AZ reports Phase II SLE data

The MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) said the lower of two doses of anifrolumab ( MEDI-546) showed a statistically significant improvement on the primary endpoint in a Phase II trial to treat moderate to severe systemic lupus erythematosus. Data for the human mAb targeting type I interferon (IFN) receptor 1 were presented at the American College of Rheumatology meeting in San Francisco.

Patients received either 300 mg or 1,000 mg doses of IV anifrolumab or placebo every four weeks for 48 weeks. The primary endpoint was the proportion of patients achieving an SLE Responder Index-4 (SRI-4) response at day 169 as well as a sustained reduction of oral corticosteroid use between day 85 and 169. AZ said 34.4% of patients in the 300 mg group met the endpoint compared with 17.6% of patients in the placebo group (p=0.014). In the high-dose group, 28.8% of patients met the endpoint vs. placebo (p=0.063). ...