TULIP-SC: Subcutaneous anifrolumab shows efficacy in SLE

Results from the multinational, phase III, double-blind, placebo-controlled TULIP-SC (NCT04877691) trial of subcutaneous (SC) anifrolumab in adults with moderate-to-severe systemic lupus erythematosus (SLE) (N = 367) were recently published in Arthritis & Rheumatology by Manzi et al. The primary endpoint was the proportion of patients attaining BILAG-based composite lupus assessment (BICLA) response at Week 52 and the key secondary endpoint was the proportion of BICLA responders that met the pre-specified threshold for reduced glucocorticoid dosing from Week 40 to Week 52.

Key data: At the interim analysis (n = 220), the primary endpoint was met with more patients achieving BICLA response at Week 52 in the anifrolumab 120 mg group compared with placebo (59.4% vs 43.9%, respectively; p = 0.0211). Consistent results were observed in the full analysis (56.2% vs 37.1% for anifrolumab and placebo, respectively; p = 0.0002). Significantly more BICLA responders receiving anifrolumab maintained reduced oral glucocorticoid doses from Week 40 to Week 52 compared with placebo (56.2% vs 34.0%; p < 0.0001). Anifrolumab demonstrated greater definition of remission in SLE (DORIS) remission attainment (29.0% vs 14.7%; p = 0.0012) and low lupus disease activity state (LLDAS) attainment (40.1% vs 26.0%; p = 0.0038) at Week 52 compared with placebo. The safety profile was well tolerated, with serious adverse events (AEs) occurring in 11.9% of patients treated with anifrolumab and 10.4% treated with placebo.

Key learning: SC anifrolumab demonstrated clinically meaningful treatment benefits in patients with moderate-to-severe SLE, with efficacy and safety results that are consistent with the approved intravenous (IV) formulation, providing an alternative at-home administration option for improved treatment accessibility.