POS0683 NOVEL STRINGENT OUTCOME MEASURES APPLIED TO THE PHASE 2 AND 3 ANIFROLUMAB TRIALS

Background: Patients with systemic lupus erythematosus (SLE) who received anifrolumab, a type I interferon receptor antibody, had greater BILAG–based Composite Lupus Assessment (BICLA) response rates vs placebo at Week (W)52 in the phase 2 MUSE 1 and 3 TULIP-1 TULIP-2 trials. receiving anifrolumab also fewer flares, more patients were able to taper glucocorticoids (GC) placebo. 1–3 Objectives: To evaluate treatment SLE from MUSE, TULIP-1, using stringent BICLA definitions, as well novel endpoint that requires dual Responder Index (SRI[4]) responses. Methods: ( NCT01438489 ), NCT02446912 NCT02446899 ) randomized, placebo-controlled, 52-week trials of intravenous (every 4 weeks for 48 weeks) moderate severe despite standard therapy. Sustained GC was defined ?7.5 mg/day ?10 baseline, or less than equal baseline dose <10 achieved by W40 sustained through W52. Response compared between 300 mg groups attained W52 taper; no flares after W12 (flare ?1 new BILAG-2004 A ?2 B scores prior visit); W12; an enhanced (eBICLA) required complete resolution all activity (all A/B D; worsening C D scores); 5 met both SRI(4) criteria. Results: Evaluated (MUSE, n=99; TULIP-2, n=180) n=102; n=184; n=182). rate differences favoring over observed endpoints across (Figure 1). proportion responses More (treatment difference, 15.3%–19.3%; nominal P ?0.006). eBICLA (requiring disease activity) 11.1%–14.1%; ?0.017). In addition, responders 14.3%–28.6%; ?0.004). Conclusion: SLE, consistently associated improved control including requiring activity, References: [1]Furie R, et al. Arthritis Rheumatol . 2017;69:376–86. [2]Furie RA, Lancet 2019;1:e208–19. [3]Morand EF, N Engl J Med. 2020;382:211–21. Acknowledgements: Writing assistance Rosie Butler, PhD, JK Associates Inc., part Fishawack Health. This study sponsored AstraZeneca. Disclosure Interests: David Isenberg Consultant of: AstraZeneca, Celgene, Merck Serono, UCB, Servier, Ian N. Bruce Speakers bureau: GSK, Eli Lilly, ILTOO, Grant/research support from: Genzyme/Sanofi, Roche, Richard Furie Eric F. Morand Yoshiya Tanaka AbbVie, Asahi Kasei, Astellas, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Gilead, Janssen, Mitsubishi-Tanabe, Novartis, Pfizer, Sanofi, YL Biologics, Takeda, Susan Manzi Kenneth Kalunian Konstantina Psachoulia Employee Emmanuelle Maho Raj Tummala AstraZeneca