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.
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