AstraZeneca Reports Positive Interim Data for Subcutaneous Saphnelo in SLE

AstraZeneca’s fully human monoclonal antibody, Saphnelo (anifrolumab), demonstrated reduced disease activity in systemic lupus erythematosus (SLE) patients via subcutaneous (SC) administration, according to a pre-specified interim analysis of the Phase III TULIP-SC trial. The double-blind, placebo-controlled, multi-centre study evaluated moderately to severely active autoantibody-positive SLE patients receiving either 120mg SC weekly doses or placebo alongside standard therapy.

Interim results, after 220 patients completed 52 weeks, showed that SC Saphnelo’s safety profile aligns with prior intravenous data. Disease activity reduction was assessed using the BICLA score, requiring improvement across all affected organs without new flares. Participants completing the initial phase are eligible for an open-label extension.

These findings, relevant as about half of SLE patients on biologics use self-administered SC options, are under regulatory review and will be presented at ACR Convergence 2025. Saphnelo IV is already approved in over 70 countries.

22-09-2025