O25 Efficacy of anifrolumab in active systemic lupus erythematosus (SLE): patient subgroup analysis of BICLA response in 2 phase 3 trials. (23rd March 2020)

• Record Type: Journal Article
• Authors: Morand, Eric F; Furie, Richard; Tanaka, Yoshiya; Kalyani, Rubana N; Abreu, Gabriel; Pineda, Lilia; Tummala, Raj
• Is Part Of: Lupus science & medicine. Volume 7(2020)Supplement 1
• Page Start: A20
• Page End: A21
• Publication Date: 2020-03-23
• Subjects: Systemic lupus erythematosus -- Periodicals; 616.772005
• DOI: 10.1136/lupus-2020-eurolupus.36
• Languages: English
• ISSNs: 2398-8851

Abstract

Abstract : Background: Treatment of patients with SLE with anifrolumab resulted in higher BICLA response rates vs placebo at Week 52 in the phase 3 trials, TULIP-2 (16.3% difference; Morand et al, 2020) and TULIP-1 (16.4% difference; Furie et al, 2019). We evaluated BICLA responses to anifrolumab vs placebo at Week 52 in protocol-defined subgroups of patients with active SLE enrolled in the TULIP trials. Methods: TULIP-2 and TULIP-1 were randomized, double-blind, placebo-controlled trials that evaluated efficacy and safety of intravenous anifrolumab vs placebo administered every 4 weeks, with the primary endpoints assessed at Week 52, in patients with moderate to severe SLE despite standard-of-care treatment. 1, 2 BICLA responses were compared between anifrolumab 300 mg and placebo groups, and robustness of BICLA responses was assessed across protocol-defined subgroups. Results: TULIP-2 (anifrolumab, n=180; placebo, n=182) and TULIP-1 (anifrolumab, n=180; placebo, n=184) had comparable BICLA responses (figure 1 ). Across multiple subgroups, higher percentages of patients achieved BICLA responses at Week 52 in the anifrolumab vs placebo arms. There was concordance of BICLA responses favoring anifrolumab across the protocol-defined subgroups of baseline disease severity (SLEDAI-2K <10 points [difference 15.3%, TULIP-2; 16.9%, TULIP-1] vs ≥10 points [difference 16.7%, TULIP-2; 17.1%, TULIP-1]) and baseline oral corticosteroid use (prednisone or equivalent <10 mg/d [difference 20.1%, TULIP-2; 16.2%, TULIP-1] vs ≥10 mg/d [difference 12.0%, TULIP-2; 17.7%, TULIP-1]). Other subgroups including age, sex, age at onset, race, and anti-drug antibody status showed similar uniformity of response. Conclusions: The uniformity of robust BICLA response rates across prespecified subgroups in both phase 3 trials shows consistent clinical benefit of anifrolumab irrespective of patient baseline characteristics.