AstraZeneca and MedImmune have announced new results from their TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE).
The trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLEas measured by the SLE Responder Index 4 (SRI4)at 12 months.
“SLE is a debilitating autoimmune disease with significant unmet need among patients who struggle to achieve meaningful disease control. The result of this trial is disappointing for patients and the lupus community,” says Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer.
The pivotal Phase III TULIP 1 trial was a randomised, double-blinded, 52-week placebo-controlled, multi-centre trial assessing the safety and efficacy ofanifrolumab as a treatment for adult patients with moderate-to-severe SLE. A full evaluation of the data will be conducted when TULIP 2 data are available later this year. TULIP 1 data will be presented at a future medical meeting.