A Phase 3 clinical trial, called AMAGINE-2, evaluating three doses of brodalumab (Amgen/AstraZeneca) in patients with moderate to severe plaque psoriasis successfully met its key primary and secondary endpoints when compared to Stelara (ustekinumab) and placebo at week 12.
Brodalumab, a human monoclonal antibody, targets and binds to the interleukin-17 (IL-17) receptor and blocks several IL-17 cytokines (A, F and A/F) from binding there, inhibiting inflammation. It is also being investigated for the treatment of psoriatic arthritis and asthma.
The plaque psoriasis study involved more than 1,800 patients separated into five groups—placebo, Stelara, 210mg brodalumab given every two weeks, 140mg brodalumab given every two weeks, and weight-based brodalumab dosage. The weight-based and 210mg doses of brodalumab were found to be superior to Stelara and the placebo in achieving total clearance of the skin as measured by the Psoriasis Area Severity Index (PASI 100). Of the five groups, 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% in the brodalumab weight-based group, 66.6% in the brodalumab 140mg group, 70% in the Stelara group and 8.1%of patients in the placebo group achieved PASI 75.
Common adverse events included upper respiratory infection, joint pain, common cold and headache; serious adverse events occurred in 1% to 2% of brodalumab patients depending on dosage group.
“These results confirm our belief that targeting the IL-17 receptor to inhibit inflammatory signaling can have significant benefit for psoriasis patients,” said Briggs W. Morrison, MD, executive vice president of global medicines development at AstraZeneca. “We look forward to sharing detailed results from the AMAGINE program in upcoming scientific forums.”