AstraZeneca's SAPHNELO subcutaneous trial hits primary endpoint

AstraZeneca reported that its Phase III TULIP-SC trial evaluating subcutaneous administration of SAPHNELO (anifrolumab) met its primary endpoint in patients with systemic lupus erythematosus. The interim analysis showed a statistically significant reduction in disease activity compared to placebo at week 52.

The trial enrolled 367 participants with moderately to severely active, autoantibody-positive SLE who received either 120mg subcutaneous anifrolumab or placebo once weekly, alongside standard therapy including oral corticosteroids, antimalarials, and immunosuppressants. The primary endpoint was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment.

SAPHNELO is currently approved as an intravenous infusion for moderate to severe SLE treatment in more than 70 countries, with over 38,000 patients treated globally. The drug is a monoclonal antibody that blocks type I interferon receptor activity.

The safety profile observed in the subcutaneous formulation was consistent with the known profile of the IV version. AstraZeneca stated it is working with regulatory authorities to bring the subcutaneous option to patients.

Results from the interim analysis will be presented at the American College of Rheumatology Convergence 2025 meeting in October. The trial includes a 52-week open-label extension period for participants who completed the initial treatment period.

AstraZeneca pays Bristol-Myers Squibb a low to mid-teens royalty for SAPHNELO sales under a licensing agreement from 2004.

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