AstraZeneca announced that the Phase III TULIP-SC trial of SAPHNELO (anifrolumab) for treatment of people with systemic lupus erythematosus met its primary endpoint. Trial results showed that subcutaneous administration of the therapy demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo, measured by British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. The safety profile of the administration was consistent with the known clinical profile of SAPHNELO IV infusion, which is already approved for moderate to severe SLE in more than 70 countries worldwide, treating more than 38,000 individuals to date.
The multicenter, double-blind, placebo-controlled trial investigated the safety and efficacy of subcutaneous anifrolumab in patients with moderately to severely active autoantibody-positive SLE. Participants, aged 18 to 70, received standard treatment alongside a weekly 120 mg dose of the antibody or a placebo via a prefilled syringe. An interim analysis was conducted after 220 participants completed 52 weeks of treatment, showing that the safety profile of subcutaneous delivery was consistent with that of intravenous infusions. Additionally, the study included an open-label extension phase for those completing the initial 52-week period.
Susan Manzi, MD, MPH, Lupus Foundation of America Medical Director and former Board Chair, is a principal investigator of the trial and suggests that the results open the door for anifrolumab to benefit a broader range of people with SLE, moving beyond oral corticosteroids, which have been shown to cause irreversible organ damage.
The TULIP-SC results are currently undergoing regulatory review and will be presented at this year’s American College of Rheumatology (ACR) Convergence. Learn more about Saphnelo.
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