Amgen and AstraZeneca announced that AMAGINE-2TM, a pivotal, multi-arm Phase 3 trial evaluating two doses of brodalumab 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 210 mg 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, as measured by the Psoriasis Area Severity Index. 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, as measured by the Psoriasis Area Severity Index. A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment.
Results showed that 44.4% of patients in the brodalumab 210 mg group, 33.6% of patients in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140 mg 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 210 mg group, 77.0% of patients in the brodalumab weight-based group, 66.6% of patients in the brodalumab 140 mg group, 70.0% of patients in the Stelara group and 8.1% of patients in the placebo group achieved PASI 75.
“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% improvement in their disease,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “AMAGINE-2 is the third and final pivotal study in our Phase 3 psoriasis program and the robust data from these studies will form the basis of our global filing plan. We look forward to discussions with regulatory authorities.”
Source: Amgen
