WILMINGTON, DE — AstraZeneca announced positive interim results from its Phase III TULIP-SC trial showing that subcutaneous administration of SAPHNELO (anifrolumab) significantly reduced disease activity in patients with systemic lupus erythematosus (SLE) compared to placebo. The safety profile was consistent with the drug’s approved intravenous (IV) formulation.
The study evaluated SAPHNELO’s efficacy and safety in adults with moderately to severely active, autoantibody-positive SLE, alongside standard therapy such as corticosteroids, antimalarials, and immunosuppressants. Results were measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.
“Today’s results for subcutaneous anifrolumab reinforce the efficacy and safety of this therapy and provide the opportunity for this important biologic to reach a wider group of patients in a more flexible and convenient way,” said Susan Manzi, MD, MPH, Professor of Medicine at Allegheny Health Network and principal investigator of the trial.
AstraZeneca said the findings address a critical gap in treatment, as many SLE patients still rely heavily on corticosteroids, which can provide short-term relief but are linked to long-term complications and organ damage.
“Approximately half of systemic lupus erythematosus patients today taking a biologic are already treated with a self-administered subcutaneous option,” said Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca. “With SAPHNELO, we hope to establish remission as an achievable treatment goal for more patients.”
SLE affects more than 3.4 million people worldwide and can cause severe, multi-organ complications. SAPHNELO’s IV infusion is currently approved in more than 70 countries, including the U.S., EU, and Japan. More than 38,000 patients globally have received the treatment to date.
The new data will be presented at the American College of Rheumatology’s Convergence 2025 meeting in October. Regulatory submissions for the subcutaneous formulation are planned in the U.S. and Europe over the next year.
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