AstraZeneca's phase III TULIP 2 trial of anifrolumab to treat systemic lupus erythematosus meets primary endpoint

AstraZeneca announced that the phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care. The reduction was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. The BICLA requires improvement in all organs with disease activity at baseline with no new flares. The safety profile of anifrolumab was consistent with previous trials. TULIP 2 was the second phase III trial designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. The positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous phase III TULIP 1 trial, which did not meet its primary endpoint of SLE Responder Index 4 (SRI4). Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “Systemic lupus erythematosus is a debilitating autoimmune disease, but only one new treatment has been approved in the last 60 years. These are important results and we will now review the full data set and explore pathways to bring this potential new treatment to patients.” Professor Eric F. Morand, Monash University, Australia, and Principal Investigator on the TULIP 2 trial said: “As clinicians we need new medicines for this complex and difficult-to-treat disease. These exciting results from the TULIP 2 trial demonstrate that, by targeting the type I interferon receptor, anifrolumab reduced disease activity in patients with systemic lupus erythematosus.”

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