FDA approves SC anifrolumab in addition to standard therapy for SLE

On April 27, 2026, the U.S. Food and Drug Administration (FDA) approved self-administered subcutaneous (SC) anifrolumab in addition to standard therapy for the treatment of adult patients with systemic lupus erythematosus (SLE).¹

This approval was based on results from the phase III TULIP-SC trial (NCT04877691), which evaluated SC anifrolumab in adults with moderate-to-severe SLE (N = 367).^1,2 In the full analysis, 56.2% of patients receiving SC anifrolumab achieved a British Isles Lupus Assessment Group (BILAG)-based composite lupus assessment (BICLA) response compared with 37.1% of patients receiving placebo (p = 0.0002).² Among patients who achieved a BICLA response, 56.2% and 34.0% of patients in the anifrolumab and placebo groups, respectively, maintained reduced oral glucocorticoid doses from Week 40 through Week 52 (p < 0.0001).² Definition of remission in SLE (DORIS; 29.0% vs 14.7%; p = 0.0012) and low lupus disease activity state (LLDAS; 40.1% vs 26.0%; p = 0.0038) attainment were greater in the anifrolumab vs placebo group at Week 52.² Adverse events were mild or moderate in intensity. Serious adverse events were observed in 11.9% of patients receiving anifrolumab vs 10.4% of those receiving placebo.²