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Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens

Authors


  • Trial registration: This trial is registered with ClincialTrials.gov, number NCT00245960.

  • Conflict of interest
    Dr Gniadecki has been a paid lecturer for Wyeth, Schering-Plough, Abbott Laboratories, Janssen-Cilag and a member of the Danish National Advisory Boards for Wyeth and Schering-Plough. All other authors are employees or former employees of Wyeth/Pfizer Inc.

  • Funding sources
    Wyeth Research, which was acquired by Pfizer in October 2009, sponsored this clinical trial and was responsible for the collection and analysis of data. The authors and the sponsor were involved in the study design, interpretation of data, manuscript preparation and decision to publish. All statistical analyses were done by the Global Biostatistics and Programming and Global Health Outcomes Assessment Departments of Wyeth Research. The corresponding author had full access to all the relevant data in the study and had final responsibility for the decision to submit the report for publication.

Correspondence: R. Gniadecki. E-mail:r.gniadecki@gmail.com

Abstract

Background  Moderate/severe psoriasis combined with psoriatic arthritis (PsA) impairs health-related quality of life (QoL). Etanercept, a fully human tumour necrosis factor-α receptor fusion protein, is approved for treatment of both diseases.

Objective  To compare patient-reported health outcomes (PROs) of two etanercept regimens in patients with moderate/severe psoriasis and PsA.

Methods  In this randomized, double-blind, multicenter study, participants received etanercept 50 mg twice weekly (BIW; n = 379) or 50 mg weekly (QW; n = 373) for 12 weeks and open-label etanercept 50 mg QW for 12 additional weeks. PROs included: the EuroQOL-5D (EQ-5D), which measures general health status and consists of the utility index measuring five dimensions of health, and a visual analogue scale (VAS) allowing patients to assess health status; the Dermatology Life Quality Index (DLQI), which measures the impact of skin disease on QoL; the Health Assessment Questionnaire-Disability Index (HAQ-DI), an assessment of physical function; the Hospital Anxiety and Depression Scale (HADS), which screens for anxiety and depression symptoms; and individual questions on general health, disease activity, fatigue, itching, joint pain and morning stiffness.

Results  At baseline, patients reported QoL worse than that seen in many chronic medical conditions. Significant within-group improvements in each PRO occurred from baseline to Week 12 (P < 0.001) in both groups and were maintained at Week 24; DLQI, EQ-5D, HAQ-DI and self assessments improved significantly (P < 0.001) from baseline as early as Week 3. At Week 12, but not Week 24, improvement in DLQI, itching and psoriasis activity was greater in the BIW arm (P ≤ 0.004). Improvements in other PROs were always similar between groups.

Conclusions  Greater improvements in PROs specific to skin disorders were seen with etanercept BIW than QW at Week 12, but not at Week 24. Both etanercept regimens led to sustained PRO improvements, starting as early as Week 3.

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