AstraZeneca's anifrolumab meets endpoints in lupus study

Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) experimental anifrolumab met the primary and secondary goals of a Phase II study, significantly reducing lupus compared with placebo across multiple endpoints.

The 305 adult participants with seropositive moderate-to-severe systemic lupus erythematosus (SLE) in the trial were randomized to receive one of two doses of intravenous anifrolumab or placebo every four weeks for 48 weeks. The study met its main goal of difference in the percentage of patients achieving response as measured by the SLE Responder Index 4 (SRI4) at day 169, and a sustained reduction of oral corticosteroid use between day 85 and day 169.

The company said that responses occurred for 34.4% of patients receiving the lower dose of anifrolumab and for 28.8% given the higher dose, versus 17.6% for placebo. AstraZeneca stated that the trial met both the established secondary endpoints for efficacy: 51.5% of patients receiving the lower dose of anifrolumab and 38.5% on the higher dose achieved SRI4 response at day 365 with sustained reduction of OCS, compared with 25.5% of those given placebo. The other secondary endpoint of reducing oral corticosteroid use was met.