Phase III trial of AMG 827 meets endpoints in Plaque Psoriasis-AstraZeneca/Amgen

AMAGINE-3, a pivotal, multi-arm Phase III trial evaluating two doses of AMG 827 (brodalumab), from AstraZeneca and Amgen, in more than 1,800 patients with moderate-to-severe Plaque Psoriasis, met its primary endpoints when compared with both Stelara (ustekinumab) and placebo at week 12. Brodalumab was shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI 100). All key secondary endpoints comparing brodalumab with Stelara and placebo were also met. Results showed that 36.7 percent of patients in the brodalumab 210 mg group, 27 percent of patients in the brodalumab 140 mg group, 18.5 percent of patients in the Stelara group and 0.3 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100).

In addition, 85.1 percent of patients in the brodalumab 210 mg group, 69.2 percent of patients in the brodalumab 140 mg group, 69.3 percent of patients in the Stelara group and 6 percent of patients in the placebo group achieved PASI 75. The most common adverse events that occurred in the brodalumab arms (more than 5 percent of patients in either group) were common cold, joint pain, upper respiratory tract infection and headache. Serious adverse events occurred in 1.4 percent of patients in the 210 mg group and 1.6 percent of patients in the 140 mg group compared with 0.6 percent for Stelara and 1 percent for placebo during the placebo-controlled period. Detailed results from the AMAGINE-3 study will be submitted to the appropriate scientific forum for presentation and/or publication.