By: IPP Bureau
Last updated : September 18, 2025 8:30 am
The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo
AstraZeneca announced positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial, which evaluated the subcutaneous administration of Saphnelo (anifrolumab) in patients with systemic lupus erythematosus (SLE). The analysis demonstrated that self-administered Saphnelo significantly and clinically meaningfully reduced disease activity compared to placebo, meeting the trial’s primary endpoint. The safety profile observed was consistent with that of the intravenous (IV) formulation of Saphnelo.
The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo in patients with moderately to severely active, autoantibody-positive SLE who were receiving standard therapy, including oral corticosteroids, antimalarials, and immunosuppressants. Disease activity reduction was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52, which requires improvement across all affected organs at baseline without new flares.
SLE affects more than 3.4 million people globally and can involve multiple organs, often leading to debilitating symptoms, irreversible organ damage, and poor quality of life. While oral corticosteroids remain a common treatment, they are associated with significant side effects, short-term relief, and limited impact on underlying disease processes. Recent updates to clinical guidelines emphasise the importance of achieving remission or low disease activity while minimising corticosteroid use.
Professor Susan Manzi, MD, MPH, Chair of the Medicine Institute at Allegheny Health Network, Professor of Medicine at Drexel University College of Medicine, and principal investigator of the TULIP-SC trial, said: “These results confirm the efficacy and safety of subcutaneous anifrolumab and represent an important step toward making this therapy more accessible in a convenient self-administered form. Too many patients still depend on corticosteroids, which contribute to long-term organ damage, despite guidelines recommending earlier use of biologic therapies.”
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “The TULIP-SC results take us closer to expanding the reach of Saphnelo for patients with systemic lupus erythematosus. Around half of patients treated with biologics today use a self-administered subcutaneous option. With Saphnelo, our ambition is to make remission an achievable goal for more patients, and we are actively engaging with regulators to bring this new administration route to patients as quickly as possible.”
The interim results of TULIP-SC are currently under regulatory review and will be presented at the American College of Rheumatology (ACR) Convergence 2025 annual meeting, taking place from 24–29 October.
Saphnelo is already approved as an IV infusion for the treatment of moderate to severe SLE in more than 70 countries, including the US, EU, and Japan, with additional regulatory reviews ongoing. To date, more than 38,000 patients worldwide have been treated with Saphnelo.