AstraZeneca's Anifrolumab Meets Primary Endpoint in Lupus Trial
AstraZeneca announced that its Phase III TULIP 2 trial for anifrolumab, a potential new treatment for systemic lupus erythematosus (SLE), met its primary endpoint. The drug demonstrated a statistically significant and clinically meaningful reduction in disease activity.
AstraZeneca has reported positive top-line results from its Phase III TULIP 2 trial investigating the efficacy of anifrolumab for systemic lupus erythematosus (SLE). The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in disease activity compared to placebo, with both treatment arms receiving standard of care.
The reduction in disease activity was measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 52. This endpoint requires improvement across all organs with baseline disease activity and no new flares. The safety profile of anifrolumab in the trial was consistent with findings from earlier studies.
Systemic lupus erythematosus is a chronic autoimmune disease impacting multiple organs and causing symptoms such as fatigue, joint pain, and rashes. The approval of new treatments for SLE has been limited, with only one new medicine approved in the last 60 years, highlighting the unmet need for therapies. Full data from the TULIP 2 trial will be submitted for presentation at an upcoming medical meeting.
AstraZeneca stated it will now review the full data set and explore pathways to bring this potential new treatment to patients. These positive BICLA findings in TULIP 2 are consistent with a pre-specified analysis of data from the earlier Phase III TULIP 1 trial, which did not meet its primary endpoint of SLE Responder Index 4 (SRI4).