AstraZeneca's Injectable Saphnelo Shows Promise in Treating Systemic Lupus Erythematosus

AstraZeneca announced a Phase 3 trial win for injectable Saphnelo, an FDA-approved therapy for systemic lupus erythematosus. The trial, called TULIP-SC, reached its primary endpoint with interim data. Saphnelo is an autoimmune disorder treatment developed by AstraZeneca.

AstraZeneca has reported positive interim results from the Phase 3 TULIP-SC trial, which evaluated the efficacy and safety of subcutaneous administration of their biologic therapy, SAPHNELO® (anifrolumab), in patients with systemic lupus erythematosus (SLE). The trial, which reached its primary endpoint, demonstrated statistically significant and clinically meaningful reduction in disease activity compared to placebo.

The TULIP-SC trial enrolled 367 participants with moderately to severely active, autoantibody-positive SLE who were receiving standard therapy. Patients were randomized 1:1 to receive either 120mg of subcutaneous anifrolumab or placebo once weekly via an accessorized prefilled syringe. The interim analysis, conducted when the first 220 participants reached week 52, showed that the subcutaneous administration of SAPHNELO® resulted in a significant reduction in disease activity, as measured by the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.

The safety profile observed in the interim analysis was consistent with the known clinical profile of SAPHNELO® administered as an intravenous (IV) infusion. The most common adverse reactions (incidence ≥ 5%) were nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster, and cough. The incidence of infusion-related reactions was 9.4% in patients receiving SAPHNELO® and 7.1% in the placebo group.

The trial results are under regulatory review and will be presented during the American College of Rheumatology (ACR) Convergence 2025 annual meeting, scheduled from October 24 to October 29, 2025. SAPHNELO® is currently approved for the treatment of moderate to severe SLE in over 70 countries, including the US, EU, and Japan, with ongoing regulatory reviews in other countries.

AstraZeneca acquired global rights to SAPHNELO® through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The company has been actively working with regulatory authorities to bring this new administration option to patients as soon as possible.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects over 3.4 million people globally. It is characterized by the immune system attacking healthy tissue, leading to a variety of symptoms and potential organ damage. While oral corticosteroids are commonly used to manage SLE symptoms, they often fail to target the underlying drivers of the disease and can contribute to irreversible organ damage. The TULIP-SC trial results suggest that subcutaneous administration of SAPHNELO® may offer a more effective and convenient treatment option for patients with SLE.