Response and remission criteria for clinical trials in lupus— what can we learn from other diseases?

Liang MH , Socher SA , Roberts WN , Esdaile JM . Measurement of systemic lupus erythematosus activity in clinical research . Arthritis Rheum 1988; 31: 817–825 .

Bombardier C , Gladman DD , Urowitz MB , Caron D , Chang CH and The Committee on Prognosis Studies in SLE . The development and validation of the SLE disease activity index (SLEDAI) . Arthritis Rheum 1992; 35: 630–640 .

Symmons DP , Coppock JS , Bacon PA et al. Development and assessment of a computerized index of clinical activity in systemic lupus erythematosus . Q J Med 1988; 69: 927–937 .

Vitali C , Bencivelli W , Isenberg DA et al. Disease activity in systemic lupus erythematosus: report of the Consensus Study Group of the European Workshop for Rheumatology Research: II. Identification of the variables indicative of disease activity and their use in the development of an activity score . Clin Exp Rheumatol 1992; 10: 541–547 .

Stoll T , Seifert B , Isenberg DA . SLICC/ACR damage index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus . Br J Rheumatol; 1996 35: 248–254 .

Smolen JS , Strand V , Cardiel M 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: 504–507 .

Roberts RS . Pooled outcome measures in arthritis: The pros and cons . J Rheumatol 1993; 20: 566–567 .

Felson DT , Anderson JJ , Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis . Arthritis Rheum 1993; 36: 729–740 .

WHO Handbook of Reporting Results of Cancer Treatment. WHO Offset Publication, Geneva , 1979, No. 48.

Yates J , Glidewell O , Wiernik P et al. Cytosine arabinoside with daunorubicin or adriamycin for therapy of acute myelocytic leukemia: a CALGB study . Blood 1982; 60: 454–462 .

Martin-Suarez IM , D'Cruz D , Mansoor M , Fernandes AP , Khamashta MA , Hughes GRV . Immunosuppressive treatment in severe connective tissue diseases: effect of low dose intravenous cyclophosphamide . Ann Rheum Dis 1997; 56: 481–487 .

Snowden JA , Patton WN . O'Donnell JL , Hannah EE , Hart DNJ . Prolonged remission of longstanding systemic lupus erythematosus after autologous bone marrow transplant for non-Hodgkin's lymphoma . Bone Marrow Transplant 1997; 19: 1247–1250 .

Liu TF , Jones BM . Impaired production of IL-12 in systemic lupus erythematosus. I. Excessive production of IL-10 suppresses production of IL-12 by monocytes . Cytokine 1998; 10: 140–147 .

Gerez L , Shkolnik T , Hirschmann O , Lorber M , Arad G , Kaempfer R . Hyperinducible expression of the interferon-gamma gene and its suppression in systemic lupus erythematosus . Clin Exp Immunol 1997; 109: 296–303 .

Boumpas DT , Barlow JE . Outcome criteria for lupus nephritis trials: A critical overview . Lupus 1998; 7: 622–629 .

Austin HA , Klippel JH , Barlow JE et al. Therapy of lupus nephritis; controlled trial of prednisone and cytotoxic drugs . N Engl J Med 1986; 314: 614–619 .

Esdaile JM , Abrahamowicz M , Mackenzie T , Hayslett JP , Kashgarian M . The time-dependence of long-term prediction in lupus nephritis . Arthritis Rheum 1992; 37: 359–368 .

Montgomery SA , Asberg M . A new depression scale designed to be sensitive to change . Br J Psychiatry 1979; 134: 382–389 .

Amminger GP , Resch F , Mutschlechner R , Friedrich MH , Ernst E . Premorbid adjustment and remission of positive symptoms in first episode psychosis . Eur Child & Adolescent Psychiatry 1997; 6: 212–218 .

Petri M , Barr SG , Zonana-Nach A , Magder L . Measures of disease activity, damage, and health status: The Hopkins lupus cohort experience . J Rheumatol 1999; 26: 502–503 .

Investigator's Handbook. A Manual for Participants in Clinical Trials in Investigational Agents. Cancer Therapy Evaluation Program. Division of Cancer Treatment, National Cancer Institute, Bethesda , 1993.

Furst D et al. Proposed rheumatology common toxicity criteria (in preparation).

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: 490–497 .

Liang MH , Fortin PR . Response criteria for clinical trials in systemic lupus erythematosus . Lupus 1995; 4: 336–338 .