AstraZeneca’s Saphnelo (anifrolumab) Meets Primary Endpoint In Phase III TULIP-SC Trial For Systemic Lupus Erythematosus (SLE)

AstraZeneca today announced positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial evaluating the subcutaneous (SC) administration of Saphnelo (anifrolumab) in patients with systemic lupus erythematosus (SLE). Results showed that SC Saphnelo achieved a statistically significant and clinically meaningful reduction in disease activity compared to placebo, with a safety profile consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.

The TULIP-SC trial evaluated the efficacy and safety of SC Saphnelo versus placebo in patients with moderately to severely active, autoantibody-positive SLE, with both arms receiving standard therapy, including oral corticosteroids, antimalarials, and/or immunosuppressants. Disease activity reduction was measured using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52, which requires improvement in all baseline-affected organs with no new flares.

Susan Manzi, MD, MPH, Professor of Medicine and Chair of the Medicine Institute at Allegheny Health Network, Professor of Medicine at Drexel University College, Philadelphia and principal investigator of the TULIP-SC trial, said, “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. Despite guidelines recommending earlier intervention and biologic treatments, too many people with systemic lupus erythematosus rely on oral corticosteroids, which contribute to irreversible organ damage.”

SLE affects over 3.4 million people worldwide and can cause debilitating symptoms, irreversible organ damage, and poor quality of life. While corticosteroids are commonly used, they are linked to adverse events and fail to address underlying disease drivers, making long-term disease control and remission difficult to achieve. Recent guideline updates emphasise the importance of treating to target remission or low disease activity while minimising steroid use.

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said, “Today’s news takes us one step closer in making the clinically meaningful benefits of Saphnelo accessible for more patients with systemic lupus erythematosus. The TULIP-SC results are especially important because approximately half of systemic lupus erythematosus patients today taking a biologic are already treated with a self-administered subcutaneous option. With Saphnelo, we hope to establish remission as an achievable treatment goal for more patients and we are actively working with regulatory authorities to bring this new administration option to patients as soon as possible.”

The TULIP-SC interim results are under regulatory review and will be presented at the American College of Rheumatology (ACR) Convergence 2025, taking place from 24–29 October 2025. Saphnelo IV is currently approved in more than 70 countries, including the US, EU, and Japan, with over 38,000 patients treated worldwide to date.