AstraZeneca has reported positive interim results from the Phase 3 TULIP-SC trial, showing that subcutaneous administration of Saphnelo (anifrolumab) led to a statistically significant and clinically meaningful reduction in disease activity in patients with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE). The safety profile observed was consistent with Saphnelo administered as an intravenous infusion.

The trial compared subcutaneous Saphnelo with placebo, with both groups receiving standard therapy including oral corticosteroids, antimalarials, and/or immunosuppressants. SLE affects over 3.4 million people globally and can impact multiple organs, leading to debilitating symptoms, irreversible organ damage, and reduced quality of life. Oral corticosteroids, while commonly used, carry risks and do not address the underlying disease, highlighting the need for therapies that achieve remission or low disease activity.

Susan Manzi, professor of medicine and principal investigator of TULIP-SC, 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.”

The reduction in disease activity was assessed using the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) at week 52, which requires improvement in all organs with disease activity at baseline and no new flares.

Sharon Barr, executive vice president of bioPharmaceuticals R&D at AstraZeneca, added: “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.”

Interim results from TULIP-SC are under regulatory review and will be presented at the American College of Rheumatology Convergence 2025 annual meeting, scheduled for 24-29 October 2025. Saphnelo intravenous infusion is approved in more than 70 countries, including the US, EU, and Japan, with regulatory reviews ongoing elsewhere. Over 38,000 patients worldwide have received treatment with Saphnelo to date.