LONDON (dpa-AFX) - AstraZeneca (AZN) announced positive results from the Phase III TULIP-SC trial, which evaluated subcutaneous - SC administration of Saphnelo - anifrolumab in patients with systemic lupus erythematosus - SLE.
The trial showed a statistically significant and clinically meaningful reduction in disease activity versus placebo, with safety consistent with Saphnelo's established intravenous (IV) profile.
The study involved patients with moderately to severely active, autoantibody-positive SLE who received standard therapy alongside either SC Saphnelo or placebo. Efficacy was measured using the BICLA score at week 52, requiring improvement in all baseline-affected organs without new flares.
Principal investigator Dr. Susan Manzi said the findings confirm Saphnelo's efficacy and safety, offering a more flexible and convenient treatment option that could reduce reliance on oral corticosteroids, which contribute to long-term organ damage.
AstraZeneca's Sharon Barr emphasized that making Saphnelo available as a self-administered SC option could help more patients reach remission, aligning with updated treatment guidelines that prioritize disease control and minimized steroid use.
The interim results are under regulatory review and will be presented at ACR Convergence 2025. Saphnelo IV is already approved in over 70 countries, with more than 38,000 patients treated globally.
AZN currently trades at $77.71 or 0.19 percent higher on the NasdaqGS.
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