Sifalimumab: Phase IIb data

AstraZeneca's MedImmune LLC unit reported top-line data from a double-blind, international Phase IIb trial in 431 patients with moderate to severe active SLE showing that 200, 600 and 1,200 mg doses of IV sifalimumab given every 2 weeks for 4 weeks and then once monthly for 44 weeks plus standard of care (SOC) each met the primary endpoint of a greater proportion of patients achieving an SRI-4 response at 1 year vs. placebo plus SOC. The company also said that sifalimumab plus SOC met the secondary endpoints of improving skin rashes as measured by CLASI scores and of improving fatigue vs. placebo plus SOC, but did not disclose which doses of sifalimumab. Detailed data will be submitted for presentation at the American College of Rheumatology meeting in Boston in November. ...