Results from a Phase II, randomized, double-blind, placebo-controlled, dose-ranging trial designed to evaluate the efficacy and safety of brodalumab (formerly AMG 827) in 198 patients with moderate to severe plaque psoriasis have been published in the New England Journal of Medicine.
The researchers of the 12 week study randomly assigned participants with a psoriasis area and severity index (PASI) score of 12 or more and affected body surface area 10 percent or more to receive brodalumab (70 mg, 140 mg or 210 mg at day one and weeks 1,2,4,6,8 and 10 or 280 mg monthly), or placebo.
The primary endpoint of the study was achieved in all brodalumag groups, whose average improvement in psoriasis area (in percentage) and severity index (PASI) was higher than those of patients in the placebo group (p
In this Phase 2 study, brodalumab showed a high level of response in patients with moderate to severe plaque psoriasis with a rapid onset of action within days. Based on these results, additional clinical trials are warranted to further assess the safety and efficacy of brodalumab.”
Psoriasis is a chronic disease of the immune system that causes the skin cells to grow at a faster rate. Worldwide, the condition affects around 125 million individuals. Even though several types of psoriasis exist, around 80% of sufferers have plaque psoriasis. Plaque psoriasis can cause painful and itchy red, scaly patches to appear on the skin.
In this study, the researchers found that participants who received 140 mg of brodalumab every other week had a mean improvement in PASI score of 85.9%, 86.3% among participants who received 210 mg, and 45.0% for 70 mg, compared with 16.0% among participants who received placebo (all p