Eficacia y seguridad de anifrolumab subcutáneo en el lupus eritematoso sistémico: estudio aleatorizado, de fase 3,...

The multinational, phase 3, double-blind, placebo-controlled TULIP-SC trial evaluated the efficacy and safety of subcutaneous anifrolumab in adults who have moderate-to-severe SLE activity, despite receiving standard therapy.

Adults with SLE received subcutaneous anifrolumab 120 mg or placebo once weekly for 52 weeks (1:1 randomization). Only the primary endpoint (treatment difference in BILAG-based Composite Lupus Assessment [BICLA] response at 52 weeks) was formally tested in a pre-planned interim analysis; key secondary and other endpoints were tested in the full analysis.

At the interim analysis (220 patients, anifrolumab: n=109; placebo: n=111), the primary endpoint was met (anifrolumab vs placebo: 59.4% vs 43.9%; BICLA response difference [95% confidence interval]=15.5% [2.3-28.6%], p=0.0211). The full analysis included 367 patients (anifrolumab: n=184; placebo: n=183). Versus placebo, more patients treated with anifrolumab attained a BICLA response whilst maintaining low/reduced oral glucocorticoid doses through Week 52 (56.2% vs 34.0%; difference=22.3% [12.3-32.2] p<0.0001), and the time to first sustained BICLA response was reduced (Hazard ratio=2.2 [1.5-3.2]; p<0.0001). Treatment differences in Week 52 DORIS remission and Low Lupus Disease Activity State attainment rates favored anifrolumab over placebo (14.2% [5.6-22.8%], p=0.0012, and 14.1% [4.6-23.6%], p=0.0038). The frequencies of serious adverse events were 11.9% with anifrolumab and 10.4% with placebo; the frequencies of herpes zoster were 3.8% and 1.1%, respectively.

Consistent with the well-established profile of intravenous anifrolumab, subcutaneous anifrolumab demonstrated significant, clinically meaningful treatment benefits when added to standard therapy, and an acceptable safety profile in patients with moderate to severe SLE.