AstraZeneca Saphnelo Trial Shows Significant Reduction in Lupus Disease Activity
New Phase III trial results indicate AstraZeneca's Saphnelo, when administered subcutaneously, significantly reduced disease activity in patients with systemic lupus erythematosus (SLE).
AstraZeneca has reported positive full results from the Phase III TULIP-SC trial evaluating the subcutaneous (SC) administration of Saphnelo (anifrolumab) for systemic lupus erythematosus (SLE). The study demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo.
At Week 52, 56.2% of patients receiving Saphnelo achieved a reduction in disease activity, as measured by BICLA (British Isles Lupus Assessment Group-based Composite Lupus Assessment), versus 37.1% in the placebo group. The safety profile observed was consistent with the known safety profile of Saphnelo administered intravenously.
SLE is a chronic autoimmune disease that can cause significant organ damage and increase the risk of premature death. Current treatment guidelines emphasize achieving remission and reducing the use of oral corticosteroids (OCS) to minimize long-term complications.
The trial also showed that Saphnelo enabled patients to reduce their reliance on oral corticosteroids. These findings reinforce previous research and offer a new subcutaneous delivery option, which may enhance patient convenience and support the achievement of remission and reduced disease activity.