Brodalumab Meets Primary Endpoint in Plaque Psoriasis Trial

Amgen and AstraZeneca announced results from the Phase 3 AMAGINE-2 study evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis. Brodalumab binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor.

AMAGINE-2 assessed the safety and efficacy of brodalumab compared to Stelara and placebo in patients with moderate-to-severe plaque psoriasis. The study also assessed the safety and efficacy of four maintenance regimens of brodalumab. The primary endpoint comparing 210mg of brodalumab as well as a pre-specified weight-based analysis group with Stelara was the proportion of patients achieving total clearance of skin disease, as measured by Psoriasis Area Severity Index (PASI 100) at week 12. When comparing brodalumab with placebo, the primary endpoints included the proportion of patients achieving at least a 75% improvement from baseline in disease severity (PASI 75) at week 12, and the achievement of clear or almost clear skin, according to the sPGA (0 or 1) at week 12.

Results demonstrated that the primary endpoint in this study was met. Brodalumab 210mg given every two weeks and the brodalumab weight-based analysis group were each shown to be superior to Stelara on the primary endpoint of achieving total clearance of skin disease. When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12. A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo.

Results showed that 44.4% of patients in the brodalumab 210mg group, 33.6% of patients in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved total clearance of skin disease (PASI 100). In addition, 86.3% of patients in the brodalumab 210mg group, 77% of patients in the brodalumab weight-based group, 66.6% of patients in the brodalumab 140mg group, 70% of patients in the Stelara group and 8.1% of patients in the placebo group achieved PASI 75.

Want to read more?