Subcutaneous Anifrolumab in SLE Save

TULIP-SC was a phase 3, double-blind, placebo-controlled to evaluate the efficacy and safety of SC anifrolumab in moderate-to-severe SLE activity, despite standard therapy.

Active SLE patients were randomized to either subcutaneous anifrolumab 120 mg or placebo once weekly for 52 weeks (1:1 randomization). The primary endpoint was the treatment difference in BILAG-based Composite Lupus Assessment [BICLA] response at 52 weeks. 

At week 52, 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).

From a total of 367 patients (anifrolumab: n=184; placebo: n=183), 52 wk. responses to anifrolumab were compared to placebo treatment:

• BICLA response (whilst maintaining low/reduced oral glucocorticoid doses - 56.2% vs 34.0%; difference=22.3% [12.3−32.2] p<0.0001)
• Time to first sustained BICLA response was reduced (Hazard ratio=2.2 [1.5−3.2]; p<0.0001).
• 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).
• Serious adverse events:11.9% with anifrolumab and 10.4% with placebo;
  • Herpes zoster were 3.8% and 1.1%, respectively.

Consistent with the standard of intravenous anifrolumab, subcutaneous anifrolumab demonstrated significant efficacy and an acceptable safety profile in patients with moderate to severe SLE.