Brodalumab demonstrates positive results in plaque psoriasis study

May 13, 2014

A phase 3 trial of brodalumab (AMG 827) for the treatment of patients with moderate-to-severe plaque psoriasis demonstrated positive results, meeting primary and secondary endpoints.

A phase 3 trial of brodalumab (AMG 827) for the treatment of patients with moderate-to-severe plaque psoriasis demonstrated positive results, meeting primary and secondary endpoints.

The drug, developed by Amgen and AstraZeneca, is a monoclonal antibody that binds to the interleukin-17 (IL-17) receptor, helping to inhibit inflammatory signaling, according to a news release.

The phase 3 AMAGINE-1TM study involved 661 patients who were given subcutaneous injections of brodalumab every two weeks at doses of 140 mg or 210 mg or were given placebo. The study’s primary endpoints were patients achieving a 75 percent improvement in disease severity on the Psoriasis Area Severity Index (PASI 75) and patients demonstrating clear or almost clear skin at week 12 using the static Physician Global Assessment.

Among patients given brodalumab 210 mg, 83.3 percent achieved PASI 75 response, while 60.3 percent of patients given a dose of 140 mg also achieved PASI 75 response. PASI 90 was achieved in 70.3 percent of patients on the higher dose, and was achieved by 42.5 percent on the lower dose. One hundred percent improvement was shown in 41.9 percent of patients in the higher dose and 23.3 percent in the lower dose.

“Data from the AMAGINE-1 study suggest that brodalumab may offer a new level of efficacy for patients with moderate-to-severe plaque psoriasis,” Sean E. Harper, executive vice president of research and development, Amgen, said in the news release. “This is the first read-out from our phase 3 psoriasis clinical program and we look forward to obtaining additional phase 3 data from our two head-to-head studies versus ustekinumab later this year.”