India Pharma Outlook Team | Thursday, 18 September 2025
AstraZeneca announced today positive top-line results from the Phase III TULIP-SC study, assessing the subcutaneous administration of Saphnelo (anifrolumab) in patients with systemic lupus erythematosus (SLE).
The interim analysis met the primary endpoint of the trial by demonstrating that self-administered Saphnelo reduced disease activity compared with placebo.
The TULIP-SC trial evaluated subcutaneous Saphnelo in patients with autoantibody-positive, moderately to severely active SLE who had received stable doses of standard therapy that included corticosteroids, antimalarials, and immunosuppressants.
Disease activity was assessed by the British Isles Lupus Assessment Group–based Composite Lupus Assessment (BICLA) at week 52, and required improvement in all affected organ systems with no new flares. The safety profile of the subcutaneous formulation was similar to the established intravenous (IV) formulation.
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SLE has an estimated global prevalence of more than 3.4 million individuals, often resulting in severely debilitating symptoms, organ impairment, and diminished quality of life. Presently, reliance on corticosteroids provides only short-term relief and comes with long-term risks; therefore, the goal of developing more effective and safer biologic therapies is critically needed.
Professor Susan Manzi, the principal investigator of the TULIP-SC trial, spoke about the significance of the potential release, stating that the self-administered option could promote overall reductions in corticosteroid use.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said that expanding Saphnelo to a subcutaneous formulation brings them closer to their aim of bringing remission to more patients with SLE.
