Brodalumab: Phase II data

A double-blind, international Phase II trial in 198 patients with moderate to severe plaque psoriasis showed that all doses of brodalumab met the primary endpoint of a greater percentage improvement in PASI score from baseline to week 12 vs. placebo. Specifically, 70, 140, 210 and 280 mg doses of subcutaneous brodalumab led to improvements in PASI score from baseline of 45%, 85.9%, 86.3% and 76%, respectively, vs. 16% for placebo (p<0.001 for all). On secondary endpoints, a significantly greater proportion of patients receiving each respective dose of brodalumab achieved a PASI 75 (33%, 77%, 82% and 67%, respectively, vs. 0%, p<0.001 for all) and PASI 90 response at week 12 vs. placebo (18%, 72%, 75% and 57%, respectively, vs. 0%, p<0.01 for all).

Additionally, a significantly greater proportion of patients receiving each respective dose of brodalumab achieved a static PGA score of "clear" or "minimal" at week 12 vs. placebo (26%, 85%, 80% and 69%, respectively, vs. 3%, p<0.01 for all). There were 2 cases of grade 3 neutropenia reported in patients receiving the 210 mg brodalumab dose. The most common adverse events were nasopharyngitis, upper respiratory tract infection and injection-site erythema. Patients received placebo or subcutaneous brodalumab at a dose of 70, 140 or 210 mg on day 1 and at weeks 1, 2, 4, 6, 8 and 10, or at a dose of 280 mg on day 1 and at weeks 4 and 8. Data were published in the New England Journal of Medicine. Amgen said it plans to start Phase III testing of brodalumab to treat psoriasis, but did not disclose a time frame. ...