AstraZeneca announces results of Saphnelo were statistically significant

Positive full results from the Phase III TULIP-SC trial showed the subcutaneous administration of Saphnelo demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo in patients with systemic lupus erythematosus, SLE. The results were published in Arthritis & Rheumatology. In the TULIP-SC full analysis, 56.2% of patients who received Saphnelo achieved a reduction in disease activity at Week 52 versus 37.1% receiving placebo, as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment, BICLA, which was consistent with results from previous trials. The safety profile observed in the TULIP-SC trial was consistent with the known clinical profile of Saphnelo administered as an intravenous, IV, infusion. The full results confirmed the findings from the interim analysis, which was statistically significant. In the TULIP-SC trial, Saphnelo demonstrated clinically meaningful effects across a range of outcome measures: reduction in SLE disease activity while tapering to low dose of OCS, more patients achieving a BICLA response sooner, and numerically delayed time to first flare. In pre-specified secondary and exploratory endpoints, 29.0% of patients taking Saphnelo achieved DORIS remission and 40.1% attained low-level disease activity, as measured by the Low-Level Disease Activity Score