The TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE) did not meet the primary endpoint.- AstraZeneca

AstraZeneca and MedImmune, announced top-line results from the from the 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 SLE as measured by the SLE Responder Index 4 (SRI4) at 12 months.

The pivotal Phase III TULIP 1 trial was a randomised, double-blinded, 52-week placebo-controlled, multi-centre trial assessing the safety and efficacy of anifrolumab 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.

A second trial, TULIP 2, compares a fixed dose of 300 mg of anifrolumab every four weeks against placebo for 373 patients. Topline results are expected later this year, according to the company.