%) had an RA diagnosis code present in the administrative data within +/- 1 year of a rheumatologist's documented diagnosis date.

We demonstrate that administrative data can be used to identify RA patients with a high degree of accuracy. RA diagnosis date and disease duration are fairly well estimated from administrative data in jurisdictions of universal health care. © 2013 by the American College of Rheumatology

Although it has been well established that fatigue is a common complaint among older adults with osteoarthritis (OA), relatively little is known about how fatigue in daily life affects physical activity. The purposes of this study were to examine the relationship between momentary fatigue and subsequent physical activity among people with OA who report clinically relevant levels of fatigue and to examine moderators of this relationship.

People with knee or hip OA and clinically relevant fatigue participated in physical performance assessments, completed questionnaires, and underwent a home monitoring period in which fatigue severity was measured 5 times per day over 5 days (N = 159). Physical activity was concurrently measured via a wrist-worn accelerometer. Multilevel modeling was used to examine the relationship of momentary fatigue and subsequent activity controlling for other factors (e.g., age, body mass index, pain, depression).

Fatigue was the strongest predictor of reduced subsequent activity. Only functional mobility (TUG) moderated the relationship between fatigue and activity. The relationship between fatigue and activity was strongest for people with high functional mobility.

Momentary fatigue is a robust and important variable associated with decreased physical activity. Further, the moderating effect of functional mobility suggests this is a factor that should be considered when intervening on fatigue. While people with better functional mobility may benefit from an activity-based treatment approach (such as learning activity pacing techniques to reduce fatigue's impact on activity), those with worse functional mobility may benefit from treatment focusing on underlying impairments. © 2013 by the American College of Rheumatology

To examine lipid profiles among statin-naive patients with rheumatoid arthritis (RA) and those without RA before and after the initiation of statins.

Information regarding lipid measures and statin use was gathered in a population-based incident cohort of patients with RA (1987 ACR criteria first met between 1/1/1988 and 1/1/2008) and in a cohort of non-RA subjects from the same underlying population. Only patients with no prior history of statin use were included.

The study included 161 patients with RA (mean age 56.3 years, 57% female) and 221 non-RA subjects (mean age 56.0 years, 66% female). Prior to the start of statins, the levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL) were lower in RA vs non-RA cohort (p<0.001 and p=0.003, respectively). The absolute and percent change in LDL after at least 90 days of statin use tended to be smaller in RA vs non-RA cohort (p=0.03 and p=0.09). After at least 90 days of statin use patients with RA were less likely to achieve therapeutic goals for LDL than the non-RA subjects (p=0.046). Increased erythrocyte sedimentation rate (ESR) at baseline (OR 0.47; 95%CI 0.26, 0.85) was associated with lower likelihood of achieving therapeutic LDL goals.

Patients with RA had lower TC and LDL levels before statin initiation and lower likelihood of achieving therapeutic LDL goals following statin use than the non-RA subjects. Some RA disease characteristics, in particular ESR at baseline, may have an adverse impact on achieving therapeutic LDL goals. © 2013 by the American College of Rheumatology

To determine the incidence rates and risk factors of cervical and trochanteric hip fractures (HF) among patients with systemic lupus erythematosus (SLE) based on a nationwide population-based dataset

We conducted a cohort study using data from the Taiwan National Health Insurance database. Patients with SLE and their age- and gender-matched counterparts without SLE were identified. The primary endpoint was the first occurrence of HF. Cox proportional hazard model was used to evaluate the respective risk factors of cervical and trochanteric HF in the lupus cohort.

Among 14,544 patients with SLE (90% females and mean age of 38.1 years) with a mean follow-up of six years, 75 developed HF (incidence rate, 8.60 per 10,000 person-years). Compared to controls, the incidence rate ratios (IRRs) for developing HF among lupus patients were 3.17 (1.92-5.39, p ≥ 0.001) for cervical HF and 1.11 (0.58–2.11, p = 0.571) for trochanteric HF. The IRRs for HF were 2.38 (1.58–3.63, p ≥ 0.001) for females and 1.06 (0.21–4.93, p = 0.922) for males. Lupus patients with cervical HF were younger than controls with cervical HF (56.7 vs. 67.8 years, p = 0.007). Multivariable Cox regression analyses showed age, use of intravenous cyclophosphamide, higher dose of steroid, and stroke were associated with cervical HF, whereas age was the only associated factor for trochanteric HF.

Patients with SLE are associated with a higher risk for cervical but not trochanteric HF and these two HFs have different risk factors. © 2013 by the American College of Rheumatology

Patients with rheumatoid arthritis (RA) have increased coronary atherosclerosis possibly related to increased prevalence of visceral adiposity, insulin resistance, and metabolic syndrome. Epicardial adipose tissue (EAT), a type of visceral fat, may contribute to cardiometabolic risk. The aim of this study was to measure EAT volume in patients with RA and determine its relationship with cardiometabolic risk markers and coronary artery calcium.

EAT volume and coronary artery calcium score were measured by non-contrast cardiac computed tomography and compared in RA patients (n=162) and controls (N=89). The relationships between EAT volume and markers of cardiometabolic risk in RA were examined with adjustment for age, race and sex.

Among RA patients,EAT volume was positively associated with IL-6 (P=0.03), triglycerides (P=0.004), hypertension (P=0.01), homeostatic model of insulin resistance (HOMA) (P<0.001), smoking history (P=0.04), and homocysteine (P=0.001) and negatively associated with HDL (P=0.005). With further adjustment for waist circumference (a measure of visceral obesity), EAT remained independently associated with triglycerides, HOMA, current smoking and homocysteine (all P<0.05). EAT volume was not associated with corticosteroid use or coronary artery calcium score. Patients with metabolic syndrome had significantly greater EAT volume (P<0.001) and each increase in metabolic syndrome criteria was associated, on average, with a 20% increase (95% CI, 14-26%) in EAT volume (P<0.001).

EAT volume is associated with metabolic syndrome and cardiometabolic risk factors including insulin resistance, triglycerides, current smoking, and homocysteine levels, but not with coronary artery calcium in RA patients. © 2013 by the American College of Rheumatology

Evaluation of known group validity, ecological validity, and test-retest reliability of four domain instruments from the Patient Reported Outcomes Measurement System (PROMIS) in osteoarthritis (OA) patients.

Recruitment of an osteoarthritis sample and a comparison general population (GP) through an Internet survey panel. Pain intensity, pain interference, physical functioning, and fatigue were assessed for 4 consecutive weeks with PROMIS short forms on a daily basis and compared with same-domain Computer Adaptive Test (CAT) instruments that use a 7-day recall. Known group validity (comparison of OA and GP), ecological validity (comparison of aggregated daily measures with CATs), and test-retest reliability were evaluated.

The recruited samples matched (age, sex, race, ethnicity) the demographic characteristics of the U.S. sample for arthritis and the 2009 Census for the GP. Compliance with repeated measurements was excellent: > 95%. Known group validity for CATs was demonstrated with large effect sizes (pain intensity: 1.42, pain interference: 1.25, and fatigue: .85). Ecological validity was also established through high correlations between aggregated daily measures and weekly CATs (≥ .86). Test-retest validity (7-day) was very good (≥ .80).

PROMIS CAT instruments demonstrated known group and ecological validity in a comparison of osteoarthritis patients with a general population sample. Adequate test-retest reliability was also observed. These data provide encouraging initial data on the utility of these PROMIS instruments for clinical and research outcomes in osteoarthritis patients. © 2013 by the American College of Rheumatology

The investigation determined the association of decreased lung function in children with Idiopathic Inflammatory Myopathy (IIM) with specific clinical parameters.

This study of 38 children, 6-23 years of age, diagnosed with definite/probable IIM, evaluated the association of Myositis Specific/Associated antibodies (MSA/MAA), duration of untreated disease at diagnosis (DUD), disease activity score for muscle (DAS-M), muscle derived enzymes [Aldolase, lactate dehydrogenase (LDH), Aspartate transaminase (AST), creatine phosphokinase (CPK)], neopterin and Von Willebrand Factor antigen, and the Childhood Myositis Assessment Scores (CMAS) with data from Pulmonary Function Testing (PFTs).

Impaired PFTs were defined as: a total lung capacity (TLC) or diffusing capacity (DLCO) of <80% predicted. The PFTs documented that 37% (14/38) of the children had either a decreased TLC or a decreased DLCO; 5% (2/38) had both. Children with a decreased TLC alone 18% (7/38) were older, both at the time of PFT and diagnosis, had anti-Jo-1 and anti Scl70 antibody, elevated levels of CPK and neopterin. Children with a decreased DLCO alone 13% (5/38), had a shorter DUD, higher DAS-M and total DAS, were positive for anti-Ro or anti-PL-12, had increased LDH, elevated levels of neopterin, and aldolase, with low CMAS scores for items 1, 3, 10, 11 and 14.

Assessment of PFTs in children with IIM should be considered, since over one third of patients were found to be impaired. The presence of MSA/MAA, an elevated serum neopterin (12.4±9.6, nl<10.5), older age at diagnosis and shorter DUD suggest the presence of potential lung pathology. © 2013 by the American College of Rheumatology

To quantify impact of etanercept on work and activity impairment in employed US patients with moderate to severe rheumatoid arthritis (RA).

This prospective, observational, longitudinal study recruited RA patients initiating etanercept (50 mg/week) between January 2009 and March 2010. The Work Productivity and Activity Impairment Questionnaire (WPAI) and domestic productivity questionnaire were administered by telephone interviews at baseline and 1, 2, 3, and 6 months after etanercept initiation. Human capital approach was used to estimate costs of work impairment. Changes in WPAI measures were analyzed using Wilcoxon signed-rank test.

RA patients (n=204) initiating etanercept were mean (SD) age of 46.6 (10.9) years and 72% were women. After 6 months, 153 patients remained on treatment (continuers) and showed significant decreases in overall work impairment (41.9% at baseline vs 25.2% at 6 months, p<0.0001), absenteeism (8.4% vs 2.3%; p=0.0001), presenteeism (38.9% vs 24.3%; p<0.0001), and activity impairment (55.7% vs 30.9%; p<0.0001) and a 76.4% reduction in work hours lost weekly due to RA (3.2 vs. 0.8; p=0.0001). Projected 12-month gain in work productivity for continuers was 284.5 hours per patient, equating to $3,233 to $22,533, depending on annual income level, which partially or completely offsets the annual cost of etanercept ($20,190). Domestic productivity improved from 41.5% at baseline to 69.6% at 6 months (p<0.0001)

In US employed, moderate to severe RA patients, etanercept led to significant reductions in overall work and activity impairment; the value of the increased work productivity partially or completely offset the cost of treatment. © 2013 by the American College of Rheumatology

To assess safety and immunogenicity of live attenuated yellow fever (YF) 17D vaccine in adults receiving systemic corticosteroid therapy.

All adult travelers on systemic corticosteroid therapy who had received the YF17D vaccine in 24 French vaccination centers were prospectively enrolled and matched with healthy controls (1:2), on age and history of past YF17D immunization. Safety was assessed in a self-administered standardized questionnaire within 10 days after immunization. YF-specific neutralizing antibody titers (NTs) were measured 6 months after vaccination in patients on corticosteroids.

Between July 2008 and February 2011, 102 vaccine recipients completed the safety study (34 on corticosteroids and 68 controls). Median age was 54.9 years (interquartile range (IQR): 45.1 to 60.3) and 45 participants had a history of previous YF17D immunization. Median time on corticosteroid therapy was 10 months (IQR: 1 to 67) and the prednisone-equivalent dose was 7 mg/day (IQR: 5 to 20). Main indications were auto-immune diseases (N=14), rheumatoid arthritis (N=9) and upper respiratory tract infections (N=8). No serious adverse event was reported; however, patients on corticosteroids reported more frequent moderate/severe local reactions than controls (12% and 2% respectively, Relative Risk (95%CI) = 8.0 (1.4 to 45.9)). All subjects on corticosteroids who were tested (N=20) had NTs greater than 10 after vaccination.

After YF17D immunization, moderate/severe local reactions may be more frequent in patients on systemic corticosteroid therapy. Immunogenicity seems satisfactory. Large-scale studies are needed to confirm these results. © 2013 by the American College of Rheumatology

To investigate the efficacy and safety of creatine supplementation in fibromyalgia patients.

A 16-week, double-blind, randomized, parallel-group, placebo-controlled trial was conducted. Fibromyalgia patients were randomly assigned to receive either creatine monohydrate or placebo in a double-blind fashion. The patients were evaluated at baseline and after 16 weeks. Muscle function, aerobic conditioning, cognitive function, quality of sleep, quality of life, kidney function, and adverse events were assessed. Muscle phosphorylcreatine content was measured through phosphorus magnetic resonance spectroscopy.

After the intervention, the creatine group presented higher muscle phosphorylcreatine content when compared with the placebo group (+80.3% vs. -2.7%, respectively; p = 0.04). Furthermore, the creatine group presented greater muscle strength than the placebo group in the leg-press and chest-press exercises (creatine: +9.8% and +1.2% vs. placebo: -0.5% and -7.2%, respectively; p = 0.02 and p = 0.002). Isometric strength was greater in the creatine group than in the placebo group (+6.4% and -3.2%, respectively, p = 0.007). However, no general changes were observed in aerobic conditioning, pain, cognitive function, quality of sleep, and quality of life. Food intake remained unaltered and no side effects were reported.

Creatine supplementation increased intramuscular phosphorylcreatine content and improved lower- and upper-body muscle function, with minor changes in other fibromyalgia features. These findings introduce creatine supplementation as a useful dietary intervention to improve muscle function in fibromyalgia patients. © 2013 by the American College of Rheumatology

To assess the efficacy of therapies in healing and preventing digital ulcers (DU) in systemic sclerosis (SSc).

MEDLINE and EMBASE databases and ACR and EULAR abstracts were searched. Randomized controlled trials (RCTs) with: 1) outcomes investigating healing or prevention of DU in SSc and 2) comparing a pharmacological therapy with placebo or an active agent were included. The pooled risk ratios (RR) using the fixed-effects model was calculated and heterogeneity was tested using the I² statistic.

Sixty studies were found; 19 were not randomized, 10 did not give DU quantitative data or no comparison of a different drug, leaving 31 RCTs with 1989 patients. Quality was 3/5 or less for 11 trials. DU were not the primary outcome in many RCTs. Phosphodiesterase type 5 (PDE5) inhibitors were significant for DU healing (RR 3.28 [95% CI 1.32,8.13]; p=0.01). Two large bosentan trials were significant for mean number of new DU (standard mean difference [SMD] -0.34 [-0.57, -0.11]; p=0.004). Oral prostacyclins were not statistically different from placebo, but IV iloprost prevented new DUs (SMD-0.77 [-1.46, -0.08]; p=0.03). Single trials for atorvastatin and vitamin E were positive in the prevention and healing of DU respectively. There were many negative trials: antiplatelet therapy, oral N-acetylcysteine, heparin, dimethyl sulfoxide, ketanserin, prazosin, prostaglandin E1, cyclofenil, quinapril, and topical nitroglycerin formulation.

Small sample sizes, few comparative trials, and heterogeneity limits the conclusions. The results suggest a role for PDE5 inhibitors in the healing of DU; bosentan and IV iloprost may prevent new DU. © 2013 by the American College of Rheumatology

To evaluate the association of baseline frequent knee bending activities with the prevalence and progression of cartilage and meniscal abnormalities over 3 years and to assess the effect of frequent knee bending on the different knee compartments with 3-Tesla MRI.

We studied 115 subjects without radiographic knee osteoarthritis (OA) but with risk factors for OA from the Osteoarthritis Initiative database. The inclusion criteria at baseline were: (1) age 45-55 years old, (2) BMI of 19-27 kg/m2, (3) Western Ontario and McMaster University pain score of zero, and (4) Kellgren and Lawrence grade<2. Knee bending activities (kneeling, squatting, stair climbing, and weight lifting) were assessed by questionnaire at the baseline clinic visit. Cartilage and meniscal abnormalities were graded using the Whole-Organ MRI Score (WORMS). Logistic regression was used to determine the association of frequent knee bending with cartilage and meniscal abnormalities.

Frequent knee bending activities were associated with an increased risk of prevalent cartilage lesions (OR 3.63, 95%CI 1.39-9.52), in particular in the patellofemoral compartment (OR 3.09, 95%CI 1.22-7.79). The increase in risk was higher in subjects involved in ≥2 knee bending activities. At 3-year follow-up, individuals reporting frequent knee bending were more likely to show progression of cartilage damage (OR 4.12, 95%CI 1.27-13.36) and meniscal abnormalities (OR 4.34, 95%CI 1.16-16.32).

Frequent knee bending activities were associated with higher prevalence of knee cartilage lesions (particularly in the patellofemoral compartment) and with an increased risk of progression of cartilage and meniscal lesions in asymptomatic middle-aged subject. © 2013 by the American College of Rheumatology

To evaluate the performances (sensitivity, specificity, positive and negative predictive values) at diagnosis and study visit of the ASAS criteria in axial spondyloarthritis in patients with for chronic back pain (CBP). Secondary objective: identifying the most contributory item to diagnosis/classify spondyloarthritis.

Multi-centre, cross-sectional study. Patients: history of CBP under 45years visiting a rheumatologist in France. Data: a) items of the different sets of criteria, checking if present at diagnosis (‘diagnosis’)/after diagnosis but at study visit (‘classification’); b) Rheumatologist diagnosis at study visit. Statistical analysis: descriptive characteristics and performances for diagnosis and classification. The diagnosis of the rheumatologist was considered as the “gold standard”.

1210 patients were eligible for our analysis. Sensitivity and Specificity for ASAS axial criteria were 0.76 and 0.94, and 0.87 and 0.92 for diagnostic and classification purposes, respectively. LR+ of the ASAS axial criteria was 13.6 and 10.30 for diagnostic and classification purposes, respectively. The most contributory items to diagnosis and classification were X-ray sacroiliitis, followed by MRI sacroiliitis for diagnosis and history of uveitis for classification.

we confirm the validity of the ASAS criteria for both diagnostic and classification purposes, in a clinical setting of patients with CBP. © 2013 by the American College of Rheumatology

To identify which gait deviations are consistently associated with knee osteoarthritis (KOA) and how these are influenced by disease severity, involved compartment and gender.

Four electronic databases and reference lists of publications were searched. Cross-sectional, observational studies comparing temporospatial, joint kinematic and joint moments between individuals with KOA and healthy controls, or between KOA subgroups, were considered for review. Only publications scoring over 50% on a modified methodology quality index were included. Due to the number of gait deviations examined, only biomechanical variables reported by ≥4 publications were further analysed. Where possible, meta-analysis was performed using effect sizes calculated from discrete variables.

Forty-two publications examining 20 variables were included. The majority of consistent gait deviations associated with KOA were exhibited by those with severe disease in the temporospatial domain. Individuals with severe KOA exhibit greater stride duration than controls (ES 1.35 [95% CI 1.03 to 1.67]) and a decrease in cadence (ES -0.75 [-1.12 to -0.39]) compared with controls. The evidence for kinematic and joint moment change is primarily limited or conflicting. There was a lack of evidence for alterations in the external knee adduction moment.

Individuals with KOA exhibit a range of gait deviations compared with controls. Despite its common usage in KOA gait studies, we did not find consistent evidence that knee adduction moment differs between those with and without KOA or between disease severity levels. Further research into the reasons for a lack of difference in many gait variables in those with knee OA is needed. © 2013 by the American College of Rheumatology

Fertility is reduced in women with rheumatoid arthritis (RA), even before diagnosis. This may be due to a diminished ovarian reserve. The current study examines serum levels of anti-Müllerian hormone (AMH), the most reliable endocrine marker for ovarian reserve, in early RA patients, and the influence of disease activity and methotrexate (MTX) use on AMH concentrations.

Serum AMH levels were measured in 72 women with recent onset RA aged 18-42 years and compared to 509 healthy women. The association between AMH and rheumatoid factor (RF), anti-cyclic citrullinated peptide (anti-CCP), erosions, C-reactive protein (CRP), disease activity (DAS28) and use of MTX were assessed.

At diagnosis, age-adjusted serum AMH levels did not differ significantly between patients and controls (p=0.254). AMH levels were not related to the presence of RF (p=0.487), anti-CCP (p=0.686) or erosions (p=0.350) and showed no significant correlation with CRP levels (r = -0.207, p=0.083) or disease activity scores (DAS28, r = 0.007, p=0.955). After six months of treatment, AMH levels in patients (n=53) were lower than at time of diagnosis (p<0.001), but did not differ from controls (p=0.741). There was no significant difference in AMH values after six months of treatment between patients who did (n=31) or did not (n=22) receive MTX (p=0.287).

AMH levels in women with early RA are comparable to healthy controls, indicating that the reduced fertility in this group is not caused by diminished ovarian reserve. AMH levels are neither affected by disease activity nor by short term MTX use. © 2013 by the American College of Rheumatology

We developed RA risk models based on validated epidemiologic factors (E), genetic risk scores (GRS), and gene-environment interactions (GEI) to identify factors that can improve accuracy and reclassification.

Models including E, GRS, GEI were developed among 317 Caucasian seropositive RA cases and 551 controls from Nurses' Health Studies (NHS) and validated in 987 Caucasian ACPA positive cases and 958 controls from the Swedish Epidemiologic Investigation of RA (EIRA), stratified by gender. Primary analyses included age, smoking, alcohol, parity, weighted GRS using 31 non-HLA alleles, 8 HLA-DRB1 alleles and HLA X smoking interaction. Expanded models included reproductive, geographic, and occupational factors, and additional GEI terms. Hierarchical models were compared for discriminative accuracy using AUC and reclassification using Integrated Discrimination Improvement (IDI) and continuous Net Reclassification Index.

Mean (SD) age of RA diagnosis was 57 in NHS and 50 in EIRA. Primary models produced an AUC of 0.716 in NHS, 0.728 in EIRA women and 0.756 in EIRA men. Expanded models produced improvements in discrimination with AUCs of 0.738 in NHS, 0.728 in EIRA women and 0.769 in EIRA men. Models including G or G + GEI improved reclassification over E models; the full E+G+GEI model provided the optimal predictive ability by IDI analyses.

We have developed comprehensive RA risk models incorporating epidemiologic and genetic factors and gene-environment interactions that have improved discriminative accuracy for RA.

We developed RA risk models based on validated environmental factors (E), genetic risk scores (GRS), and gene-environment interactions (GEI) to identify factors that can improve accuracy and reclassification.

Models including E, GRS, GEI were developed among 317 Caucasian seropositive RA cases and 551 controls from Nurses' Health Studies (NHS) and validated in 987 Caucasian ACPA positive cases and 958 controls from the Swedish Epidemiologic Investigation of RA (EIRA), stratified by gender. Primary analyses included age, smoking, alcohol, parity, weighted GRS using 31 non-HLA alleles, 8 HLA-DRB1 alleles and HLA X smoking interaction. Expanded models included reproductive, geographic, and occupational factors, and additional GEI terms. Hierarchical models were compared for discriminative accuracy using AUC and reclassification using Integrated Discrimination Improvement (IDI) and continuous Net Reclassification Index.

Mean (SD) age of RA diagnosis was 57 in NHS and 50 in EIRA. Primary models produced an AUC of 0.716 in NHS, 0.728 in EIRA women and 0.756 in EIRA men. Expanded models produced improvements in discrimination with AUCs of 0.738 in NHS, 0.728 in EIRA women and 0.769 in EIRA men. Models including G or G + GEI improved reclassification over E models; the full E+G+GEI model provided the optimal predictive ability by IDI analyses.

We have developed comprehensive RA risk models incorporating epidemiologic and genetic factors and gene-environment interactions that have improved discriminative accuracy for RA. Further work developing and assessing highly specific prediction models in prospective cohorts is still needed to inform primary RA prevention trials. © 2013 by the American College of Rheumatology

To clarify gender differences in early axial spondyloarthritis (SpA).

475 patients included in the DESIR cohort, a prospective multicenter French cohort of patients with early inflammatory back pain suggestive of SpA, and fulfilling the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA were studied. The clinical and imaging features were compared between genders and according to the “clinical” or the “imaging” arm of the ASAS criteria, using univariate and multivariate analysis.

Comparisons between the 239 men and the 236 women showed higher disease activity when measured by BASDAI and BASG, higher fatigue and functional scores in women despite less radiographic sacroiliitis and MRI inflammation of sacroiliac joints and spine. Disease activity measured by ASDAS-CRP was not different between men and women. In contrast to patients classified with the “clinical” arm, disease activity and functional scores did not differ between women and men with sacroiliitis on imaging except for the fatigue and the AS-Qol. Women with sacroiliitis had more peripheral involvement and more family history whereas HLAB27 positivity, elevated CRP and MRI inflammation of spine were associated with male gender.

Women with early axial SpA according to ASAS criteria had greater disease activity when measured by BASDAI and worse functioning despite less radiological abnormalities than men. Differences in the disease expression may be confounding factors to establish the diagnosis of SpA and to assess the disease activity in women, suggesting that the “imaging arm” is a pivotal measure in the ASAS criteria. © 2013 by the American College of Rheumatology

Western studies suggest that beverages may affect serum urate (SU) levels but data from Asian populations are scarce. We evaluated the associations between beverages and SU levels in Singapore Chinese.

The study population consisted of 483 subjects from the Singapore Chinese Health Study cohort, aged 45-74 years, recruited between 1993 and 1998. Lifestyle factors, medical histories and diet were collected through in-person interviews. SU and other biomarkers were measured from blood collected between 1994 and 1996.

Mean age was 57.6 years and 44% were men. The geometric mean of SU was 321 μmol/L (range 157-719 μmol/L). Mean SU levels increased with alcohol consumption (P for trend = 0.024). The mean SU level of daily alcohol drinkers was 42.6 μmol/L higher than that of non-drinkers. Similarly, increasing frequency of green tea intake was associated with rising SU levels. The highest mean SU level was observed in daily green tea drinkers (difference of 25.0 µmol/L) relative to non-drinkers (P for trend = 0.009). Compared to non-drinkers, daily alcohol drinkers had an almost 5-fold increase in association with hyperuricaemia [odds ratio (OR) = 4.83; 95% confidence interval (CI) = 1.10-21.23) while daily green tea drinkers had a 2-fold increase in association with hyperuricaemia (OR=2.12, 95% CI=1.03-4.36). The present study did not show elevated levels of SU in individuals who consumed black tea, coffee, fruit juice or soda.

Alcohol consumption increases SU levels. The finding that daily drinking of green tea is associated with hyperuricaemia needs validation in future studies. © 2013 by the American College of Rheumatology

Use of non-biologic disease-modifying antirheumatic drugs (nbDMARD) and/or biologic DMARDs (bDMARD) is generally recommended to improve the prognosis of patients with rheumatoid arthritis (RA). The objective of this study was to describe the changing trends in DMARD use for RA over the past two decades.

We analyzed data from an open longitudinal cohort of RA patients recruited from rheumatologists' practices in Northern California. We examined baseline demographic and clinical characteristics of the participants and their long DMARD use through annual comprehensive structured telephone interviews.

A total of 1,507 established RA patients were recruited through 5 enrollment periods between 1983 and 2009. Between 1983 and 2009, the use of any DMARD increased from 71% of all patients to 83% (p for trend <0.0001). In 2009, 43% received a bDMARD, 34% were on both nbDMARD and bDMARD, and 40% were treated with only nbDMARDs. The four most commonly used nbDMARDs in 2009 were methotrexate (49%), hydroxychloroquine (30%), leflunomide (13%) and sulfasalazine (7%). Etanercept (20%) was the most commonly used bDMARD in 2009, followed by infliximab (10%), adalimumab (9%) and abatacept (6%). Use of oral steroids was common (40%-50%) and remained similar throughout the study period.

There has been a significant increase in the use of DMARDs for RA over the past two decades. However, 15% of the individuals with a clinical diagnosis of RA were not receiving DMARDs in 2009. Future research should focus on sociodemographic and clinical factors associated with DMARD use for RA. © 2013 by the American College of Rheumatology

New classification criteria for axial spondyloarthritis (SpA) have been validated by the Assessment of SpondyloArthritis international Society (ASAS) working group. We applied these criteria to estimate prevalence of SpA in randomly selected, retrospectively reviewed medical records from representative US rheumatology practices.

Rheumatologists from 101 US practices identified at-risk patients aged 18 to 44 years with chronic back pain.Medical records were reviewed against ASAS criteria. The proportion of patients meeting ASAS criteria was compared to an estimate of the total number of at-risk patients treated at participating sites and, following weighting, was extrapolated to 5520 US rheumatology practices. US census data were used to estimate national prevalence.

In a sample of 816 randomly selected records, 514 (63%) at-risk patients (95% confidence interval 59.6–66.3%) met ASAS criteria. By applying this proportion to 1,217,097 Americans estimated at risk, 766,652 were projected to meet ASAS criteria. This projection corresponds to a national prevalence of 0.70% (0.38–1.1%), or 701 per 100,000 individuals. The prevalence estimates of AS and nonradiographic axial SpA are 0.35% (0.18–0.554%) and 0.35% (0.18–0.554%), respectively. Rheumatologists diagnosed axial SpA in 491 (60%) of those at-risk, corresponding to 0.67%(0.36–1.01%) prevalence overall. However, of 514 patients meeting ASAS criteria, 124 (24%) were undiagnosed by rheumatologists.

This is the first systematic epidemiology study of axial SpA using ASAS criteria. Better recognition of axial symptoms is needed, as rheumatologists' expert clinical diagnosesare not always in agreement with ASAS criteria. © 2013 by the American College of Rheumatology

Toevaluate the quality of the methods and reporting of published studies that validate administrative database algorithms for rheumatic diseasecase ascertainment.

We systematically searched MEDLINE,Embase and the reference lists of articles published from 1980 to 2011. We included studies that validated administrative data algorithms for rheumatic disease case ascertainment using medical record or patient-reported diagnoses as the reference standard. Each study was evaluated using published standards for the reporting and quality assessmentofdiagnostic accuracy, which informedthe development of a methodological framework to help critically appraise and guide research in this area.

Twenty-three studies met the inclusion criteria. Administrative database algorithms to identify cases were most frequently validated against diagnoses in medical records (83%).Almost two-thirds of the studies (61%) useddiagnosis codesin administrative datato identify potential cases, and then reviewed medical records to confirm the diagnoses. The remaining studies did the reverse, identifying patients using a reference standard,and then testingalgorithms to identify cases in administrative data. Manyauthors (61%)described the patient population,but few(26%) reported key measures of diagnostic accuracy (sensitivity, specificity, positive and negative predictive values). Only one-thirdof studiesreported disease prevalence in the validation study sample.

Methods used in administrative data validation studies of rheumatic diseases are highly variable.Few studies report key measures of diagnostic accuracy, despite their importance for drawing conclusions about the validity of administrative database algorithms. We developeda methodological framework and recommendationsfor validation study conduct and reporting. © 2013 by the American College of Rheumatology

Autoantibodies against melanoma differentiation-associated protein 5 (MDA5) have been described in several Asian dermatomyositis (DM) cohorts, often associated with amyopathic DM and rapidly progressive interstitial lung disease (ILD). A recent study of a DM cohort seen at a US dermatology clinic reports that MDA5 autoantibodies are associated with a unique cutaneous phenotype. Given the widening spectrum of clinical findings, we evaluated the clinical features of anti-MDA5-positive patients seen at a US myositis referral center.

160 DM patients were screened for MDA5 autoantibodies by immunoprecipitation and antibody titers were analyzed in longitudinal serum samples. Anti-MDA5 positive patients were evaluated for the presence of additional myositis autoantibodies. Patient clinical characteristics were compared by retrospective chart review.

MDA5 was targeted in 11/160 (6.9%) patients with DM. Of these, nine presented with a symmetric polyarthropathy, six demonstrated overt clinical myopathy and eight had ILD. Eight anti-MDA5-positive patients exhibited the clinical attributes of the antisynthetase syndrome in the absence of Jo-1 or other anti-synthetase autoantibodies. MDA5 autoantibody titers did not correlate with clinical course.

MDA5 autoantibodies are found in DM patients presenting with a symmetric polyarthritis, clinically similar to rheumatoid arthritis. These patients often have features of the antisynthetase syndrome, but in the absence of antisynthetase autoantibodies. Most anti-MDA5 positive patients had overt clinical myopathy and ILD. The latter, while occasionally severe, typically resolved with immunosuppressive therapy. In this cohort, the MDA5 phenotype is frequently a clinical mimic of the antisynthetase syndrome and is not associated with rapidly progressive ILD. © 2013 by the American College of Rheumatology

The EULAR Sjogren's syndrome (SS) Disease Activity Index (ESSDAI) and the EULAR SS Patient reported Index (ESSPRI) were recently developed.

To determine if patients' symptoms differed between patients with and without systemic involvement and if the disease-specific indexes correlated with each other in primary SS.

15 French centers included 395 pSS patients in the ASSESS cohort. At enrollment, Physicians completed ESSDAI, SS disease activity index (SSDAI), Sjögren's Systemic Clinical Activity Index (SCAI) and patients completed ESSPRI, Sicca Symptoms Inventory (SSI), and Profile of Fatigue and Discomfort (PROFAD). All scores were compared between patients with and without systemic involvement. Correlations between scores of systemic activity and patients' symptoms were obtained.

At enrollment, 120 (30.4%) had never experienced systemic complication, 155 (39.2%) and 120 (30.4%) had, respectively, only past or current systemic manifestations. Past or current systemic patients had higher levels of symptoms except dryness. ESSDAI did not correlate with patient score ESSPRI (rho=0.06; p=0.30), whereas the SSDAI and SCAI, that include subjective items, did (rho=0.28 and 0.25 respectively ; p<0.0001 for both).

Alterations of common patient reported outcomes are present in all patients with pSS including those with systemic complications. However, patient's symptoms and systemic complications are 2 different faces of pSS. Therefore, the use of both systemic and patients indexes, such as ESSDAI and ESSPRI, are useful. Since these 2 faces weakly overlap, when designing clinical trials in pSS, one should identify which of both components is the main target of the treatment to test. © 2013 by the American College of Rheumatology

Immunosuppressive therapy may trigger hepatitis B virus (HBV) reactivation, for increased morbidity and mortality. We aimed to describe HBV reactivation in patients receiving treatment for immune-mediated inflammatory diseases (IMID) and to evaluate a predefined algorithm for its prevention.

Physicians submitted data for patients receiving treatment for IMID and exhibiting HBV reactivation, defined as an increase >1 log10 IU/mL of HBV DNA levels or DNA reappearance. We systematically reviewed cases in the literature.

The 35 physician-collected patients had rheumatoid arthritis (n=14), connective tissue disease (n=7), vasculitis (n=5) and other diseases (n=9). At baseline, 65.7% patients were positive for HB surface antigen (HbsAg+), 31.4% had a history of HBV infection, and 2.9% had occult HBV infection. Reactivation occurred 35 (2–397) weeks after the start of corticosteroid and/or immunosuppressive therapy. In all, 88.6% of patients were clinically asymptomatic, but 25.7% had severe hepatitis; none had fulminant hepatitis. Management was antiviral therapy for 91.4%, with discontinuation or decrease of immunosuppressive therapy for 45.7%. In pooling these 35 cases and 103 from the literature, 73.9% patients were clinically asymptomatic, 33.3% had severe hepatitis and 12.3% died and/or had fulminant hepatitis. Reactivation occurred early with rituximab or cyclophosphamide therapy and in HBsAg+/HBV DNA+ patients. Using the predefined algorithm, 78% of patients with reactivation would have received preemptive antiviral therapy.

We provide new insights into HBV reactivation in patients receiving treatment for IMID. A predefined algorithm may be effective in reducing the risk of HBV reactivation in this population. © 2013 by the American College of Rheumatology

To investigate the association between potential risk factors and falls in community dwelling adults with rheumatoid arthritis (RA).

1 year follow-up in a prospective cohort study with monthly falls calendars and telephone calls. Lower limb muscle strength, postural stability, number of swollen and tender joints, functional status, history of falling, fear of falling, pain, fatigue, medication and use of steroids were assessed as risk factors for falls.

386 women and 173 menwith RA, aged 18–88 (n=559) completed baseline. 535 participants (96%) completed 1 year follow-up. Bivariate logistic regression showed that falls risk was not associated with age or gender. Multivariate logistic regression revealed that a history of multiple falls in the previous 12 months was the most significant predictive risk factor (OR=5.3, 95% CI 2.3 to 12.3). The most significant modifiable risk factors were swollen and tender lower limb joints (OR=1.7, 95% CI 1.1 to 2.7), psychotropic medication (OR=1.8, 95% CI 1.1 to 3.1) and fatigue (OR=1.13,95% CI 1.02 to 1.2).

Adults with RA are at high risk of falls. In clinical practice high risk falls patients with RA can be identified by asking whether patients have fallen in the past year. Important risk factors highlighted in this study included: swollen and tender lower limb joints; fatigue and use of psychotropic medicines. © 2013 by the American College of Rheumatology

Pulmonary disease represents an important extra-articular manifestation of rheumatoid arthritis (RA). While the association of RA and interstitial lung disease is widely acknowledged, obstructive lung disease (OLD) in RA is less well understood. We therefore aimed to assess incidence, risk factors and mortality of OLD in patients with RA.

We examined a population-based incident cohort of patients with RA and a comparison cohort of individuals without RA. OLD was defined using a strict composite criterion. Cox-proportional hazards models were used to compare OLD incidence between the RA and comparator cohort, to investigate risk factors and to explore the impact of OLD on patient survival.

594 patients with RA and 596 subjects without RA were followed for a mean of 16.3 and 19.4 years, respectively. The lifetime risk of developing OLD was 9.6% for RA patients and 6.2% for subjects without RA; hazard ratio (HR) 1.54 (95% CI 1.01 to 2.34). The risk of developing OLD was higher among male patients, current or former smokers and for individuals with more severe RA. Survival of RA patients diagnosed with OLD was worse compared to those without OLD (HR 2.09, 95% CI 1.47 to 2.97).

Patients with RA are at higher risk of developing OLD, which is significantly associated with premature mortality. Effective diagnostic and therapeutic strategies to detect and manage OLD in patients with RA may help to improve survivorship in these patients. © 2013 by the American College of Rheumatology

To assess the utility of anti-MDA5 antibody measurement for predicting a risk for developing rapidly progressive interstitial lung disease (RP-ILD) in patients with polymyositis/dermatomyositis (PM/DM).

A single-center cohort of 64 consecutive Chinese patients with PM/DM was examined. Serum anti-MDA5 antibody was measured by enzyme-linked immunosorbent assay. For meta-analysis, we searched PubMed and Institute for Scientific Information Web of Knowledge (ISI WoK) for original studies that measured anti-MDA5 antibodies in patients with PM/DM. We calculated pooled sensitivity, specificity, diagnostic odds ratio (DOR), and the summary receiver operating characteristic (sROC) curve.

In Chinese patients, anti-MDA5 antibodies were detected in 26 patients with classic DM or clinically amyopathic DM (CADM). Compared with anti-MDA5-negative patients, anti-MDA5-positive patients showed a higher prevalence of RP-ILD (P = 0.001). In a total of 233 patients with anti-MDA5 antibody, derived from 16 studies, a higher frequency of CADM was found in Japanese than in non-Japanese patients (74.7% vs. 39.2%, P = 1.2×10^-7). Meta-analysis revealed that the pooled sensitivity and specificity of anti-MDA5 antibody for RP-ILD were 77% (95% CI 64-87%) and 86% (95% CI 79-90%), respectively. The pooled diagnostic OR was 20.41 (95% CI 9.02-46.20) with a favorable area under the sROC curve 0.89 (95% CI 0.63-0.98).

Detection of anti-MDA5 antibody is a valuable tool for identifying DM patients with a high risk for developing RP-ILD, but the distribution of classic DM and CADM in patients with this antibody varies among ethnic groups. © 2013 by the American College of Rheumatology

Treatment to target (T2T) leads to improved clinical outcomes in early rheumatoid arthritis (RA). The question is whether these results sustain in the long-term. The objective was to investigate the three year results of a protocolized T2T strategy in daily clinical practice.

In the Dutch Rheumatoid Arthritis Monitoring remission induction cohort, patients newly diagnosed with RA were treated according to a T2T strategy aiming at remission (Disease Activity Score in 28 joints (DAS28) < 2.6). Patients were treated with methotrexate, followed by the addition of sulfasalazine, and exchange of sulfasalazine with anti-tumor necrosis factor α agents in case of failure. Primary outcomes were disease activity, Health Assessment Questionnaire (HAQ) score, SF-36 physical and mental component summary (PCS and MCS, respectively) scores, and the Sharp/van der Heijde (SHS) score after three years. Secondary outcomes were sustained DAS28 remission (= six months) and remission according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition.

After three years (n=342), 61.7% of patients were in DAS28 remission and 25.3% met the provisional ACR/EULAR definition of remission. Sustained remission was experienced by 70.5%, which in the majority was achieved with conventional disease-modifying antirheumatic drugs only. The median (interquartile range) scores were as follows; HAQ, 0.4 (0.0-1.0); PCS, 45.0 (38.4-53.2); MCS, 53.1 (43.2-60.8); and total SHS, 6.0 (3.0-13.0).

In very early RA, T2T leads to high (sustained) remission rates, improved physical function and health-related quality of life, and limited radiographic damage after three years in daily clinical practice. © 2013 by the American College of Rheumatology

To assess the association between high body mass index (BMI) and treatment response in recent onset RA.

In the BeSt study, 508 patients were randomized to initial monotherapy or combination therapy with prednisone or infliximab (IFX). Response to disease activity score (DAS)≤2.4 steered treatment (first dose and after 1 year) was compared between patients with a BMI <25 and ≥25, using relative risk regression analyses. DAS, components of DAS and functional ability during the first year were compared using linear mixed models.

High BMI was independently associated with failure to achieve DAS≤2.4 on initial therapy, RR 1.20 (1.05-1.37). The effect for combination therapy with prednisone was RR 1.55 (1.06-2.28) and for combination therapy with IFX 1.42 (0.98-2.06). The RRs for failure after one year were 1.46 (0.75-2.83) and 2.20 (0.99-4.92) respectively. High BMI was also associated with failure on delayed combination therapy with IFX, after adjustment for selection bias related to previous failure on DMARDs. No significant association was observed in the initial monotherapy groups. In the first year, patients with a high BMI had higher DAS and worse functional ability, with more tender joints and a higher VAS global health, but not more swollen joints and similar systemic inflammation.

High BMI was independently associated with failure to achieve low DAS on initial combination therapy with prednisone and on initial and delayed treatment with infliximab. Patients with a high BMI experienced more pain, but not more swelling or systemic inflammation. © 2013 by the American College of Rheumatology

Pregnancyoutcomes of patients with vasculitis are unknown but are of great concern to patients and physicians.Through an online survey, this study assessed pregnancy outcomes among patients with vasculitis.

Participants in the Vasculitis Clinical Research Consortium Patient Contact Registry were invited to respond to ananonymous, Internet-based survey that included questions about pregnancy outcomes, the timing of pregnancy relative to a diagnosis of vasculitis, and medication use.

350 women and 113 mencompleted the survey.74 pregnancies after a diagnosis of vasculitis were reported by women and 18 by men.The rate of pregnancy loss was higher among women who conceived after the diagnosis of vasculitis compared to those who conceived prior to vasculitis (33.8% vs. 22.4%, p=0.04).Among women, the rate of preterm births increased significantly for pregnancies conceived after vasculitis relative to those conceived before (23.3% vs. 11.4%, p=0.03).Only 18% of women reported worsening of vasculitis during pregnancy, but those who experienced increased vasculitis activity were more likely to deliver preterm.Exposure to cyclophosphamide or prednisone did not appear to impact pregnancy outcomes; however, the numbers of pregnancies among women taking these medicationswas small. Among the pregnancies conceived by men with vasculitis, the timing of diagnosis had no significant effect on the rate of pregnancy loss.

Women who conceivedafter the diagnosis of vasculitis had a higher rate of pregnancy loss thandid those who conceived prior to diagnosis.Vasculitis did not worsen during the majority of pregnancies conceived after diagnosis. © 2013 by the American College of Rheumatology

To determine agreement among the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria, a diagnosis of rheumatoid arthritis (RA) by a rheumatologist, and other criteria previously used to classify arthritis.

We used the nationwide, longitudinal, prospective cohort (ESPOIR) of patients with recent-onset arthritis. After 2 years, patients were classified based on disease-modifying antirheumatic drug (DMARD) treatment; synovitis; erosions typical of RA; rheumatologist diagnosis of RA with > 50.0% certainty, no better alternative diagnosis with > 50.0% certainty; 1987 ACR criteria; and 2010 ACR/EULAR criteria. Agreement among these criteria was assessed based on Cohen's kappa coefficient, as follows: excellent, 0.80; good, 0.60-0.79; moderate, 0.40-0.59; and poor, < 0.40).

Of the 692 evaluated patients, 544 (78.6%) had persistent arthritis (defined as synovitis, ongoing DMARD treatment, or both) after 2 years. Among them, 496 (91.2%) were receiving DMARDs. Agreement among all criteria was poor (estimated kappa 0.09–0.32) except when including rheumatologist diagnosis of RA with > 50.0% certainty or no better alternative diagnosis with > 50.0% certainty (estimated kappa, 0.69-0.81). The strongest associations with rheumatologist diagnosis with > 50.0% certainty were for the 2010 ACR/EULAR criteria set and the combination of no better alternative diagnosis, persistent arthritis, 1987 ACR criteria, and positive anti-citrullinated peptide antibody.

Rheumatologist diagnosis of RA with > 50.0% certainty after 2 years agrees well with 2010 ACR/EULAR criteria or a combination of items including no better alternative diagnosis, confirming their high value as classification criteria after 2 years of follow up. © 2013 by the American College of Rheumatology

To evaluate the relationship between long-term maintenance of moderate-vigorous physical activity (MVPA) and clinical outcomes in fibromyalgia (FM).

Patients with FM (n=170) received individualized exercise prescriptions and completed baseline and follow-up physical activity assessments using the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire at weeks 12, 24, and 36. The primary outcome was the change in the Fibromyalgia Impact Questionnaire-Physical Impairment (FIQ-PI) score. Secondary outcomes included improvements in overall well-being (FIQ-Total), pain severity ratings, and depression.

Using a threshold increase in MVPA of ≥10 metabolic equivalent hours per week (MET h/wk) above usual activities, 27 subjects (15.9%) increased and sustained (SUS-PA), 68 (40%) increased, but then declined (UNSUS-PA), and 75 (44.1%) did not achieve this benchmark (LO-PA). Compared to LO-PA subjects, both SUS-PA and UNSUS-PA subjects reported greater improvement in FIQ-PI (p<0.01) and FIQ-Total (p<0.05). Additionally, the SUS-PA group reported greater improvement in pain severity compared to the LO-PA group (p<0.05). However, there were no significant group differences between SUS-PA and UNSUS-PA for any primary or secondary outcome measure.

Increased participation in MVPA for at least 12 weeks improves physical function and overall well-being in patients with FM. Although sustained physical activity was not associated with greater clinical benefit compared to unsustained physical activity, these findings also suggest that performing greater volumes of physical activity is not associated with worsening pain in FM. Future research is needed to determine the relationship between sustained MVPA participation and subsequent improvement in patient outcomes.

The aim of this study was to determine the population prevalence of joint hypermobility (JH) and to test the hypothesis that JH would be associated with reporting musculoskeletal pain.

We conducted a cross-sectional population survey in Aberdeen city and Cheshire. 45949 questionnaires were mailed which assessed JH and the presence, distribution, duration and severity of musculoskeletal pain. Based on their pain reports, participants were classified as having chronic widespread pain (CWP), some pain, or no pain. Multinominal logistic regression tested the relationship between JH and pain status. Associations were adjusted for age, sex and other putative confounders. Participants with no pain were the referent category. Results are presented as relative risk ratios (RRR), 95% confidence intervals (CI).

12,853 (29.3%) participants returned a questionnaire with complete data. 2,354 (18.3%) participants were classified as hypermobile. 2,094 participants (16.3%) had CWP and 5,801 (45.1%) had some pain and 4,958 participants (38.6%) reported no pain. JH participants were significantly more likely to report CWP than non-JH participants (18.5% vs. 15.8%, p<0.001). After adjusting for age and sex, hypermobile participants were 40% more likely to report the most severe CWP (1.4 (1.1-1.7), p<0.00). After further adjustments for employment status, smoking, alcohol and physical activity, JH remained significantly associated with the most severe CWP (1.6 (1.3-2.1), p<0.000) and some pain (1.3 (1.02-1.6), p=0.03).

JH was associated with severe pain; however this relationship was not specific to CWP. The relationship was relatively modest and may be explained by unmeasured confounding factors such as psychological distress. © 2013 by the American College of Rheumatology

To examine arthritis impact among U.S. adults with self-reported, doctor-diagnosed arthritis using the International Classification of Functioning, Disability, and Health (ICF) framework (domains=Impairments, Activity Limitations, Environmental, and Personal factors; outcome=social participation restriction (SPR)) 1) overall and among those with SPR, and 2) to identify correlates of SPR.

Cross-sectional 2009 National Health Interview Survey data were analyzed to examine the distribution of ICF domain components. Unadjusted and multivariable-adjusted prevalence ratios (PR) and 95% confidence intervals (CI) were estimated to identify correlates of SPR. Analyses in SAS v9.2 survey procedures accounted for the complex sample design.

SPR prevalence was 11% (5.7 million) of adults with arthritis. After initial multivariable adjustment by ICF domain, Serious Psychological Distress (Impairments) (PR=2.5, 95% CI=2.0-3.2, ≥5 medical office visits (Environmental) (PR=3.4, 95% CI=2.5-4.4), and physical inactivity (Personal) (PR=4.8, 95% CI=3.6=6.4) were most strongly associated with SPR. A combined measure, Key Limitations (walking, standing, or carrying) (PR=31.2 (22.3-43.5) represented the Activity Limitations domain. After final multivariable adjustment incorporating all ICF domains simultaneously, the strongest associations with SPR were Key Limitations (PR= 24.3 (16.8-35.1), ≥9 hours sleep (PR=1.6, 95% CI=1.3-2.0), and income-to-poverty ratio <2.00 and severe joint pain (PR=1.4, 95% CI=1.2-1.6 for both).

SPR affects 1-in-9 adults with arthritis. This work is the first to use the ICF framework in a population-based sample to identify specific functional activities, pain, sleep, and other areas for priority intervention to reduce negative arthritis impacts, including SPR. Increased use of existing clinical and public health interventions is warranted. © 2013 by the American College of Rheumatology

The purpose of this study was to develop and test a new instrument for patient self-reported quality of osteoarthritis (OA) care, and to provide quality indicator (QI) pass rates in a Norwegian OA cohort.

The OsteoArthritis Quality Indicator (OA-QI) questionnaire was developed using published QIs, expert panels, and patient interviews. Self-reported data were collected from 359 persons in a Norwegian OA cohort, and test-retest reliability and validity were assessed. Separate QI pass rates and summary QI pass rates were calculated.

The 17-item questionnaire includes QIs related to patient education and information, regular provider assessments, referrals and pharmacological treatment. The patient self-reported questionnaire was completed with minimal respondent burden. Support for content validity was confirmed by two patient research partners and two expert panels. All ten predefined hypotheses relating to construct validity were confirmed. Test-retest Kappa coefficients ranged from 0.20-0.80 and the percent of exact agreement from 62% to 90%. The mean pass rate for individual QIs was 31% (range: 5 - 49%). Median summary QI pass rate was 27% (IQR 12 - 50%) with lower summary pass rates for non-pharmacological compared to pharmacological treatments.

To our knowledge this is the first instrument developed to measure patient-reported QI pass rates for OA care. This study indicates that the OA-QI questionnaire is acceptable to persons with OA, and its short format makes it suitable for population surveys. The low patient self-reported QI pass rates in this study suggest a potential for quality improvement in OA care. © 2013 by the American College of Rheumatology

Environmental factors may play a role in the development of rheumatoid arthritis (RA), and we have previously observed increased RA risk among women living closer to major roads (a source of air pollution). We examined whether long-term exposures to specific air pollutants were associated with RA risk among women in the Nurses' Health Study.

The Nurses' Health Study (NHS) is a large cohort of U.S. female nurses followed prospectively every two years since 1976. We studied 111,425 NHS participants with information on air pollution exposures as well as data concerning other lifestyle and behavioral exposures and disease outcomes. Outdoor levels of different size fractions of particulate matter (PM₁₀ and PM_2.5) and gaseous pollutants (SO₂ and NO₂) were predicted for all available residential addresses using monitoring data from the USEPA. We examined the association of time-varying exposures, 6 and 10 years before each questionnaire cycle, and cumulative average exposure with the risks of RA, seronegative (rheumatoid factor [RF] and anti–citrullinated peptide antibodies [ACPA]) RA, and seropositive RA.

Over the 3,019,424 years of follow-up, 858 incident RA cases were validated by medical record review by two board-certified rheumatologists. Overall, we found no evidence of increased risks of RA, seronegative or seropositive RA, with exposure to the different pollutants, and little evidence of effect modification by socioeconomic status or smoking status, geographic region, or calendar period.

In this group of socioeconomically-advantaged middle-aged and elderly women, adult exposures to air pollution were not associated with an increased RA risk. © 2013 by the American College of Rheumatology

Compelling evidence suggests that socioeconomic status (SES) is a determinant of health outcomes among persons with arthritis. SES in early-life has likewise been associated with various aspects of health, but the connection between childhood SES and health among people with arthritis remains to be investigated. The purpose of this study is to determine the influences of current and childhood SES on self-reported disability, depression, and physical and mental health among people with self-reported doctor-diagnosed arthritis.

Data originated from a North Carolinian network of primary care centers. Participants with self-reported arthritis with complete sociodemographic and relevant health information were retained in our sample (n = 782). We created summary measuresfor current and childhood SES from indicators of education, occupation and homeownership, using parental SES as a proxy for participants' childhood SES. Linear regression models were used to assess the associations between health outcomes and SES variables separately and together, adjusting for key covariates.

Lower childhood and current SES scores were associated with worse disability and physical health. Current SES was furthermore associated with mental health and depressive symptoms. Associations of low current and childhood SES with health outcomes remained significant when concurrently included in a linear model.

Childhood and current SES are both determinants of health among persons with arthritis. This underscores the importance of childhood SES as a determinant of adult health among individuals with arthritis.Further studies should focus on these associations in different populations and across different types of arthritis. © 2013 by the American College of Rheumatology

To investigate the effect of patient gender on patient-physician communication in the process of recommendation for total knee arthroplasty (TKA).

Seventy-one physicians (38 family physicians and 33 orthopaedic surgeons) in Ontario performed blinded assessments of two standardized patients (one man and one woman) with moderate knee osteoarthritis and otherwise identical scenarios. Four surgeons did not consent to including their data. Standardized patients and accompanying mock family members recorded elements of informed decision making (IDM) present/absent in the patient-physician discussion and rated physicians' interpersonal skills.

Overall, the completeness of informed decision making was low but lower still for the woman. Only 57% (38/67) and 15% (10/67) of physicians discussed the nature of the decision and elicited the patients' preference, while consulting the man and woman, respectively. Even after adjusting for physicians' recommendations regarding TKA, physicians when interacting with the woman, included fewer IDM elements (adjusted mean difference in IDM score, 1.2; 95% CI 0.6-1.8; P<0.001) and had poorer interpersonal skills (adjusted mean difference, 14.1; 95% CI 9.0-19.2; P<0.001) compared with their consultation with the man.

Physicians provided less medical information and less encouragement to participate in the decision to undergo TKA to a woman compared with a man, irrespective of their recommendation regarding TKA. Our findings suggest that in addition to directly influencing physicians' clinical decision making, gender bias may also influence physicians' interpersonal behaviour. © 2013 by the American College of Rheumatology

There are no identified clinical markers that reliably predict long-term progression of interstitial lung disease (ILD) in systemic sclerosis (SSc). Elevated C-reactive protein(CRP) levels have been reported in SSc patients. We examined the predictive significance of CRP forlong-term ILDprogression in a large early SSc cohort.

First, the CRP levels were compared between baseline samples of 266 SSc patients enrolled in the GENISOS cohort and97 unaffected matched controls. Subsequently, the correlation between CRP levels and concomitantly obtained markers of disease severity was assessed.Serially obtained % predicted forced vital capacity (FVC) was used to examine the long-term ILD progression. The predictive significance of CRP was investigated by a joint analysis of longitudinal measurements (serial FVCs up to 13 years) and survival data. This approach allowed inclusion of all 1,016 FVC measurements and accounted for survival dependency.

We confirmed that baseline CRP levels were higher in SScpatients than controls. CRP levels were associated with absence of anti-centromere antibodiesand correlated with the concomitant severity of lung, skin and joint involvement. More importantly, higher baseline CRP levels were associated with shorter survival (p<0.001) and predicted the long-term decline in FVCindependent of potential confounders (age at baseline, gender, ethnicity, disease type, current smoking,body mass index, topoisomerase status, and treatment with immunosuppressive agents) in the multivariable model (p=0.006).

Baseline CRP levels are predictive of long-term ILD progression. CRP might aid clinicians in identifying patients that require more intensive monitoring and treatment. © 2013 by the American College of Rheumatology

To compare cross-sectional and longitudinal side-differences in thigh muscle anatomical cross-sectional areas (ACSAs), strength, and specific strength (strength/ACSA) between knees with painful early vs. painful advanced radiographic osteoarthritis in the same person.

44 of2678 Osteoarthritis Initiativeparticipants (31 women; 13 men) met inclusion criteria of bilateral frequent knee pain, medial joint space narrowing (mJSN) in one knee, and no medial (or lateral) JSN in the contralateral knee. Thigh muscle ACSAs of the quadriceps, hamstrings, adductors, and individual quadriceps heads at consistent locations were determined using MRI. Isometric muscle strength was determined in extension/flexion (Good Strength Chair, MetiturOy, Finland). Baseline quadriceps ACSA and strength were considered primary, and longitudinal changes of these secondary endpoints (paired t-tests).

No significant side-differences in quadriceps (or other thigh muscles) ACSAs, strength, or specific strength were observed between mJSN vs. no-JSN knees, nor between specific mJSN strata and contra-lateral no-JSN knees, neither in men nor women. Two-year longitudinal changes in thigh muscle ACSA, and strength were small (≤5.2%) and did not differ significantly between mJSN and no-JSN knees.

In the context of previous findings that side differences in pain are associated with side differences in quadriceps ACSAs, the current results suggest that quadriceps (and other thigh muscle) properties are not independently associated with radiographic disease status (JSN), once knees have reached frequent pain status. Further, our longitudinal findings indicate that a more advanced radiographic stage of knee osteoarthritis is not necessarily associated with a longitudinal decline in muscle function. © 2013 by the American College of Rheumatology

To examine the association between smoking and cutaneous involvement in SLE.

We analyzed data from a multicenter Canadian SLE cohort. Muco-cutaneous involvement was recorded at most recent visit, using the SLEDAI-2K (rash, alopecia, oral ulcers), the SLICC/ACR Damage Index (SDI; alopecia, extensive scarring and skin ulceration) and the ACR criteria (malar rash, discoïd rash, photosensitivity, mucosal involvement). Multivariate logistic regression models were used to estimate independent association between muco-cutaneous involvement and cigarette smoking, age, sex, lupus duration, medications, and laboratory data.

In our cohort of 1346 patients, 91.0% were female, with mean age 47.1 years (standard deviation, SD 14.3) and mean disease duration of 13.2 years (SD 10.0). A total of 41.2% reported ever smoking, 14.0% were current smokers and 27.1% were past smokers. Active cutaneous manifestations occurred in 28.4%; cutaneous damage occurred in 15.4%. Regarding ACR criteria, malar rash was noted in 59.5%, discoid rash in 16.9%, and photosensitivity in 55.7%. In multivariate analysis, current smoking was associated with active SLE rash (OR 1.63; 95% CI 1.07-2.48). Having ever smoked was associated with the ACR criteria discoid rash (2.36; 1.69-3.29) and photosensitivity (1.47; 1.11-1.95), and with the total cutaneous ACR score (1.50; 1.22-1.85). We did not detect associations between previous smoking and active cutaneous manifestations. No association was found between smoking and cutaneous damage or mucosal ulcers. No interaction was seen between smoking and antimalarials.

Current smoking is associated with active SLE rash, and ever smoking with cutaneous ACR criteria. This provides additional motivation for smoking cessation in SLE. © 2013 by the American College of Rheumatology

Palpable tendon friction rubs (TFRs) in systemic sclerosis (SSc) have been associated with diffuse cutaneous skin disease, increased disability and poor survival. Our objective was to quantify the prognostic implications of palpable TFRs on the development of disease complications and longer-term mortality in an incident cohort of early diffuse SSc patients.

We identified early diffuse SSc patients (disease duration < 2 years from the first SSc symptom) first evaluated at the Pittsburgh Scleroderma Center between 1980-2006 and found to have palpable TFRs. These were matched 1:1 with the next consecutive early diffuse SSc patient without TFR as a control. All had two or more clinic visits and five years of follow-up from the first visit.

287 early diffuse SSc patients with TFR were identified and matched to 287 controls. The mean disease duration was 0.82 years in TFR patients and 1.04 years in controls. Mean follow-up was 10.1 years in TFR patients, and 7.9 years in controls. Over the course of their illness, patients with TFR had a greater than two-fold risk of developing renal crisis, cardiac and gastrointestinal disease complications, even after adjustment for other known factors. Patients with TFR had poorer five and ten year survival rates.

Patients with early diffuse SSc having one or more TFRs are at increased risk of developing renal, cardiac and gastrointestinal involvement before and after their first Scleroderma Center visit, and have reduced survival. Patients presenting with TFRs should be carefully monitored for serious internal organ involvement.

To conduct a systematic review of the literature on the validation of algorithms identifying infections in administrative data for future use in populations with rheumatic diseases.

Medline and Embase were searched using the themes “administrative data” and “infection”, between 1950 to October 2012. Inclusion criteria: validation studies of administrative data identifying infections in adult populations. Article quality was assessed using a validated tool.

5941 articles were identified, 90 articles underwent detailed review and 24 studies were included. The majority (17/24) examined bacterial infections and nine examined opportunistic infections. Eighteen studies were from the United States and all but four studies used ICD-9 codes. Rheumatoid arthritis patients were studied in 6/24. The studies on bacterial infections in general reported highly variable sensitivity and PPV for the diagnosis of infections using administrative data (sensitivity range 4.4-100%, PPV range 21.7-100%). Algorithms to identify opportunistic infections similarly had a highly variable sensitivity (range 20-100%) and PPV (1.3-99%). Thirteen studies compared the diagnostic accuracy of different algorithms which revealed that strategies including comprehensive algorithm using a greater number of diagnostic codes or codes in any position had the highest sensitivity for the diagnosis of infection. Algorithms which incorporated microbiologic or pharmacy data in combination with diagnostic codes had improved PPV for identification of tuberculosis.

Algorithms for identifying infections using administrative data should be selected based on the purpose of the study with careful consideration as to whether a high sensitivity or PPV is required.

This study aimed to describe the prevalence of sternoclavicular joint (SCJ) involvement and the relationship between clinical and US findings in patients with RA.

One hundred and three consecutive patients with RA and 103 age- and gender-matched healthy individuals were enrolled. Clinical evaluation and blinded US examinations of SCJ were performed bilaterally in both groups. Presence of grey scale synovitis, osteophytes, erosions and intra-articular PD were recorded. Inter-observer agreement was calculated

A total of 412 SCJ were evaluated: 206 from patients with RA, and 206 from healthy controls. In the RA group, 39 (19%) joints were found clinically involved (pain/swelling), in contrast with only four (3.9%) in the control group (p = 0.0001). In the RA group, US abnormalities were recorded in 89 (43%) SCJ compared with 36 (17%) in the healthy control group (p= 0.0001) comprising: osteophytes 59 (29%) vs. 25 (12%) p = 0.0001; synovitis 31 (15%) vs. 5 (2%) p = 0.0001, and erosions 23 (11%) vs. none p = 0.0001; intra-articular PD 5 (2%) vs. none of the controls (p = 0.03). Furthermore, a correlation between the presence of US synovitis (p <0.001) and intra-articular PD (p <0.0001) with higher DAS28 was found.

In patients with RA, US detected a higher number of involved SCJ than with clinical assessment. Our results indicate that both US grey scale and PD findings were more prevalent in patients with RA than in healthy controls. US synovitis and synovial hyperperfusion correlated with DAS28. suggesting that SCJ participate actively in the systemic inflammatory process of RA.

Research points to many potential benefits of physical activity (PA) for those with arthritis. However, PA has not typically been examined within the context of other life roles. This paper examines perceptions of PA among individuals managing arthritis in addition to employment and other role demands.

Eight focus groups were conducted with 24 women and 16 men (29-72 years) who were currently or recently employed (within 2 years) and had osteoarthritis or inflammatory arthritis. Participants were recruited from community newspaper advertisements, rheumatology clinics and arthritis groups. Discussions were audiotaped and transcribed. Transcripts were analyzed using qualitative content analysis.

All groups discussed the impact of arthritis on a range of physical activities. Overall, participants discussed PA as positively influencing their health and well-being. Yet, several overarching themes highlighted the complexity of PA, including: 1) PA as a potential cause of arthritis; 2) the reciprocal impact of arthritis on PA and PA on arthritis; 3) physical and psychological benefits and harms of PA like difficulty making PA decisions when living in pain or when faced with episodic symptoms; (4) perceived choices about engagement in PA (e.g., role overload); and (5) social support.

The relationships amongst work, health, and other roles were complex. Competing demands, pain, energy, episodic symptoms, support, and decisions to disclose one's illness at work influenced physical activity. Changes to PA not only affected physical health but also people's self-identity. PA interventions may be improved by taking into account the demands of multiple life roles.

To compare clinical characteristics and patient-reported outcomes in seropositive versus seronegative primary Sjogren's syndrome patients (pSS) and to investigate the effect of serological status on the prevalence of chronic pain, comorbidity and health quality.

Pain severity and neuropathic pain symptoms, comorbidity and health status were assessed in 108 pSS patients. Differences between patient groups were assessed by t-test and chi-square tests and adjusted pain-affect associations. The effect of predictor variables on pain severity was examined with multivariate regression.

Pain severity was greater (p=.003) and physical function (p=.023) reduced in the seronegative patients. Prevalence of neuropathic pain, depression, anxiety and disability were similar between groups. Chronic pain, defined as daily pain for greater than 3 months, was reported by 65% of seropositive (N=65) and 75% of seronegative patients (N=40). After adjustment for age, sleep quality and psychological distress, the difference in pain severity between seropositive and seronegative patients remained significant.

Chronic pain is pervasive in both seropositive and seronegative pSS patients, while pain severity and functional impairment is greater in seronegative patients. Neuropathic pain is equally prevalent and is the predominant pain phenotype in patients with moderate to severe pain. Accurate assessment of pain phenotypes is needed for more effective management of chronic pain in pSS. The focus of future research should be to standardize assessment of pain and to identify the factors contributing to more severe pain in seronegative patients.

To determine patient-derived weights or prioritisation for core outcome domains in chronic gout clinical studies.

Three patient groups participated in a conjoint decision making exercise using 1000Minds™ software that asked participants to make repeated judgements regarding which of two hypothetical patients with gout represented the best response to treatment. Each scenario compared two patients on the basis of change in two of five core outcome domains at a time. Agreement of 80% of the group was required to answer each scenario. Re-voting was performed once after discussion in instances of disagreement.

The relative importance accorded to each outcome domain was different across the three groups of patients. There was some consistency that tophi was the least or second to least important outcome domain for every group and pain between attacks was ranked in the bottom three of priority for all groups. Gout attacks were ranked second or third most important domain in each group. However, the relative importance of serum urate (SUA) and activity limitations was quite different among the three groups, with one group ranking SUA as the most important outcome and one group the second to least important outcome.

Despite some consistency in the relative value of some outcome domains for chronic gout studies, there is sufficient disagreement in the relative importance of other domains of outcome to challenge the validity of constructing a composite index of response that would be applicable to most gout patients.

To determine whether smoking reduces the progression of osteoarthritis (OA).

Observational studies examining smoking and progression of OA were systematically searched through Medline 1948-, Embase 1980-, Web of Science, PubMed and Google and relevant references. The search was last updated in May 2012. Odds ratio (OR) and 95% confidence interval (CI) were directly retrieved or calculated. Current standards for reporting meta-analyses of observational studies (MOOSE) were followed. Quality-related aspects such as study design, setting, sample selection, definition of progression and confounding bias were recorded. Stratified and meta-regression analyses were undertaken to examine the covariates.

16 studies (976,564 participants) were identified from the literature. Overall there was no significant association between smoking and progression of OA (OR = 0.92 95% CI 0.83 to 1.02). There was significant heterogeneity of results (I² = 57.3%; p=0.0024). Subgroup analyses showed some associations of marginal significance, however meta-regression did not confirm any significant results.

There is no compelling evidence that smoking has a protective effect on the progression of OA. The results concur with a previous meta-analysis published by this group which showed no association between smoking and incidence of OA. Taken together, smoking does not appear to reduce either the incidence or progression of OA. © 2013 by the American College of Rheumatology

Total knee arthroplasty (TKA) is a widely utilized and an effective treatment option for end-stage knee osteoarthritis (OA). Knee OA is more prevalent among women compared to men, but there are limited data on gender differences in surgical outcomes after primary TKA.

Our sample consisted of all primary TKAs performed in the State of Pennsylvania during the fiscal year 2002. We used ICD-9 codes to identify major complications and surgical revision. We used mixed effects logistic regression models to examine the associations between gender and all-cause mortality, readmissions, and major surgical complications. We used proportional hazards model to assess the risk of surgical revision after index arthroplasty. We adjusted for race, age, hospital teaching status, hospital procedure volume, insurance status and risk of mortality.

In 17,994 primary TKAs, there were 46deaths at 30-days and 220at one-year. Compared to women, men had higher adjusted odds of one-year mortality (Odds Ratio (OR)=1.48; 95% CI=1.13-1.94) after primary TKA. The overall odds of most major 30-day complications did not differ by gender, except surgical wound infections, which were higher in men compared to women (OR= 1.31; 95% CI=1.08-1.60); 30-day readmission was higher in men (OR=1.25; 95% CI=1.10-1.43). Men had significantly higher rates of index knee arthroplasty revision at 5-years (hazard ratio= 1.20; 95% CI=1.05-1.36) compared to women.

Higher rates of mortality, hospital readmissions, revision surgery and wound infections in men undergoing elective primary TKA, compared to women, indicates gender disparity in these outcomes. © 2013 by the American College of Rheumatology

To determine whether there is a systemic predisposition to chondrocalcinosis (CC) and to examine the association between CC and osteoarthritis (OA) at distant joints.

A cross sectional study embedded in GOAL (Genetics of Osteoarthritis and Lifestyle) database (n=3,170). All GOAL participants have had radiographs of knees, hands, and pelvis. These were scored for OA at the knee, hip, wrist, and MCPJ; for CC at the knee, hip, wrist, symphysis pubis, and for MCPJ calcification. Systemic predisposition to CC was established using cluster analysis. OR (95%CI) was used to examine the association between CC at index and distant joints; CC and OA at the same joint; and, index joint OA and distant joint CC. This was adjusted for age, gender, BMI; and for distant joint OA if required.

Joints with CC clustered together. This was observed when participants with OA were excluded from the analysis. CC at each joint associated with CC at distant joints. Knee and wrist OA but not hip OA associated with CC at same joint. MCPJ OA associated with MCPJ calcification. Knee OA associated with CC at other joints, and this was independent of OA at the distant joint. There was no association between hip OA and distant joint CC.

There is a systemic predisposition to the apparently sporadic CC. OA associates with CC at the same joint, and at distant joints, except hip OA which does not associate with hip CC, or with CC at distant joints. © 2013 by the American College of Rheumatology

To describe, and to identify the explanatory factors of variation in, current and maintained health-enhancing physical activity (HEPA) in persons with rheumatoid arthritis (RA).

In this cross-sectional study current HEPA was assessed with the International Physical Activity Questionnaire (IPAQ) and maintained HEPA with the Exercise Stage Assessment Instrument (ESAI), the latter explicitly focusing both aerobic physical activity and muscle strength training. Socio-demographic, disease-related and psychosocial data were retrieved from the Swedish Rheumatology Quality registers (SRQ) and a postal questionnaire. The explained variations in the respective HEPA behaviors were analyzed with logistic regression.

In all, 3152 (59 %) of 5391 persons identified as eligible from the SRQ, responded to the questionnaire. Current HEPA was reported by 69%, and maintained HEPA by 11% of the respondents. The most salient and consistent factors explaining variation in both current and maintained HEPA were self-efficacy, social support and outcome expectations related to physical activity.

To our knowledge this is the first study exploring maintained physical activity in a large well-defined sample of persons with RA. Our results indicate that a minority perform maintained HEPA, including both aerobic physical activity and muscle strength training, and that psychosocial factors are the most salient and consistent in the explanation of HEPA variation. © 2013 by the American College of Rheumatology

To describe the long-term physical functioning and its association with somatic comorbidity and comorbid depression in patients with established rheumatoid arthritis (RA).

Longitudinal data over a period of eleven years were collected from 882 patients with RA at study inclusion. Patient-reported outcomes were collected in 1997, 1998, 1999, 2002 and 2008. Physical functioning was measured with the Health Assessment Questionnaire and the Physical Component Scale of the Short Form-36 Health Survey. Somatic comorbidity was measured by a questionnaire including 13 chronic diseases. Comorbid depression was measured with the Center for Epidemiologic Depression Scale. We distinguished four groups of patients based on comorbidity at baseline.

78% of the patients at baseline were women. The mean age was 59.3 (SD 14.8) years and the median disease duration was 5.0 (IQR 2.0-14.0) years. For the total group of patients with RA physical functioning improved over time. Patients with somatic comorbidity, comorbid depression or both, demonstrated worse physical functioning than patients without comorbidity, at all data collection points. Both groups with comorbid depression had the lowest scores. Only patients with both somatic comorbidity and comorbid depression showed significantly less improvement in physical functioning over time.

Both somatic comorbidity and comorbid depression were negatively associated with physical functioning during an eleven-year follow-up period. Furthermore, their combination seems to be especially detrimental to physical functioning over time. These results emphasize the need to take somatic comorbidity and comorbid depression into account in the screening and treatment of patients with RA. © 2013 by the American College of Rheumatology

While patients with rheumatoid arthritis (RA) experience fatigue, little is known about its causes and consequences, and a fully developed theoretical model explaining the experience of fatigue in RA is lacking. Our goal was to systematically review studies in RA that examined factors related to fatigue to gain more insight into its possible causes and consequences.

MEDLINE, Web of Science, SCOPUS and PsychInfo were searched for relevant studies. All studies with RA samples about the relation between fatigue and other variables, that defined dependent and independent variables, and used multivariate statistical methods were preliminarily included. After reviewing 129 full-texts, we identified twenty-five studies on possible causes of fatigue and seventeen studies on possible consequences of fatigue.

Studies found possible causes of fatigue in illness-related aspects, physical functioning, cognitive/emotional functioning and social aspects. Additionally, being female was related to higher levels of fatigue. Inflammatory activity showed an unclear relationship with fatigue in RA. Possible consequences of fatigue were also found among illness-related aspects, physical functioning, cognitive/emotional functioning and social aspects. Strongest evidence for a relationship between fatigue and other variables was found regarding pain, physical functioning and depression.

This review summarizes the current knowledge in the field in order to inform future research on causes and consequences of fatigue in RA. However, the results are based on cross-sectional and longitudinal studies with different designs and different fatigue scales. For a better identification of causal associations between fatigue in RA and related factors, longitudinal prospective designs with adequate fatigue measurements are suggested. © 2013 by the American College of Rheumatology

To investigate the outcome and predicting factors of multiple intra-articular corticosteroid (IAC) injections in children with juvenile idiopathic arthritis (JIA).

The clinical charts of patients who received their first IAC injection in > 3 joints between January 2002 and December 2011 were reviewed. The corticosteroid used was triamcinolone hexacetonide for large joints and methylprednisolone acetate for small or difficult to access joints. In each patient, the follow-up period after IAC injection was censored in case of synovitis flare or at last visit with continued remission. Predictors included sex, age at disease onset, JIA category, antinuclear antibody (ANA) status, age and disease duration, disease course, general anesthesia, number and type of injected joints, acute phase reactants, and concomitant systemic medications.

A total of 220 patients who had 1096 joints injected were included. Following IAC therapy, 66.4% of patients had synovitis flare after a median of 0.5 years, whereas 33.6% of patients had sustained remission after a median of 0.9 years. The cumulative probability of survival without synovitis flare was 50.0%, 31.5% and 19.5% at 1, 2 and 3 years, respectively. On Cox regression analysis, positive C-reactive protein, negative ANA, lack of concomitant methotrexate administration, and a polyarticular (versus an oligoarticular) disease course were the strongest predictors for synovitis flare.

Multiple IAC therapy induced sustained remission of joint synovitis in a substantial proportion of patients. A controlled trial comparing multiple IAC therapy and methotrexate versus methotrexate and a tumor necrosis factor antagonist is worthy of consideration. © 2013 by the American College of Rheumatology

Loss of participants in longitudinal data collection can affect the validity of outcomes in Rheumatoid Arthritis (RA) registries. Prior research indicates that demographics, socioeconomic and psychosocial factors contribute to attrition. This study analyzes the characteristics of an RA registry that may contribute to attrition in a hospital-based population.

Subjects were RA patients enrolled in the Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS). Demographics, clinical and psychological factors were evaluated in univariate analyses to determine differences between participants who dropped out and those who completed five years of follow-up. Univariate factors with a p<0.1 were used in a survival analysis to determine significant factors associated with attrition. A secondary analysis looked at patients who dropped out during the first year.

1,144 RA participants were enrolled (509 completed five years, 227 still actively enrolled, and 408 dropped out). The attrition rate was 4.31% per six month cycle. Shorter disease duration, higher disease activity (DAS28-CRP3), less education, RA drug therapy and lower Arthritis Self-Efficacy were statistically significant in multivariate survival analyses. In a secondary analysis, gender and age were the only additional factors found that contributed to attrition.

The attrition rate for this registry was similar to rates reported by other registries. Shorter disease duration, higher disease activity, and several other socioeconomic factors were associated. Males and younger patients tended to dropout during the first year. Population differences in each registry may result in different attrition patterns and ultimately, each longitudinal registry should consider conducting its own analyses. © 2013 by the American College of Rheumatology

Osteoarthritis is acknowledged as an enduring condition, however, in epidemiological studies, half the participants who report having osteoarthritis at one time may report not having it at a subsequent time. The aim of this study was to examine whether variations in reporting doctor-diagnosed osteoarthritis reflected concurrent fluctuations in indicators of disease severity in mid-age women.

Data were from 7,623 participants (aged 50-55 years in 2001) in the Australian Longitudinal Study on Women's Health. Based on self-report of doctor-diagnosed osteoarthritis at surveys in 2001, 2004, 2007 and 2010, the participants were classified according to pattern of osteoarthritis reporting (e.g. 0-0-0-0=‘no’ on all surveys, 0-1-0-1=‘no-yes-no-yes’). Indicators of disease severity included frequency of joint pain/stiffness, use of anti-inflammatory medications, and physical functioning assessed with the SF-36. Bar graphs were used to show concurrent variations in osteoarthritis and markers, and associations were examined using log-linear models.

In this sample, 46% reported having osteoarthritis on at least one survey, with half these cases reporting not having osteoarthritis at a later survey. Odds of reporting joint pain/stiffness often (odds ratio (OR) 7.26, 95% confidence interval (CI) 7.06-7.47) and using anti-inflammatory drugs (OR 4.44, CI 2.37-8.33) were higher, and physical functioning scores were lower (OR 3.75, CI 3.56-3.95) when participants reported having osteoarthritis.

Variations in reporting osteoarthritis coincided with episodic fluctuations in symptoms and functioning. Inconsistent reporting of osteoarthritis could therefore reflect presence of symptoms rather than reporting error and should be considered in longitudinal studies. © 2012 by the American College of Rheumatology

Although diabetes mellitus (DM) has been suggested as a risk factor of adhesive capsulitis of the shoulder (ACS), data on the temporal association between these two conditions are sparse. The purpose of this population-based, age- and sex- matched cohort study was to investigate the risk of developing ACS in patients with newly diagnosed DM.

A total of 78827 subjects with at least two ambulatory visits with the principal diagnosis of DM in 2001 were recruited in the DM group. The non-DM group comprised 236481, age- and sex-matched randomly sampled subjects without DM. The three-year cumulative risk of ACS was calculated using the Kaplan-Meier method. A Cox proportional hazards regression model was used to estimate the crude and adjusted hazard ratio (HR) of ACS.

During the three-year follow-up, 946 (1.20%) subjects in the DM group and 2254 (0.95%) subjects in the non-DM group developed ACS. The crude HR of developing ACS for the DM group compared to the non-DM group was 1.333 (95% 1.236 – 1.439; p value < 0.0001), whereas the adjusted HR was 1.321 (95% 1.224 – 1.425; p value < 0.0001) after adjustment for age, sex, and dyslipidemia.

This longitudinal population-based follow-up study shows a significantly increased risk of developing ACS after DM. © 2012 by the American College of Rheumatology

We tested the hypothesis that initiation of TNFα antagonists reduced the risk of fractures compared to nonbiologic comparator in patients with autoimmune diseases.

Using four large administrative databases, we assembled retrospective cohorts of patients with autoimmune diseases who initiated either a TNFα antagonist or a nonbiologic medication. We identified 3 mutually exclusive disease groups: rheumatoid arthritis (RA); inflammatory bowel disease (IBD); and psoriasis, psoriatic arthritis or ankylosing spondylitis (PsO-PsA-AS). We used baseline covariate data to calculate propensity scores (PS) for each disease group and used Cox regression to calculate hazard ratios (HR) and 95% confidence intervals (95%CI). We compared the risk of combined hip, radius/ulna, humerus, or pelvic fractures between PS-matched cohorts of new users of TNFα antagonists and nonbiologic comparator.

We identified 9,020, 2,014 and 2,663 new PS matched episodes of TNFα antagonist and nonbiologic comparator use in RA, IBD and PsO-PsA-AS cohorts, respectively. The risk of combined fractures was similar between new users of TNFα antagonists and nonbiologic comparators for each disease (HR: 1.17, 95%CI [0.91, 1.51]; HR: 1.49, 95%CI [0.72, 3.11]; and HR: 0.92, 95%CI [0.47, 1.82] for RA, IBD and PsO-PsA-AS, respectively). In RA, the risk of combined fractures was associated with an average daily dose of prednisone equivalents >10 mg/day at baseline compared with no glucocorticoid (HR: 1.54, 95%CI [1.03, 2.30]).

The risk of fractures did not differ between initiators of a biologic and a nonbiologic comparator for any disease studied. Among RA patients, use of >10mg/day of prednisone equivalents at baseline increased the fracture risk. © 2012 by the American College of Rheumatology

American Council on Graduate Medical Education (ACGME) program requirements mandate that rheumatology training programs have written goals, objectives and performance evaluations for each learning activity (LA). Since LAs are similar across rheumatology programs, we aimed to create competency-based goals and objectives (CBGO) and evaluations that would be generalizable nationally.

Through an established collaboration of the four training programs' directors in North and South Carolina, we collaboratively composed CBGO and evaluations for each LA for rheumatology training programs. CBGO and linked evaluations were written using appropriate verbs based on Bloom's taxonomy. Draft documents were peer reviewed by faculty at the four institutions and by members of the ACR Clinician Scholar Educator Group.

We completed templates of CBGO for core and elective rotations and conferences. Templates detail progressive fellow performance improvement appropriate to educational level. Specific CBGO are mirrored in LA evaluations. Templates are easily modified to fit individual program attributes, have been successfully implemented by our four programs, and have proven their value in 4 Residency Review Committee reviews.

We propose adoption of these template CBGO by the American College of Rheumatology, with access available to all rheumatology training programs. Evaluation forms that exactly reflect stated objectives ensure that trainees are assessed using standardized measures and that trainees are aware of the learning expectations. The objectives mirrored in the evaluations closely align with the proposed milestones for internal medicine training, and will therefore be a useful starting point for creating these milestones in rheumatology. © 2012 by the American College of Rheumatology

To determine the incidence, time trends,risk factors and severityof herpes zoster (HZ) in a population-based incidence cohort of patients with rheumatoid arthritis (RA) compared to a group of individuals without RA from the same population.

All residents of Olmsted County, MN who first fulfilled 1987 AmericanCollege of Rheumatology criteria for RA between 1/1/1980 and 12/31/2007 and a cohort of similar residents without RA were assembled and followed by retrospective chart review until death, migration, or 12/31/2008.

There was no difference in the presence of HZ prior to RA incidence/index date between the cohorts (p=0.85). During follow-up 84 patients with RA (rate: 12.1 per 1000 person-years) and 44 subjects without RA (rate: 5.4 per 1000 person-years) developed HZ. Patients with RA were more likely to develop HZ than those withoutRA(hazard ratio: 2.4; 95% confidence interval: 1.7, 3.5). Patients diagnosed with RA in 1995-2007 had a higher likelihood of developing HZ than those diagnosed in 1980-1994. Erosive disease, previous joint surgery, use of hydroxychloroquine and corticosteroids were significantly associated with the development of HZ in RA, while the use of methotrexate or biologic agentswas not.Complications of HZ occurred at a similar rate in both cohorts.

The incidence of HZ is increased in RA and has risen in recent years. The increasing incidence of HZ in more recent years is also noted in the general population. RA disease severity is associated with development of HZ. © 2012 by the American College of Rheumatology

To determine whether there are racial differences in social support among patients with knee osteoarthritis (OA) and whether the impact of social support on patient preferences for total knee replacement (TKR) varies by race and gender.

514 white & 285 African-American (AA) patients with knee OA were surveyed. Logistic regression models were performed to determine if the relationship between willingness to undergo TKR and the interaction of patient race and sex were mediated by social support.

Compared to whites with knee OA, AA patients were less likely to be married (p<0.001), reported less close friends/relatives (p<0.001) and had lower Medical Outcomes Study-Social Support Scale (MOS-SSS) scores (p<0.001). AA patients were also less willing to undergo TKR (62% vs. 80%, p<0.001) than whites.

The odds of willingness to undergo TKR was less in white females compared to white males when adjusted for recruitment site, age, income and WOMAC (OR 0.57, 95% CI 0.34-0.96). This difference was no longer significant when further adjusted for marital status, number of close friends/relatives and MOS-SSS score, but the effect size remained unchanged (OR 0.60, 95% CI 0.35-1.02). The odds of willingness to undergo TKR remained much less in AA females (OR 0.35, 95% CI 0.19-0.64) and AA males (OR 0.28, 95% CI 0.14-0.54) compared to white males when controlled for sociodemographic, clinical and social support measures.

AA patients reported less structural and functional social support than whites. Social support is an important determinant of preference for TKR surgery only among whites. © 2012 by the American College of Rheumatology

To investigate the associations between cardiorespiratory fitness (CRF) and level of cardiovascular (CV) risk factors in patients with ankylosing spondylitis (AS) and controls.

In a cross sectional comparative study CRF was measured with a maximal treadmill test for estimation of peak oxygen uptake. Metabolic syndrome (MS), body composition, traditional CV risk factors and inflammatory markers were assessed. Multivariable linear regression models were used to study the associations between CRF and CV risk factors. All models were adjusted for age, gender and smoking, and adjusted for inflammation when C-reactive protein (CRP) or sedimentation rate (SR) were not already included as dependent variables.

126 patients (mean age 47.9 (SD 10.8)) and 111 controls (mean age 52.1 (SD 11.1)) were included. For patients and controls there were significant inverse associations between CRF and body mass index, waist circumference, triglycerides, CRP and SR (p=<0.001-0.03). Also, significant associations were found between CRF and HDL cholesterol (β=0.03, p<0.001) and blood pressure (BP) (Systolic, β=-0.9, diastolic, β=-0.6, p<0.01) in controls, but these associations were not found in patients (HDL-cholesterol: β=0, p=0.69, systolic: β=-0.04, p=0.87, diastolic: β=-0.14, p=0.34) (additional adjustments for medication). Higher CRF was associated with a lower risk for MS in both patients (OR=0.91, p=0.03) and controls (OR=0.89, p=0.01).

CRF was associated with favorable levels of CV risk factors and lower risk of MS in both AS patients and controls. However, established findings of an association between CRF and BP and HDL-cholesterol in healthy adults were not confirmed in AS patients. © 2012 by the American College of Rheumatology

To estimate the nationwide incidence of rheumatoid arthritis (RA) including its variation across age, sex, geography and demography, in Sweden, and to describe the sensitivity of register-based incidence estimates to different RA case definitions.

Incident RA patients were identified using the Swedish National Patient Register. In the base case, incident RA was defined as 1^st ever inpatient or nonprimary outpatient care visit listing an RA-diagnosis in 2006-2008, with a 2^nd visit listing RA within one year. Patients prescribed disease-modifying anti-rheumatic drugs more than 6 months prior to the first visit listing RA were not regarded as incident. The robustness of this definition was evaluated by more liberal and strict criteria and by penetration of anti-rheumatic treatment.

Between 2006 and 2008 8,826 individuals were identified as incident RA patients. The overall incidence was 41 per 100,000 (56 for women, 25 for men). The incidence increased with age and peaked in the 70-79y group for both women and men. The age/sex-standardized incidences were lower in densely populated areas, and in individuals with high educational level. No geographical trends were noted. More liberal and strict definitions of RA only altered the observed incidence by around 14%.

The overall nationwide register-based incidence of RA was robust across different case definitions. In a country with universal access to care, RA displayed demographic and socioeconomic but no geographic variations in incidence, and peaks at an older age than most commonly reported, with no difference in peak age of RA onset between sexes. © 2012 by the American College of Rheumatology

The purpose of the study was to compare the incidence and progression of radiographic osteoarthritis (OA) in the knee and hip among African Americans and Caucasians.

Using the joint as a unit of analysis, we analyzed data from the Johnston County Osteoarthritis Project, a population-based prospective cohort study in rural North Carolina. Baseline and follow-up assessments were 3-13 years apart. Assessments included standard knee and hip radiographs read for Kellgren-Lawrence (KL) radiographic grade. Weighted analyses controlled for age, gender, body mass index (BMI), level of education, and baseline KL grade; bootstrap methods adjusted for lack of independence between left and right joints. Time-to-event analysis was used to analyze the data.

For radiographic knee OA, being African American had no association with incidence (adjusted hazard ratio [aHR] 0.80, 0.53 to 1.22) but had a positive association with progression (aHR 1.67, 1.05 to 2.67). For radiographic hip OA, African Americans had significantly lower incidence (aHR 0.44, 0.27 to 0.71) while the association with progression was positive but non-significant (aHR 1.46, 0.53 to 4.01). In sensitivity analyses, the association with hip OA incidence was robust to a wide range of assumptions.

African Americans are protected against incident hip OA but may be more susceptible to progressive knee OA. © 2012 by the American College of Rheumatology

To identify predictors of pain at one year in patients with early inflammatory polyarthritis (EIA).

Using a prospective design, patients were examined by a rheumatologist, and completed questionnaires at baseline and at one year after symptom onset. Separate regression analyses were run for pain intensity, sensory pain, and affective pain. Age and gender were adjusted in cross-sectional and longitudinal analyses; baseline potential predictors were: measures for corresponding pain values; disease activity, depression, coping scores, medication use, RA criteria being met, and duration of symptoms.

211 patients were enrolled in the study (mean age =58.8, SD =14.2; 63% female). There were significant improvements at one year for: disease activity, instrumental coping, emotional coping, depression, and all three pain measures. At baseline, disease activity and depression were positively associated with all types of pain; in addition, instrumental coping was positively associated with sensory pain and palliative coping was positively associated with affective pain. At one year, pain intensity was predicted by the baseline pain intensity, duration of symptoms, DMARD use emotional coping. Sensory pain was predicted by baseline sensory pain, and DMARD use. Affective pain was predicted by baseline affective pain, DMARD use, and emotional coping.

The majority of treated EIA patients can expect improvements in clinical and psychosocial variables over the first year of their illness. Emotional coping at baseline may contribute to pain in the future and therefore it may be useful for patients to learn other means of dealing with this chronic disease. © 2012 by the American College of Rheumatology

To relate serum leptin levels to prevalent and incident radiographic knee osteoarthritis (OAK) and to determine if patterns of change in longitudinal serum leptin measures differ by knee OA status over a 10-year period.

Participants in the Michigan Study of Women's Health Across the Nation underwent bilateral knee radiographs at baseline and follow-up visits 2, 4 and 11 for ascertainment of OAK status (Kellgren-Lawrence score ≥ 2). Serum leptin measures were available from baseline, follow-up visits 1 and 3-7.

The baseline prevalence of OAK (average age 46 years) was 18%; the two-year incidence of OAK at follow-up visits 2 and 4 was 18% and 14%, respectively. Serum leptin levels were associated with prevalent and incident OAK. A 5 ng/mL increase in serum leptin was associated with 38% higher odds of prevalent OAK (OR=1.38, 95% CI 1.26, 1.52) and with 31% greater odds of incident OAK (OR=1.31, 95% CI 1.21, 1.41) after adjustment for covariates including BMI residuals. Leptin levels increased with time; on average, serum leptin levels increased by 0.38 ng/mL per year (p=0.0004). Women with incident OAK during the 10-year follow-up had consistently higher serum leptin levels as compared to women with no OAK during follow-up.

Our findings support a metabolic role of obesity on knee OA. Better understanding of the mechanisms by which increased fat mass is associated with joint damage is needed. Management of cardiometabolic dysfunction, including elevated serum leptin levels may be beneficial in forestalling the onset or progression of knee OA. © 2012 by the American College of Rheumatology

Little is known about the impact of family environment on the long-term adjustment of patients with juvenile-onset fibromyalgia (JFM).

To evaluate whether family environmentin early adolescence predictedlater physical functioning and depressive symptoms of adolescents with JFM as they transition to early adulthoodin the context of a controlled long-term follow-up study.

Participants were 39 youth(M_age = 18.7 years) with JFM and 38 healthy matched controls who completed web-based surveys about their health status (SF-36 Health Survey) and depressive symptoms (Beck Depression Inventory II) approximately 4 years after a home-based, in-person assessment of child and family functioning. During the initial assessment, parents of participants (94% mothers) completed the Family Environment Scale, and adolescents (M_age = 14.8 years) completed self-report questionnaires about pain (Visual Analog Scale) and depressive symptoms (Children's Depression Inventory).

Results indicated that family environment during early adolescence significantly predicted greater depressive symptoms in early adulthood for both the JFM group and healthy controls. In particular, a controlling family environment (use of rules to control the family and allowing little independence) during early adolescence was the driving factor in predicting poorer long-term emotional functioning for patients with JFM. Family environment did not significantly predict longer-term physical impairment for either group.

Adolescents with JFM from controlling family environments are at increased risk for poorer emotional functioning in early adulthood. Behavioral and family interventions should foster independent coping among adolescents with JFM and greater parenting flexibility to enhance successful long-term coping. © 2012 by the American College of Rheumatology

To examine cross-sectional baseline data from the Johnston County Osteoarthritis Project for the association between individual and community socioeconomic status (SES) measures with hip osteoarthritis (OA) outcomes.

We analyzed data on 3,087 individuals (68% Caucasian and 32% African American). Educational attainment and occupation were used as individual measures of SES. Census block group household poverty rate was used as a measure of community SES. Hip OA outcomes included radiographic OA (rOA) and symptomatic OA (sxOA) in one or both hip joints. Multivariable logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (CI) for the association of each hip OA outcome with each SES variable separately, then with all SES measures simultaneously. Associations between hip OA outcomes and SES variables were evaluated for effect modification by race and gender.

Living in a community of high household poverty rate showed independent associations with hip rOA in one or both hips (OR=1.50; 95% CI=1.18-1.92) and bilateral (both hips) rOA (OR=1.87; 95% CI=1.32-2.66). Similar independent associations were found between low educational attainment among those with sxOA in one or both hips (OR=1.44; 95% CI=1.09, 1.91) or bilateral sxOA (OR=1.91; 95% CI=1.08-3.39), after adjusting for all SES measures simultaneously. No significant associations were observed between occupation and hip OA outcomes, nor did race or gender modify the associations.

Our data provide evidence that hip OA outcomes are associated with both education and community SES measures, associations which remained after adjustment for covariates and all SES measures. © 2012 by the American College of Rheumatology

To evaluate the cross-cultural measurement equivalence of the US and Dutch Health Assessment Questionnaire II (HAQ-II) in rheumatoid arthritis (RA).

Item response theory (IRT) analyses were performed on US (n=18747) and Dutch (n=1022) HAQ-II data to evaluate the equivalence of cross-cultural item performance. Observed inconsistencies were modeled by assigning country-specific item parameters to biased items. The impact of cross-cultural item bias on the comparability of the Dutch and US total scores was analyzed by evaluating the agreement between physical function levels estimated from an IRT model with country specific-item parameters for biased items and the physical function levels estimated from the original model that does not account for cultural bias.

Two items showed significant cross-cultural bias. However, the agreement in physical function estimates between the respecified and original model was very high with ICC >0.99 and the Bland–Altman limits of agreement ranging from -0.08 to 0.07 on a latent scale with a mean of 0 and standard deviation 1.

This study suggests that the Dutch and US HAQ-II produce total scores that can be interpreted interchangeably across countries in RA studies, despite some minor bias at the item level. © 2012 by the American College of Rheumatology

To determine why multimorbidity causes participation restriction in adults aged 50 years and over who consult primary care with lower limb osteoarthritis.

Population-based prospective cohort study of 1053 consulters for lower limb osteoarthritis who were free of participation restriction at baseline. Path analysis was used to test proposed mechanisms by examining for mediation of the association between multimorbidity at baseline, defined by self-report and consultation data separately, and incident participation restriction at three years by lower limb pain severity, obesity, locomotor disability and depression.

Multimorbidity was associated with incident participation restriction (Adjusted Odds Ratio 2.83; 95%CI 2.03, 3.94 for multimorbidity (self-report); 1.59; 1.15, 2.21 for multimorbidity (consultation data). The extent of mediation of the association of baseline multimorbidity, defined by self-report, and incident participation restriction was greater for severe lower limb pain than obesity (standardized beta coefficients for indirect effect 0.032 (SE 0.015) and 0.020 (0.019) respectively). The addition of depression and locomotor disability increased the amount of mediation (0.115 (0.028)) and reduced the proportion explained by severe lower limb pain (0.014 (0.015)) and obesity (0.006 (0.010)). Locomotor disability was the strongest mediator.

The additional impact on participation in social and domestic life which multimorbidity places on individuals with lower limb osteoarthritis appears to be mediated through further restriction of locomotor disability as well as through depression. The results suggest that the effect of multimorbidity on the daily lives of people with lower limb osteoarthritis will be ameliorated by active management of depression and locomotor disability. © 2012 by the American College of Rheumatology

To define the core content for an opportunistic consultationbetween a health care professional and a patient with osteoarthritis(OA)in primary care.

An ideas generation round and a two round Delphi postal consensus study allowed participants to rank the importance of tasks for an opportunistic consultation.The studywas conducted with a lay group (n=18) andthree groups of health care professionals(GPs (n=30), Practice Nurses (n=19), Allied Health Professionals (n=37)).

The ideas generation round formulated 35 consultation tasks. There was a 50% response rate to the two round postal exercise (n=52). Consensus was reached on 12tasks for an opportunisticOA consultation using a >80% level of agreement across all groups.Three of these consultation tasks were defined at 100%. The three taskswere: the healthcare professional i) enquires how things are going with the condition ii) asks about the type and amount of pain the patient has and iii) asks whether the patient is taking regular analgesia.

In aDelphi study to define the content of an opportunistic primary care OA consultation, 12 consultation tasks provided the content of a comprehensive consultation. Three of these tasks with 100% agreement could be adopted in any multidisciplinary consultation for OA in primary care. Enquiring about the condition, the type and amount of pain the patient has and whether analgesia is being taken, form a core set of questions that both a lay group and a health professional group consider important in an opportunistic consultation. © 2012 by the American College of Rheumatology

Persons with systemic lupus erythematosus (SLE) are at increased risk of cardiovascular disease (CVD) events, but this excess CVD burden in the perioperative setting is yet to be determined. We aimed to determine the risk of perioperative short-term all-cause mortality and CVD events among women with SLE compared to those without SLE.

We conducted a cross-sectional analysis of pooled hospital discharge data from years 1998 to 2002 of the Nationwide Inpatient Sample. We abstracted diseases and procedures using International Classification of Diseases, Ninth Revision (ICD-9-CM) codes. The principal procedure was categorized into either a low, intermediate, or high risk level. Survey logistic regression adjusting for potential confounders provided estimates for stratum-specific odds of adverse events in women with SLE relative to those without SLE for each procedure risk level. All-cause mortality was significantly greater among women with SLE having a low (Odds Ratio [OR] 1.54; 95% Confidence Interval [CI] 1.00-2.37) or a high risk principal procedure (OR 2.52; 95% CI 1.34-4.75) relative to women without SLE, but did not differ significantly among persons with intermediate risk procedures. Women with SLE with a low risk procedure were also more likely to experience a composite CVD event relative to women without SLE (OR 1.40; 95% CI 1.04-1.87).

Women with SLE are at increased risk for short-term perioperative adverse events. These results highlight a need for greater scrutiny during perioperative evaluation and management of women with SLE. © 2012 by the American College of Rheumatology

Measuring physical activity in people with rheumatoid arthritis (RA) is of increasing importance in light of the increased mortality in this population due to cardiovascular disease. Validation of activity monitors in specific populations is recommended to ensure the accuracy of physical activity measurement. Thus, the purpose of this study was to determine the validity of SenseWear Pro3Armband (SWA) as a measure of physical activity during activities of daily living (ADLs) in people with RA.

Fourteen subjects (8 male, 6 female) with a diagnosis of RA were recruited from rheumatology clinics at the Mid-Western Regional Hospitals, Limerick, Ireland. Participants undertook a series of ADLs of varying intensities. SWA was compared to the criterion measures of Oxycon mobile indirect calorimetry system (energy expenditure in kJ) and manual video observation (step count). Bland and Altman, ICC and correlational analyses were utilised using SPSS version 19.0.

SWA shows substantial agreement (ICC = 0.717, p<0.001) and a strong relationship (Pearson correlation = 0.852) when compared with the criterion measure when estimating energy expenditure during ADLs. However, it was found that SWA overestimates energy expenditure particularly at higher intensity levels. The ability of SWA to estimate step counts during ADLs was shown to be poor (ICC = 0.304, p = 0.038).

SWA can be considered a valid tool to estimate energy expenditure in the RA population during ADLs; however regard should be paid to its tendency to overestimate energy expenditure. © 2012 by the American College of Rheumatology

To evaluate the metrological properties of composite disease activity indices in rheumatoid arthritis (RA), utilizing information derived from clinical, grey-scale (GS) and Power Doppler (PD) ultrasound examination. To assess the classification of patients according to disease activity using such indices.

This ancillary study utilized data from a prospective, randomized, parallel-group, multicenter study conducted in subjects with moderate RA, randomized to receive etanercept and methotrexate (ETN+MTX) or usual care (various DMARDs). In multimodal indices the 28-swollen joint count (SJC) was either supplemented or replaced by clinically non-swollen joints in which the presence of synovitis was detected either by GS and/or PD and were calculated according to the DAS28 or SDAI indices. Reliability, external validity and discriminative capacity were calculated at baseline/screening by intraclass correlation coefficient, Pearson's correlation and standardized response mean respectively.

Data from 62 patients (age: 53.8±13.2 years; disease duration: 8.8±7.7 years; disease activity: 4.6± 0.5 (DAS28), 20.9± 5.9 (SDAI)) were analyzed, 32 receiving ETN+MTX and 30 receiving DMARDs. The metrological properties were at least as good for GS and/or PD-based indices as for their clinical counterparts. Using GS and PD supplemented indices an additional 67.8% and 32.3% (DAS28-derived and SDAI-derived indices respectively) of patients could be classified as having high disease activity at the screening visit.

Multimodal indices incorporating ultrasound and clinical data had similar metrological properties as their clinical counterparts; certain indices allowed for a significantly larger number of patients to be classified to either high or moderate disease activity at the screening visit. © 2012 by the American College of Rheumatology.

This study aimed to assess the ability of ultrasonography (US) to predict radiographic damage in early arthritis.

ESPOIR is a multicentric cohort of early arthritis (i.e. ò 2 swollen joints between 6 weeks and 6 months). US synovitis in B mode and power Doppler (PD) and erosions were searched on MCP2 to 5 and MTP5 according to OMERACT definitions. Structural radiographic progression was assessed using the SHS erosion score at baseline, 1 and 2 years. Predictive factors of erosive arthritis at 2 years and rapid radiographic progression (RRP) at 1 year (defined by change of SHS erosion score ò 5) were searched.

127 patients were included: DAS28 5.1±1.3; 37.6% ACPA-positive; 27.6% with typical rheumatoid arthritis (RA) erosions on X-rays. At 2 years, 42 (39.2%) patients had typical RA erosions. US erosions predicted radiographic evidence of erosive arthritis (OR 1.44, 95% CI 1.04, 1.98). PD synovitis score was predictive of RRP at 1 year (OR 1.22, 95% CI 1.04, 1.42). US erosions and PD synovitis scores were associated with change of SHS erosion score on linear regression. On the 1184 analyzed joints, 105 (8.9%) had radiographic erosion at 1 year. At joint level, baseline US erosions were predictive of the presence of radiographic erosions at 1 year (p<0.001). The same trend was observed in the joints without radiographic erosions at baseline (p=0.052).

US is useful to evaluate the potential severity of early arthritis: US erosions and PD positive synovitis have prognostic value to predict future radiographic damage. © 2012 by the American College of Rheumatology

A lack of agreement between clinician and patient priorities can impact on the clinician-patient relationship, treatment concordance and potentially health outcomes. Studies have suggested that patients with OA may prioritise co-morbidities over their OA, but as yet no explicit systematic exploration of OA patients' priorities in relation to co-morbidities exists. This paper aims to explore how patients prioritise OA amongst their conditions, what factors underlie this prioritisation and whether and why these priorities change over time.

A secondary analysis of qualitative data was conducted utilising 4 existing datasets collated from the 3 research centres involved. Purposive sampling provided a sample of 30 participants who all had OA and co-morbidities. The research team collectively coded and analysed the data thematically.

Three groups of patient emerged from the analysis. The two smaller groups had stable priorities (where OA was or was not prioritised) and illustrated the importance of factors such as personal social context and the specific nature of the co-morbid conditions. The third and largest group reported priorities that shifted over time. Shifting appeared to be influenced by participants' perceptions of control and/or interactions with clinical professionals, and could have important consequences for self-management behaviour.

The various factors underlying patients' priorities amongst their conditions and the fluctuating nature of these priorities highlights the importance of regular assessments during clinician-patient consultations to allow better communication and treatment planning and ultimately optimise patient outcomes. © 2012 by the American College of Rheumatology

To validate an MRI reference criterion for a positive SIJ MRI based on the level of confidence in classification of spondyloarthritis (SpA) by expert MRI readers.

Four readers assessed SIJ MRI in two inception cohorts (A/B) of 157 consecutive back pain patients ≤50 years, and in 20 healthy controls. Patients were classified according to clinical examination and pelvic radiography as having non-radiographic axial SpA (n=51), ankylosing spondylitis (n=34), or non-specific back pain (n=72). Readers recorded their level of confidence in the classification of SpA on a 0-10 scale (0=definitely not; 10=definite). The MRI reference criterion was pre-specified as the majority of readers recording a confidence of 8-10; absence of SpA required all readers to record Non-SpA (confidence 0-4). We calculated inter-reader reliability and agreement between MRI-based and clinical classification using kappa statistics. We estimated cut-off values for MRI lesions attaining specificity `0.90 for SpA.

76.4%/71.6% of subjects in cohorts A/B met the MRI criterion. Kappa values for inter-reader agreement were 0.76/0.80, and between MRI-based and clinical assessment 0.93/0.57. Using this MRI reference criterion, the cut-off for number of affected SIJ quadrants needed to reach a pre-defined specificity `0.90 was `2/`2 for BME and `1/`1 for erosion in cohorts A/B, and both lesions BME and/or erosion increased sensitivity without reducing specificity.

This data-driven study using two inception cohorts and comparing clinical and MRI-based classification supports the case for including both erosion and BME to define a positive SIJ MRI for the classification of axial SpA. © 2012 by the American College of Rheumatology

The impact of knee arthroplasty on body weight has not been fully explored. Clinically important weight gain following knee arthroplasty would pose potentially important health risks.

We used one of the largest US-based knee arthroplasty registries and a population-based control sample from the same geographic region to determine whether knee arthroplasty increases the risk of clinically important weight gain of ≥5% of baseline body weight over a 5-year postoperative period.

Of the persons in the knee arthroplasty sample, 30.0% gained ≥5% of baseline body weight 5 years following surgery as compared to 19.7% of the control sample. The multivariable-adjusted (age, sex, body mass index, education, comorbidity, and presurgical weight change) odds ratio (OR) was 1.6 (95% confidence interval [95% CI] 1.2–2.2) in persons with knee arthroplasty as compared to the control sample. Additional arthroplasty procedures during followup further increased the risk for weight gain (OR 2.1, 95% CI 1.4–3.1) relative to the control sample. Specifically, among patients with knee arthroplasty, younger patients and those who lost greater amounts of weight in the 5-year preoperative period were at greater risk for clinically important weight gain.

Patients who undergo knee arthroplasty are at an increased risk of clinically important weight gain following surgery. The findings potentially have broad implications to multiple members of the health care team. Future research should develop weight loss/maintenance interventions particularly for younger patients who have lost a substantial amount of weight prior to surgery, as they are most at risk for substantial postsurgical weight gain.

Genetic hemochromatosis (GH) is an autosomal recessive disease in individuals of Northern and Western European descent. Heterozygosity for the C282Y mutation is common (6–20%). Arthropathy is one of the few complications of GH suggested not to be associated with iron body stores; synovial iron deposition remains in iron-depleted patients. Previous studies suggest an elevated prevalence of clinical and radiographic signs of arthropathy in patients with GH, and 2 smaller studies suggest a possibly elevated risk of joint replacement surgery, but more mixed results are shown regarding risks with HFE genotype. We therefore assessed the risks of arthropathy and joint replacement surgery in patients with GH and in their first-degree relatives (FDRs).

We performed a population-based cohort study of 3,531 patients with GH and of their 11,794 FDRs (assumed to be heterozygous for the C282Y mutation) using nationwide Swedish population-based health and census registers. Hazard ratios (HRs) of arthropathies and joint replacement surgeries among patients and their FDRs (versus the general population) were assessed using Cox regression.

Between 1997 and 2005, 406 of 3,531 patients were reported/hospitalized with any noninfectious arthropathies, including osteoarthritis, corresponding to an HR of 2.38 (95% confidence interval [95% CI] 2.14–2.64). Patients were also at increased risk of hip replacement (HR 2.77, 95% CI 2.27–3.38) and knee replacement (HR 2.14, 95% CI 1.58–2.88) surgery. Among the 11,794 FDRs (patients excluded), we found no increased risk of any of the joint morbidities.

Patients with GH, but not their FDRs, are at increased risk of arthropathies, including the need for joint replacement surgery.

To evaluate the impact of 2 magnetic resonance imaging (MRI) sequences on cartilage defect assessment in knee osteoarthritis (OA) patients and the sensitivity to change over time comparing cartilage defect (semiquantitative) with cartilage volume loss (quantitative) methods.

Gradient-echo (GRE) and intermediate-weighted fast spin-echo (IW-FSE) sequences were compared. Knee OA MRIs were from two 2-year studies (cohort 1, n = 55; cohort 2, n = 143). For both cohorts, a GRE sequence was used and patients in cohort 1 underwent an additional IW-FSE sequence. Cohort 2 included patients from a previous trial. Cartilage defects and cartilage volume were evaluated.

The cartilage defect assessment provided consistently significantly higher scores in IW-FSE than in GRE sequences at baseline and 2 years. However, there was no difference in the change at 2 years between the sequences. The standardized response mean (SRM) for change did not show a difference between the 2 sequences, but was consistently higher (2–2.5-fold) for the quantitative method. The cartilage defect score change between the 2 treatment groups revealed a trend toward significance only in the medial tibial plateau, whereas the change in cartilage volume loss demonstrated a significant difference in the global knee, global femur, lateral femur, and lateral compartment. The SRMs for the treatment groups combined were markedly higher for cartilage volume loss than for the defect scoring by 4.3- to 6.0-fold.

The direct comparison between GRE and IW-FSE sequences did not suggest superior sensitivity to cartilage defect change over time of one sequence over the other. Interestingly, the quantitative cartilage volume assessment was more sensitive than the semiquantitative scoring in the detection of treatment effect on OA cartilage changes.

Discordance between having pain and radiologic osteoarthritis (OA) is a well-established fact. It is suggested that this particularly applies to the less severe grades of OA. However, some people with a Kellgren/Lawrence (K/L) grade of 3 or 4 for OA are without pain. This study aimed to identify factors and differences in the factors associated with pain in persons with different grades of knee OA.

We stratified the knees of more than 5,000 participants of a population-based cohort study, the Rotterdam Study, based on the grade of knee OA. Multivariate generalized estimating equation analysis was used to analyze the association with knee pain. We tested several factors not directly related to structural damage of the knee.

As expected, an increasing percentage of participants did not report pain with decreasing severity of knee OA: 25.8% for K/L grade 3 or 4 and 84.5% for no knee OA. Being a woman, having widespread pain, reporting general health symptoms, familial OA, and morning stiffness are factors for knee pain, but not specific for a particular grade of radiographic knee OA. Depression and hip OA showed significant interactions with the grade of OA being a factor for knee pain in knees without OA (K/L grade 0), but not in knees with OA. In addition, increasing age is protective for reporting pain in general.

Several factors are associated with knee pain, but are not specific for a grade of radiographic knee OA. Two factors were associated with knee pain in the knee without signs of OA.

To estimate the incidence and lifetime risk of diagnosed symptomatic knee osteoarthritis (OA) and the age at diagnosis of knee OA based on self-reports in the US population.

We estimated the incidence of diagnosed symptomatic knee OA in the US by combining data on age-, sex-, and obesity-specific prevalence from the 2007–2008 National Health Interview Survey, with disease duration estimates derived from the Osteoarthritis Policy (OAPol) Model, a validated computer simulation model of knee OA. We used the OAPol Model to estimate the mean and median ages at diagnosis and lifetime risk.

The estimated incidence of diagnosed symptomatic knee OA was highest among adults ages 55–64 years, ranging from 0.37% per year for nonobese men to 1.02% per year for obese women. The estimated median age at knee OA diagnosis was 55 years. The estimated lifetime risk was 13.83%, ranging from 9.60% for nonobese men to 23.87% in obese women. Approximately 9.29% of the US population is diagnosed with symptomatic knee OA by age 60 years.

The diagnosis of symptomatic knee OA occurs relatively early in life, suggesting that prevention programs should be offered relatively early in the life course. Further research is needed to understand the future burden of health care utilization resulting from earlier diagnosis of knee OA.

An annual assessment of cardiovascular (CV) risk factors in rheumatoid arthritis (RA) is recommended, but its practical modalities have not been determined. The objective was to assess the feasibility and usefulness of a standardized CV risk assessment in RA, performed by rheumatologists during outpatient clinics.

We used a cross-sectional design within a network of rheumatologists. Each rheumatologist included 5 consecutive unselected patients with definite RA. Data collection included standardized assessment of CV risk factors: blood pressure, interpretation of glycemia and of lipid levels, and calculation of the Framingham CV risk score. Outcome criteria included feasibility (missing data and time taken to assess the patients) and usefulness (the CV risk assessment was considered useful if at least 1 modifiable and previously unknown CV risk factor was evidenced).

Twenty-two rheumatologists (77% in office-based practice) assessed 110 RA patients. The mean ± SD age was 57 ± 10 years, and the mean ± SD RA duration was 11 ± 9 years; 50 patients (45%) were treated with biologic agents, and 76% were women. Regarding feasibility, missing data were most frequent for glycemia (27% of patients) and cholesterolemia (14% of patients). The mean ± SD duration of the CV risk assessment was 15 ± 5 minutes. The CV risk assessment was considered useful in 33 patients (30%), evidencing dyslipidemia (15% of patients) or high blood pressure (9% of patients) as the most frequently previously unknown CV risk factor.

The assessment of CV risk factors is feasible, but labor intensive, during an outpatient rheumatology clinic. This assessment identified modifiable CV risk factors in 30% of the patients. These results suggest that RA patients are not sufficiently assessed and treated for CV risk factors.

To evaluate the impact of concomitant methotrexate (MTX) on subcutaneous (SC) abatacept immunogenicity, and to assess safety and efficacy.

This phase III, open-label study had a 4-month short-term (ST) period and an ongoing long-term extension (LTE) period. Rheumatoid arthritis patients were stratified to receive SC abatacept (125 mg/week) with (combination) or without MTX (monotherapy), with no intravenous loading dose; patients receiving monotherapy could add MTX in the LTE period. Immunogenicity (percentage of anti-abatacept antibody–positive patients) was assessed. ST and LTE period data are reported, including efficacy through LTE month 14 and safety through LTE month 20.

Ninety-six of 100 enrolled patients completed the ST period; 3.9% (combination) and 4.1% of patients (monotherapy) developed transient immunogenicity, and no patients were antibody positive at month 4. Serious adverse events (SAEs) were reported in 3.9% (combination) and 6.1% of patients (monotherapy); 5.9% (combination) and 8.2% of patients (monotherapy) experienced SC injection reactions, and all were mild in intensity. Mean 28-joint Disease Activity Score (DAS28) changes were −1.67 (95% confidence interval [95% CI] −2.06, −1.28; combination) and −1.94 (95% CI −2.46, −1.42; monotherapy) at month 4. Ninety patients entered and were treated in the LTE period; 83.3% (75 of 90) remained ongoing at month 24. One LTE-treated patient (1.1%) developed immunogenicity, 14.4% of patients experienced SAEs, and no SC injection reactions were reported. For patients entering the LTE period, mean DAS28 changes from baseline were −1.84 (95% CI −2.23, −1.34; combination) and −2.86 (95% CI −3.46, −2.27; monotherapy) at month 18.

SC abatacept did not elicit immunogenicity associated with loss of safety or efficacy, either with or without MTX.

To analyze prednisone treatment from 1980–2004 in 308 patients with rheumatoid arthritis (RA), including 75 monitored over 4–8 years and 73 monitored over >8 years, for initial dose, long-term doses and effectiveness, and adverse events.

A database of all patients of a single rheumatologist included medications and Multidimensional Health Assessment Questionnaire (MDHAQ) scores at each visit. Proportions of patients whose initial prednisone dosages were >5, 5, or <5 mg/day were computed in 5-year periods: 1980–1984, 1985–1989, 1990–1994, 1995–1999, and 2000–2004. Mean changes in MDHAQ function, pain, and Routine Assessment of Patient Index Data 3 (RAPID3) scores were compared in patients treated with <5 versus ≥5 mg/day of prednisone; scores and adverse events were analyzed in quartiles by treatment duration of ≤1, 1.1–4, 4.1–8, and >8 years.

In the respective 5-year periods, the mean initial prednisone dosages were 10.3, 6.5, 5.1, 4.1, and 3.6 mg/day, with >5 mg/day in 49%, 16%, 7%, 7%, and 3% of patients, 5 mg/day in 51%, 80%, 70%, 26%, and 10% of patients, and <5 mg/day in 0%, 4%, 23%, 67%, and 86% of patients. Most patients received early concomitant methotrexate after 1990, and prednisone <5 mg/day was maintained indefinitely. Patients treated with prednisone ≥5 mg/day had poorer clinical status as baseline and followup. MDHAQ scores improved similarly in patients treated with <5 or ≥5 mg/day. Primary adverse events were skin thinning and bruising. New hypertension, diabetes mellitus, and cataracts occurred in <10% of all patients, and <13% of those treated longer than 8 years.

The data suggest that many patients with RA might be treated effectively with initial and long-term prednisone <5 mg/day, although further research and observational data are needed to characterize more fully effectiveness and safety.

To determine the incidence of falls and to investigate the consequences of falls in adults with rheumatoid arthritis (RA).

A total of 559 community-dwelling adults with RA, ages 18–88 years (mean age 62 years, 69% women), participated in this prospective cohort study. After a detailed clinical assessment, patients were followed for 1 year, using monthly falls calendars and followup telephone calls. Followup took place in the participant's usual place of residence in the Northwest of England. Outcome measures included fall occurrence, reason for fall, type and severity of injuries, fractures, fall location, lie-times, use of health services, and functional ability.

A total of 535 participants followed for 1 year had a total of 598 falls. Of these participants, 36.4% (95% confidence interval 32%–41%) reported falling during the 1-year followup period, with an incidence rate of 1,313 per 1,000 person-years at risk or 1.11 falls per person. Age and sex were not associated with falls. More than one-third of the falls were reportedly caused by hips, knees, or ankle joints “giving way.” More than half of all the falls resulted in moderate injuries, including head injuries (n = 27) and fractures (n = 26). Treatment by general practitioners or other health professionals was required for 15.0% of falls, and emergency services were required for 8.8% of falls.

These results indicate that adults with RA are at high risk of falls and fall-related injuries, fractures, and head injuries. Strategies to prevent falls in adults with RA must be prioritized to reduce falls, fall-related injuries, and fractures.

Systemic juvenile idiopathic arthritis (JIA) is characterized by fevers, rash, and arthritis, for which interleukin-1 (IL-1) and IL-6 inhibitors appear to be effective treatments. Pulmonary arterial hypertension (PAH), interstitial lung disease (ILD), and alveolar proteinosis (AP) have recently been reported with increased frequency in systemic JIA patients. Our aim was to characterize and compare systemic JIA patients with these complications to a larger cohort of systemic JIA patients.

Systemic JIA patients who developed PAH, ILD, and/or AP were identified through an electronic Listserv and their demographic, systemic JIA, and pulmonary disease characteristics as well as their medication exposure information were collected. Patients with these features were compared to a cohort of systemic JIA patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry.

The patients (n = 25) were significantly (P < 0.05) more likely than the CARRA registry cohort (n = 389) to be female; have more systemic features; and have been exposed to an IL-1 inhibitor, tocilizumab, corticosteroids, intravenous immunoglobulin, cyclosporine, and cyclophosphamide. Twenty patients (80%) were diagnosed with pulmonary disease after 2004. Twenty patients (80%) had macrophage activation syndrome (MAS) during their disease course and 15 patients (60%) had MAS at pulmonary diagnosis. Sixteen patients had PAH, 5 had AP, and 7 had ILD. Seventeen patients (68%) were taking or recently discontinued (<1 month) a biologic agent at pulmonary symptom onset; 12 patients (48%) were taking anti–IL-1 therapy (primarily anakinra). Seventeen patients (68%) died at a mean of 10.2 months from the diagnosis of pulmonary complications.

PAH, AP, and ILD are underrecognized complications of systemic JIA that are frequently fatal. These complications may be the result of severe uncontrolled systemic disease activity and may be influenced by medication exposure.

Item 9 of the Patient Health Questionnaire-9 (PHQ-9), which inquires about both passive thoughts of death and active ideas of self-harm, has been used to assess suicide risk in arthritis. The objectives of this study were 1) to determine the proportion of systemic sclerosis (SSc; scleroderma) patients who responded “yes” to item 9 who endorsed active suicidal ideation in response to more direct questions during a structured clinical interview, and 2) to report whether the PHQ-8, which does not include item 9 from the PHQ-9, performs similarly to the PHQ-9.

Patients were recruited from the Canadian Scleroderma Research Group Registry. The PHQ-9 and Composite International Diagnostic Interview (CIDI) depression module were administered during a phone interview. Scores on the PHQ-8 were calculated by removing item 9 from the PHQ-9. Item 9 responses were compared to suicidal ideation and intent in the last year based on the CIDI. Scores on the PHQ-8 and PHQ-9 were compared using Pearson's correlations.

There were 345 patients interviewed, of whom 31 (9.0%) endorsed item 9 of the PHQ-9. Of those, based on the CIDI, 14 (45.2%) had passive thoughts of suicide or death. Only 1 patient (3.2%) had thoughts about suicide in some detail at any point in the last 12 months. The correlation between PHQ-9 and PHQ-8 scores was 0.998.

Item 9 appears to identify many patients who do not report active suicidal ideation. The PHQ-8 may be a better option for assessment of depressive symptoms than the PHQ-9 in patients with SSc.

Azathioprine (AZA) is recognized among immunosuppressive medications as relatively safe during pregnancy for women with systemic lupus erythematosus (SLE) requiring aggressive treatment. This pilot study aimed to determine whether SLE therapy during pregnancy was associated with developmental delays in offspring.

This cohort study included SLE patients with at least one live birth postdiagnosis. Medical histories were obtained via interviews and chart review. Multiple logistic regression was used to examine associations between SLE therapy during pregnancy and maternal report of special educational (SE) requirements (as proxy for developmental delays) among offspring. Propensity scoring (incorporating corticosteroid use, lupus flare, and lupus nephritis) was used to account for disease severity.

Of 60 eligible offspring from 38 mothers, 15 required SE services, the most common indication for which was speech delay. Seven (54%) of the 13 children with in utero AZA exposure utilized SE services versus 8 (17%) of 47 nonexposed children (P < 0.01). After adjustment for pregnancy duration, small for gestational age, propensity score, maternal education level, and antiphospholipid antibody syndrome, AZA was significantly associated with SE utilization occurring from age 2 years onward (odds ratio 6.6, 95% confidence interval 1.0–43.3), and bordered on significance for utilization at any age or age <2 years.

AZA exposure during SLE pregnancy was independently associated with increased SE utilization in offspring, after controlling for confounders. Further research is indicated to fully characterize developmental outcomes among offspring with in utero AZA exposure. Vigilance and early interventions for suspected developmental delays among exposed offspring may be warranted.

To determine the frequency and reproducibility of standardized photoprovocation in patients with cutaneous lupus erythematosus (CLE) and report our long-term experience.

Photoprovocation using a standardized protocol was evaluated retrospectively in 566 patients. A diagnosis of CLE was clinically and/or histologically confirmed in 431 patients, and 315 patients with polymorphic light eruption (PLE) were additionally included as controls. Data were statistically analyzed using an SPSS database.

A total of 61.7% of the 431 CLE patients exhibited a positive photoprovocation, with a significantly longer latency period for the development of skin lesions after ultraviolet (UV) A and/or UVB irradiation than PLE patients (P < 0.001). The frequency of positive photoprovocation varied among the CLE subtypes, and intermittent CLE was the most photosensitive disease entity (74.8%). Subsequent photoprovocation in 35 patients demonstrated that CLE patients with an initial positive result exhibited a significantly higher frequency of a positive photoprovocation at a later time point (P = 0.013). However, an initial positive photoprovocation did not definitively predict a positive reaction at a later time point. Moreover, patient history of photosensitivity was not a predictor for the photoprovocation outcome.

Standardized photoprovocation is a useful tool to reproducibly induce skin lesions and objectively evaluate photosensitivity in patients with CLE. These data further suggest that the reaction to UV light may change during the course of this heterogeneous disease and that photosensitivity should not be excluded in patients with a negative history of photosensitivity.

To evaluate fibromyalgia in the general population with emphasis on prevalence, dimensionality, and somatic symptom severity.

We studied 2,445 subjects randomly selected from the German general population in 2012 using the American College of Rheumatology 2010 preliminary diagnostic criteria for fibromyalgia, as modified for survey research, and the polysymptomatic distress scale (PSD). Anxiety, depression, and somatic symptom severity were assessed with the Patient Health Questionnaire (PHQ) series, and measures of symptoms and quality of life were assessed with the European Organization for Research and Treatment of Cancer questionnaire.

The prevalence of fibromyalgia was 2.1% (95% confidence interval [95% CI] 1.6, 2.7), with 2.4% (95% CI 1.5, 3.2) in women and 1.8% (95% CI 1.1, 2.6) in men, but the difference was not statistically significant. Prevalence rose with age. Fibromyalgia subjects had markedly abnormal scores for all covariates. We found smooth, nondisordered relationships between PSD and all predictors, providing additional evidence against the hypothesis that fibromyalgia is a discrete disorder and in support of a dimensional or spectrum disorder. There was a strong correlation (r = 0.790) between the PSD and the PHQ somatic symptom severity scale; 38.5% of persons with fibromyalgia satisfied the proposed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for a physical symptom disorder.

The modified 2010 diagnostic criteria do not result in high levels of fibromyalgia. PSD and fibromyalgia are strongly related to somatic symptom severity. There is evidence in support of fibromyalgia as a dimensional or continuum disorder. This has important ramifications for neurobiologic and epidemiology research, and for clinical diagnosis, treatment, and ascertainment of disability.

To estimate and compare the prevalence of fibromyalgia by 2 different methods in Olmsted County, Minnesota.

The first method was a retrospective review of medical records of potential cases of fibromyalgia in Olmsted County using the Rochester Epidemiology Project (from January 1, 2005, to December 31, 2009) to estimate the prevalence of diagnosed fibromyalgia in clinical practice. The second method was a random survey of adults in Olmsted County using the fibromyalgia research survey criteria to estimate the percentage of responders who met the fibromyalgia research survey criteria.

Of the 3,410 potential patients identified by the first method, 1,115 had a fibromyalgia diagnosis documented in the medical record by a health care provider. The age- and sex-adjusted prevalence of diagnosed fibromyalgia by this method was 1.1%. By the second method, of the 2,994 people who received the survey by mail, 830 (27.6%) responded and 44 (5.3%) met the fibromyalgia research survey criteria. The age- and sex-adjusted prevalence of fibromyalgia in the general population of Olmsted County by this method was estimated at 6.4%.

To the best of our knowledge, this is the first report of the rate at which fibromyalgia is being diagnosed in a community. This is also the first report of prevalence as assessed by the fibromyalgia research survey criteria. Our results suggest that patients, particularly men, who meet the fibromyalgia research survey criteria are unlikely to have been given a diagnosis of fibromyalgia.

To evaluate the frequency of metabolic syndrome in dermatomyositis (DM) patients and to analyze the possible association of metabolic syndrome with traditional cardiovascular disease (CVD) risk factors and DM-related clinical and laboratory features.

The present cross-sectional single-center study included 84 DM patients and 105 healthy controls. Metabolic syndrome was diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III.

The median age was similar in both the DM and control groups (41.5 and 42.0 years, respectively; P = 0.378), with a comparable predominance of women (P = 0.904) and white race (P = 0.623). The DM patients had a higher prevalence of metabolic syndrome (41.7% versus 7.0%; P < 0.001), diabetes mellitus (17.9% versus 1.0%; P < 0.001), stroke (4.8% versus 0%; P = 0.024), and family history of CVD (23.8% versus 8.6%; P = 0.004). However, the frequency of sedentarism, hypothyroidism, smoking, and alcohol intake was similar in both groups (P > 0.05). Further analysis of the DM patients with (n = 35) and without (n = 49) metabolic syndrome revealed that the patients with this complication were older (mean ± SD age 50.0 ± 14.5 years versus 40.9 ± 14.6 years; P = 0.006) and had a similar disease duration (P = 0.925) and higher prevalence of systemic arterial hypertension prior to the onset of disease symptoms (54.3% versus 10.2%; P < 0.001). In a multivariate analysis, only hypertension diagnosed prior to the disease was associated with metabolic syndrome (odds ratio 10.47 [95% confidence interval 2.62–44.81]).

Metabolic syndrome is highly prevalent in DM, and prior hypertension seems to be a major determinant of its development, while disease- and therapy-related factors do not appear to play a relevant role.

To assess the outcome of interstitial lung disease (ILD) in anti–Jo-1 patients with antisynthetase syndrome, determine predictive variables of ILD deterioration in these patients, and compare features of anti–Jo-1 patients with and without ILD.

Ninety-one anti–Jo-1 patients were identified by medical records search in 4 medical centers. All of these patients had undergone pulmonary function tests (PFTs) and high-resolution computed tomography (HRCT) scans.

Sixty-six patients (72.5%) had ILD. Patients could be divided into 3 groups according to their presenting lung manifestations: acute onset of lung disease (n = 12), progressive onset of lung signs (n = 35), and asymptomatic patients exhibiting abnormalities consistent with ILD on PFTs and HRCT scans (n = 19). Sixteen patients had resolution of ILD; 39 and 11 patients experienced improvement and deterioration of ILD, respectively. ILD led to decreased functional status, since 29.8% of patients exhibited a marked reduction of activities due to ILD and 13.6% had respiratory insufficiency requiring oxygen therapy; 5 of 6 patients died due to ILD complications. Predictive parameters of ILD deterioration were HRCT scan pattern of usual interstitial pneumonia, respiratory muscle involvement, and age ≥55 years. Furthermore, anti–Jo-1 patients with ILD, compared with those without, more frequently exhibited mechanic's hands and lower creatine kinase levels.

Our findings confirm that ILD is a frequent complication in anti–Jo-1 patients, resulting in high morbidity. We suggest that patients with predictive factors of ILD deterioration may require more aggressive therapy. Finally, anti–Jo-1 patients with ILD, compared with those without, may exhibit a particular clinical phenotype.

Vertebral fractures are associated with higher morbidity and mortality. Since 70% of vertebral fractures are clinically silent, a radiologic image of the spine has to be acquired for the diagnosis. The aim of this study was to compare the performance of Vertebral Fracture Assessment (VFA) by dual x-ray absorptiometry (DXA) with radiographs to identify vertebral fractures in community-dwelling older adults.

A total of 429 older adults (ages ≥65 years) were enrolled in this cohort. VFA by DXA measurements were evaluated by 2 expert rheumatologists by consensus, and spine radiographs were analyzed according to the semiquantitative method by an expert radiologist. The correlation between VFA and spine radiographs to identify vertebral fractures was analyzed by kappa scores.

The prevalence of vertebral fractures in VFA and radiographs was 29.1% and 29.4%, respectively (P = 0.99). The frequency of unavailable vertebrae was significantly lower in spinal radiographs than in VFA (0.9% and 5.6%, respectively; P < 0.001), particularly in T4–T6. According to VFA, 5,013 vertebrae (96%) were identified as normal and 144 (2.7%) had grade 1, 58 (1.1%) had grade 2, and 12 (0.2%) had grade 3 fractures. The sensitivity of VFA was 72.9% and the specificity was 99.1% to identify vertebral fractures. The sensitivity increased to 92% and the specificity increased to 99.9% when excluding grade 1 deformities. A good correlation between VFA and radiographs (κ = 0.74) was observed, and the exclusion of grade 1 resulted in even better agreement (κ = 0.84).

In community-dwelling older adults, VFA and radiographs had comparable performances in identifying vertebral fractures, particularly if mild deformities are excluded. Therefore, this methodology is a feasible and promising alternative to improve the management of patients with a high risk of osteoporotic fractures.

Primary Sjögren's syndrome (SS) is associated with an increased risk of non-Hodgkin's lymphoma (NHL), but the reported prevalence and risk vary considerably. The objective of this study was to determine the risk of NHL in a well-defined population-based primary SS cohort in Norway.

The authors examined all patients fulfilling the American–European Consensus Group criteria for primary SS from 2 Norwegian counties and compared the data to the Cancer Registry of Norway to identify the primary SS patients who had lymphoma. In addition, lymphoma patient files from the same period were reviewed for undiagnosed primary SS to ensure the quality of registry data.

As of July 1, 2009, 443 living subjects with primary SS were identified in an area with 896,840 inhabitants, which is 18.6% of the total population of Norway. Seven cases of NHL (1.6%) were found during a total followup of 3,813 person-years, resulting in a standardized incidence ratio of 9.0 (95% confidence interval 7.1–26.3) for NHL in primary SS patients.

The risk of NHL in patients with primary SS in Norway is increased 9 times compared with the general population. This is in accordance with recent studies, and the quality and completeness of the registries and strict use of diagnostic criteria support the validity of the results.

Anakinra is effective in adult-onset Still's disease (AOSD) in the short term, but little is known regarding its efficacy over the long term. Our objective was to assess the long-term efficacy and safety of anakinra in AOSD.

A nationwide survey was conducted between 2009 and 2010 to identify AOSD patients treated with anakinra. Collected data consisted of disease characteristics at diagnosis and at medication onset; anakinra efficacy, safety, and dose adaptation; and reasons for discontinuation, if applicable.

The study included 28 AOSD patients, with a mean age of 40.3 years and a mean disease duration at the start of anakinra of 9.3 years. All patients had previously failed to respond to steroids and disease-modifying antirheumatic drugs. All patients responded to anakinra, with a rapid and sustained decrease in steroid doses. At the last followup (mean 23 months), 16 patients were still being treated with anakinra: 4 had a partial response and 12 were in complete remission. Twelve patients had discontinued anakinra: 2 due to an insufficient response, 4 due to an AOSD flare after a period of complete remission, 2 due to side effects, and 1 due to a desire for pregnancy. In 3 patients, the drug discontinuation was possible because they achieved complete remission. Six additional patients experienced anakinra dose tapering, with sustained remission in 2 and relapse in the others. Anakinra was well tolerated and adverse events were rated as mild.

Anakinra was consistently efficacious in AOSD and displayed good therapeutic maintenance. Anakinra dose tapering or discontinuation was associated with relapse in half of the patients.

A significant subset of systemic lupus erythematosus (SLE) patients exhibit chronic tachycardia (CT) of unknown significance. We postulated that CT is a marker of lupus activity and severity.

A cross-sectional database at the University of Chicago recorded disease activity, damage, disease manifestations, pain, anxiety, and physical function (PF). CT was defined as a heart rate of ≥95 beats per minute in at least 3 out of 4 sequential visits. Demographic, disease-specific, and self-reported symptoms were compared between groups with and without tachycardia.

Of the 243 subjects analyzed, 14.8% had CT. On univariate analysis, CT was associated with younger age at the time of enrollment (P = 0.004), number of hospitalizations adjusted for years of SLE (P = 0.001), current prednisone dose (P < 0.0001), history of serositis (P = 0.03), anxiety score (P = 0.004), and poor PF (P = 0.0017). All domains of the Short Form 36 (SF-36) health survey correlated strongly with CT, but on multivariate regression this correlation appeared to be driven by poor PF. On multivariate regression, the Systemic Lupus Erythematosus Disease Activity Index score (P = 0.03), younger age (P = 0.04), and poor PF by the SF-36 domain (P = 0.006) were independently correlated with CT, and anxiety trait and hemoglobin both trended closely to significant association (P = 0.08 for both).

CT is prevalent in SLE and is a clinically relevant physical finding. It implies greater lupus activity and physical frailty. Univariate association with serositis raises the possibility of subclinical serositis or pancarditis. Further study to elucidate the cardiopulmonary status of SLE patients with unexplained CT is planned.