• 1
    Rahman A, Isenberg DA. Systemic lupus erythematosus. N Engl J Med 2008; 358: 92939.
  • 2
    American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Guidelines for referral and management of systemic lupus erythematosus in adults. Arthritis Rheum 1999; 42: 178596.
  • 3
    Strand V. Lessons learned from clinical trials in SLE. Autoimmun Rev 2007; 6: 20914.
  • 4
    Food and Drug Administration. Guidance for industry systemic lupus erythematosus: developing drugs for treatment. 2005. URL:
  • 5
    Bertsias G, Gordon C, Boumpas D. Clinical trials in systemic lupus erythematosus (SLE): lessons from the past as we proceed to the future. The EULAR recommendations for the management of SLE and the use of end-points in clinical trials. Lupus 2008; 17: 43742.
  • 6
    Griffiths B, Mosca M, Gordon C. Assessment of patients with systemic lupus erythematosus and the use of lupus disease activity indices. Best Pract Res Clin Rheumatol 2005; 19: 685708.
  • 7
    Strand V, Gladman D, Isenberg D, Petri M, Smolen J, Tugwell P. Outcome measures to be used in clinical trials in systemic lupus erythematosus. J Rheumatol 1999; 26: 4907.
  • 8
    Smolen JS, Strand V, Cardiel M, Edworthy S, Furst D, Gladman D, et al. Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: consensus on a preliminary core set of outcome domains. J Rheumatol 1999; 26: 5047.
  • 9
    Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH, and the Committee on Prognosis Studies in SLE. Derivation of the SLEDAI: a disease activity index for lupus patients. Arthritis Rheum 1992; 35: 63040.
  • 10
    Petri M, Kim MY, Kalunian KC, Grossman J, Hahn BH, Sammaritano LR, et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005; 353: 25508.
  • 11
    Hay EM, Bacon PA, Gordon C, Isenberg DA, Maddison P, Snaith ML, et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. Q J Med 1993; 86: 44758.
  • 12
    Stoll T, Stucki G, Malik J, Pyke S, Isenberg DA. Further validation of the BILAG disease activity index in patients with systemic lupus erythematosus. Ann Rheum Dis 1996; 55: 75660.
  • 13
    Petri M, Buyon J, Kim M. Classification and definition of major flares in SLE clinical trials. Lupus 1999; 8: 68591.
  • 14
    Gordon C, Sutcliffe N, Skan J, Stoll T, Isenberg DA. Definition and treatment of lupus flares measured by the BILAG index. Rheumatology (Oxford) 2003; 42: 13729.
  • 15
    Gladman D, Ginzler E, Goldsmith C, Fortin P, Liang M, Urowitz M, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum 1996; 39: 3639.
  • 16
    Gladman DD, Goldsmith CH, Urowitz MB, Bacon P, Bombardier C, Isenberg D, et al. Crosscultural validation and reliability of 3 disease activity indices in systemic lupus erythematosus. J Rheumatol 1992; 19: 60811.
  • 17
    Ward MM, Marx AS, Barry NN. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. J Rheumatol 2000; 27: 66470.
  • 18
    Cook RJ, Gladman DD, Pericak D, Urowitz MB. Prediction of short term mortality in systemic lupus erythematosus with term dependent measures of disease activity. J Rheumatol 2000; 27: 18925.
  • 19
    Danowski A, Magder L, Petri M. Flares in lupus: Outcome Assessment Trial (FLOAT), a comparison between oral methylprednisolone and intramuscular triamcinolone. J Rheumatol 2006; 33: 5760.
  • 20
    Ibanez D, Gladman D, Urowitz M. Summarizing disease features over time. II. Variability measures of SLEDAI-2K. J Rheumatol 2007; 34: 33640.
  • 21
    Swaak AJ, van den Brink HG, Smeenk RJ, Manger K, Kalden JR, Tosi S, et al. Systemic lupus erythematosus: clinical features in patients with a disease duration of over 10 years, first evaluation. Rheumatology (Oxford) 1999; 38: 9538.
  • 22
    Isenberg DA, Gordon C. From BILAG to BLIPS: disease activity assessment in lupus past, present and future. Lupus 2000; 9: 6514.
  • 23
    Rahman P, Gladman DD, Urowitz MB, Hallett D, Tam LS. Early damage as measured by the SLICC/ACR damage index is a predictor of mortality in systemic lupus erythematosus. Lupus 2001; 10: 936.
  • 24
    Stoll T, Sutcliffe N, Mach J, Klaghofer R, Isenberg DA. Analysis of the relationship between disease activity and damage in patients with systemic lupus erythematosus: a 5-year prospective study. Rheumatology (Oxford) 2004; 43: 103944.
  • 25
    Moroni G, Doria A, Mosca M, Alberighi OD, Ferraccioli G, Todesco S, et al. A randomized pilot trial comparing cyclosporine and azathioprine for maintenance therapy in diffuse lupus nephritis over four years. Clin J Am Soc Nephrol 2006; 1: 92532.
  • 26
    Ong LM, Hooi LS, Lim TO, Goh BL, Ahmad G, Ghazalli R, et al. Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis. Nephrology (Carlton) 2005; 10: 50410.
  • 27
    Kalunian KC, Davis JC Jr, Merrill JT, Totoritis MC, Wofsy D, for the IDEC-131 Lupus Study Group. Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002; 46: 32518.
  • 28
    Petri MA, Mease PJ, Merrill JT, Lahita RG, Iannini MJ, Yocum DE, et al. Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus: results of a multicenter randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2004; 50: 285868.
  • 29
    Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD, and the LSP 394-90-09 Investigator Consortium. Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial. Arthritis Rheum 2008; 58: 247080.
  • 30
    Ginzler EM, Appel GB, Dooley MA, Isenberg DA, Jayne DR, Solomons N, et al. Mycophenolate mofetil and intravenous cyclophosphamide in the Aspreva lupus management study (ALMS): efficacy by racial group [abstract]. Arthritis Rheum 2007; 56 Suppl: L13.
  • 31
    Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, et al. Efficacy and safety of rituximab in patients with moderately to severely active systemic lupus erythematosus (SLE): results from the randomized, double blind phase II/III study EXPLORER [abstract]. Arthritis Rheum 2008; 58 Suppl: L12.
  • 32
    Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum 2009; 61: 116878.
  • 33
    Baker KP, Edwards BM, Main SH, Choi GH, Wager RE, Halpern WG, et al. Generation and characterization of LymphoStat-B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator. Arthritis Rheum 2003; 48: 325365.
  • 34
    Petri M, Stohl W, Chatham W, McCune WJ, Chevrier M, Ryel J, et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthritis Rheum 2008; 58: 24539.
  • 35
    Strand V, Crawford B. Improvement in health-related quality of life in patients with SLE following sustained reductions in anti-dsDNA antibodies. Exp Rev Pharmacoeconomics Outcome Res 2005; 5: 31726.
  • 36
    Thumboo J, Strand V. Health-related quality of life in patients with systemic lupus erythematosus: an update. Ann Acad Med Singapore 2007; 36: 11522.
  • 37
    Hochberg MC, for the Diagnostic and Therapeutic Criteria Committee of the American College of Rheumatology. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus [letter]. Arthritis Rheum 1997; 40: 1725.
  • 38
    Ware JE Jr, Gandek B. Overview of the SF-36 health survey and the International Quality of Life Assessment (IQOLA) project. J Clin Epidemiol 1998; 51: 90312.
  • 39
    Gladman DD, Urowitz MB, Kagal A, Hallett D. Accurately describing changes in disease activity in systemic lupus erythematosus. J Rheumatol 2000; 27: 3779.
  • 40
    Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol 1993; 20: 55760.
  • 41
    Buyon JP, Petri MA, Kim MY, Kalunian KC, Grossman J, Hahn BH, et al. The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: a randomized trial. Ann Intern Med 2005; 142: 95362.
  • 42
    Yee CS, Farewell V, Isenberg DA, Rahman A, Teh LS, Griffiths B, et al. British Isles Lupus Assessment Group 2004 index is valid for assessment of disease activity in systemic lupus erythematosus. Arthritis Rheum 2007; 56: 41139.
  • 43
    Yee C, Farewell V, Isenberg D, Rahman A, Teh L, Griffiths B, et al. BILAG-2004 index for assessment of SLE disease activity is sensitive to change [abstract]. Arthritis Rheum 2007; 56 Suppl: S226.
  • 44
    American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria. The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: measures of overall disease activity. Arthritis Rheum 2004; 50: 341826.
  • 45
    Wollaston SJ, Farewell VT, Isenberg DA, Gordon C, Merrill JT, Petri MA, et al. Defining response in systemic lupus erythematosus: a study by the Systemic Lupus International Collaborating Clinics group. J Rheumatol 2004; 31: 23904.
  • 46
    Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995; 38: 72735.
  • 47
    Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index: National Cooperative Crohn's Disease study. Gastroenterology 1976; 70: 43944.
  • 48
    Strand V, Crawford B, Petri M, Ramsey-Goldman R, Fernandez V, Zhong J, et al. Therapeutic responses reflecting a reduction in SELENA SLEDAI score are associated with a stabilization or improvement in health related quality of life (HRQOL) [abstract]. Arthritis Rheum 2006; 54 Suppl: S278.
  • 49
    Cambridge G, Isenberg DA, Edwards J, Leandro MJ, Migone TS, Teodorescu M, et al. B cell depletion therapy in systemic lupus erythematosus: relationships among serum B lymphocyte stimulator levels, autoantibody profile and clinical response. Ann Rheum Dis 2008; 67: 10116.
  • 50
    Stohl W, Chatham W, McKay J, Weisman M, Merrill J, Petri M, et al. Progressive normalization of autoantibody, immunoglobulin, and complement levels over 2.5 years of belimumab (fully human monoclonal antibody to BLyS) therapy in systemic lupus erythematosus (SLE) patients [abstract]. Arthritis Rheum 2007; 56 Suppl: S210.