Researchers Report Positive Results for Brodalumab for Patients with Plaque Psoriasis

Amgen and AstraZeneca recently announced AMAGINE-2TM, a pivotal, multi-arm Phase 3 clinical trial, met all primary endpoints for brodalumab, an experimental drug designed for moderate to severe plaque psoriasis treatment.

The randomized, double-blinded study evaluated 2 doses of brodalumab in more than 1,800 individuals. Researchers reported that 44.4% of patients on 210 mg of brodalumab, 33.6% of patients in brodalumab weight-based group, and 25.7% of patients on 140 mg of brodalumab had attained full clearance of the skin disease.

Patients treated with brodalumab also had better outcomes compared to patients who were treated with Johnson & Johnson’s Stelara, currently one of the plaque psoriasis treatment options, and placebo at 12 weeks.

Common side effects of brodalumab include cold, upper respiratory tract infection, headache, and joint pain. Additionally, it is being tested for psoriatic arthritis and is in Phase-II trials for evaluating its efficacy in treating asthma.

Sean E. Harper, MD, executive vice president of Research and Development at Amgen said, “Results from AMAGINE-2 underscore that treatment with brodalumab could help a significant number of moderate to severe plaque psoriasis patients achieve total clearance of their skin disease, and the great majority achieve at least a 75 percent improvement in their disease. AMAGINE-2 is the third and final pivotal study in our Phase 3 psoriasis program and the robust data from these studies will form basis of our global filing plan. We look forward to discussions with regulatory authorities.”

Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor, inhibiting inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor, which are key in plaque psoriasis development and clinical manifestations.

Briggs W. Morrison, MD, executive vice president of Global Medicines development at AstraZeneca said, “These results confirm our belief that targeting the IL-17 receptor to inhibit inflammatory signaling can have significant benefit for psoriasis patients. We look forward to sharing detailed results from the AMAGINE program in upcoming scientific forums.”