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New Phase III study results support self-administered Saphnelo as an effective treatment option for systemic lupus erythematosus
AstraZeneca reported positive results from a Phase III TULIP-SC clinical trial, showing a statistically significant and clinically meaningful reduction in disease activity with the subcutaneous (SC), self-administration of Saphnelo (anifrolumab) in adults with systemic lupus erythematosus (SLE). The safety profile observed with SC Saphnelo was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion.
In the 52-week study, 56.2% of study participants receiving Saphnelo experienced a significant reduction in lupus disease activity at week 52 compared to 37.1% of participants who received the placebo. Results were measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). In pre-specified secondary and exploratory endpoints, 29.0% of participants taking Saphnelo achieved remission and 40.1% achieved low disease activity by week 52. SC Saphnelo was well tolerated, with the frequency of overall adverse events balanced between the Saphnelo and placebo groups, SC Saphnelo is approved in the European Union and is under regulatory review in other countries, including the United States and Japan.
Continue to follow the Lupus Foundation of America for updates on lupus drug developments. Learn more about Saphnelo.