AstraZeneca reports Saphnelo demonstrates reduction in disease activity

Results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus showed that the subcutaneous administration of AstraZeneca’s (AZN) Saphnelo demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo. The safety profile observed in the interim analysis was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion. The TULIP-SC trial evaluated the efficacy and safety of the subcutaneous administration of Saphnelo compared to placebo in participants with moderately to severely active, autoantibody-positive SLE, with both treatment groups receiving standard therapy. The reduction in disease activity in TULIP-SC was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment at week 52.5 The BICLA requires improvement in all organs with disease activity at baseline with no new flares. The TULIP-SC interim results are under regulatory review and will be presented during the American College of Rheumatology Convergence 2025 annual meeting, 24-29 October.