SAT0174 FLARE ASSESSMENTS IN PATIENTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS TREATED WITH ANIFROLUMAB IN 2 PHASE 3 TRIALS
Authors: R. Furie, E. F. Morand, A. Askanase, E. Vital, R. Kalyani, G. Abreu, L. Pineda, R. Tummala
Journal: Annals of the Rheumatic Diseases (2020)

Background: Anifrolumab treatment resulted in improved British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA) response rates in patients with systemic lupus erythematosus (SLE) in the phase 3 TULIP-2 and TULIP-1 trials. 1,2 In addition, annualized flare rates were lower among the groups treated with anifrolumab compared with placebo. 1,2 Objectives: TULIP-2 and TULIP-1 data were analyzed to assess the effects of anifrolumab on the number of SLE flares and time to first flare during 52 weeks of treatment. Methods: The randomized, double-blind, placebo-controlled TULIP-2 and TULIP-1 trials evaluated efficacy and safety of intravenous anifrolumab 300 mg vs placebo every 4 weeks for 48 weeks, with the primary endpoints assessed at Week 52, in patients with moderate to severe SLE despite standard-of-care treatment. Flares were defined as ≥1 new BILAG-2004 A or ≥2 new (worsening) BILAG-2004 B domain scores compared with the prior month’s visit. Time to first flare was evaluated using a Cox proportional hazards model. Annualized flare rate was analyzed using a negative binomial regression model. Results: In TULIP-2 (anifrolumab, n=180; placebo, n=182) and TULIP-1 (anifrolumab, n=180; placebo, n=184), fewer patients experienced ≥1 BILAG-2004 flare in the anifrolumab groups (TULIP-2: 31.1%, n=56; TULIP-1: 36.1%, n=65) compared with the placebo groups (TULIP-2: 42.3%, n=77; TULIP-1: 43.5%, n=80; Figure 1). Results favoring anifrolumab were observed in time to first flare (TULIP-2: hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.46–0.91 and TULIP-1: HR 0.76, 95% CI 0.55–1.06; Figure 2) and BILAG-based annualized flare rates (TULIP-2: adjusted rate ratio 0.67, 95% CI 0.48–0.94 and TULIP-1: rate ratio 0.83, 95% CI 0.60–1.14) across both trials. Conclusion: Across 2 phase 3 trials, we observed reductions in the total number of flares and annualized flare rates, as well as prolongation of time to first flare with anifrolumab treatment compared with placebo. These results support the potential of anifrolumab to reduce disease activity and reduce flares, benefiting patients with SLE. References: [1]Morand EF, et al. N Engl J Med . 2020;382:211–221. [2]Furie RA, et al. Lancet Rheumatol. 2019;1:e208–e219. Disclosure of Interests: Richard Furie Grant/research support from: AstraZeneca, Biogen, Consultant of: AstraZeneca, Biogen, Eric F. Morand Grant/research support from: AstraZeneca, Consultant of: AstraZeneca, Speakers bureau: AstraZeneca, Anca Askanase Grant/research support from: Regeneron and Pfizer, Consultant of: AbbVie and BMS, Employee of: GSK, AstraZeneca, Janssen, Lilly, and Mallinckrodt, Edward Vital Grant/research support from: AstraZeneca, Roche/Genentech, and Sandoz, Consultant of: AstraZeneca, GSK, Roche/Genentech, and Sandoz, Speakers bureau: Becton Dickinson and GSK, Rubana Kalyani Employee of: AstraZeneca, Gabriel Abreu Employee of: AstraZeneca, Lilia Pineda Employee of: AstraZeneca, Raj Tummala Employee of: AstraZeneca