1. Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials
- Author
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Bruce, Ian N, Furie, Richard A, Morand, Eric F, Manzi, Susan, Tanaka, Yoshiya, Kalunian, Kenneth C, Merrill, Joan T, Puzio, Patricia, Maho, Emmanuelle, Kleoudis, Christi, Albulescu, Marius, Hultquist, Micki, and Tummala, Raj
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Lupus ,Clinical Research ,Autoimmune Disease ,Clinical Trials and Supportive Activities ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Inflammatory and immune system ,Alprostadil ,Antibodies ,Monoclonal ,Humanized ,Glucocorticoids ,Humans ,Lupus Erythematosus ,Systemic ,Severity of Illness Index ,Treatment Outcome ,Autoimmune Diseases ,Biological Therapy ,Immunology ,Public Health and Health Services ,Arthritis & Rheumatology ,Clinical sciences - Abstract
ObjectivesIn the anifrolumab systemic lupus erythematosus (SLE) trial programme, there was one trial (TULIP-1) in which BILAG-based Composite Lupus Assessment (BICLA) responses favoured anifrolumab over placebo, but the SLE Responder Index (SRI(4)) treatment difference was not significant. We investigated the degree of concordance between BICLA and SRI(4) across anifrolumab trials in order to better understand drivers of discrepant SLE trial results.MethodsTULIP-1, TULIP-2 (both phase 3) and MUSE (phase 2b) were randomised, 52-week trials of intravenous anifrolumab (300 mg every 4 weeks, 48 weeks; TULIP-1/TULIP-2: n=180; MUSE: n=99) or placebo (TULIP-1: n=184, TULIP-2: n=182; MUSE: n=102). Week 52 BICLA and SRI(4) outcomes were assessed for each patient.ResultsMost patients (78%-85%) had concordant BICLA and SRI(4) outcomes (Cohen's Kappa 0.6-0.7, nominal p
- Published
- 2022