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ARTICLE | Clinical News

Anifrolumab: Phase II data

November 16, 2015 8:00 AM UTC

A double-blind, international Phase II trial in 305 patients with seropositive moderate to severe SLE showed that 300 mg IV anifrolumab every 4 weeks met the primary endpoint of a greater proportion of patients achieving an SRI-4 response at day 169 with a sustained reduction of oral corticosteroid use between day 85 and 169 vs. placebo (34.4% vs. 17.6%, p=0.014). The 1,000 mg dose of anifrolumab every 4 weeks missed the primary endpoint vs. placebo (28.8%, p=0.063). Low- and high-dose anifrolumab both met the secondary endpoint of a greater proportion of patients achieving an SRI-4 response at 1 year with a sustained reduction of oral corticosteroid use vs. placebo (51.5% and 38.5%, respectively, vs. 25.5%, p<0.001 and p=0.048). In patients taking >=10 mg/day of oral corticosteroids at baseline, 56.4% and 31.7% of patients receiving low- and high-dose anifrolumab had a reduction in corticosteroid use to <=7.5 mg/day by 1 year vs. 26.6% of patients receiving placebo (p=0.001 and p=0.595, respectively). ...