A novel interleukin-17 receptor antibody brodalumab appears effective against moderate-to-severe plaque psoriasis in both treatment-naive and experienced patients, manufacturers Amgen and AstraZeneca announced in a press release.
Results from the phase-3 AMAGINE-1 trial reveal that 83.3% of patients in the group treated with brodalumab 210 mg and 60.3% of patients treated with brodalumab 140 mg achieved the primary endpoint of Psoriasis Area and Severity Index (PASI) 75 at week 12 compared with the placebo group (2.7%).
A total of 70.3% of patients in the 210-mg group and 42.5% of patients in the 140-mg group achieved PASI 90 responses compared with placebo (0.9%). In addition, 41.9% of patients in the 210-mg group and 23.3% of patients in the 140- mg group achieved PASI 100 responses compared with placebo (0.5%).
Of the 661 patients enrolled in this study, 46% reported prior biologic use and 28.7% weighed more than 220 lbs. at baseline (mean weight for the study population was 200 lbs.)..
The most common adverse events reported during the placebo-controlled period in the brodalumab group included nasopharyngitis, upper respiratory tract infection and headache (more than 5% of patients).
Serious adverse events occurred in 1.8% of patients in the 210-mg group and 2.7% of patients in the 140-mg group compared with 1.4% for placebo during the placebo-controlled period,.
AMAGINE-1 is one of three phase 3 studies designed to assess the efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis.
Two head-to-head phase 3 studies, AMAGINE-2 and AMAGINE-3, are currently underway to evaluate the efficacy and safety of brodalumab induction and maintenance regimens at different dose schedules in patients with moderate-to-severe plaque psoriasis compared with ustekinumab and placebo.