Amgen (AMGN) and AstraZeneca (AZN) Tuesday announced that AMAGINE-3, 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.
In the trial, 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).
When compared with placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75 percent improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75).
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 (sPGA 0 or 1). 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, 27.0 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 6.0 percent of patients in the placebo group achieved PASI 75.
"Despite a variety of treatment options available for psoriasis, many patients still do not meet skin clearance goals," said Sean Harper, executive vice president of Research and Development at Amgen. "These results are of particular importance as they are the first to demonstrate superiority to Stelara in achieving total skin clearance, and the second positive pivotal Phase 3 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis."
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 1.0 percent for placebo during the placebo-controlled period.
Brodalumab is the only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 cytokines (A, F, A/F and C) to the receptor. The IL-17 receptor and cytokine family play a central role in development and clinical manifestation of plaque psoriasis.
The AMAGINE program is composed of three Phase 3 studies designed to assess the efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis. Top-line results from AMAGINE-1TM, designed to assess the efficacy and safety of brodalumab compared with placebo, were released in May 2014. Detailed results from the AMAGINE-3 study will be submitted to the appropriate scientific forum for presentation and/or publication. Results from AMAGINE-2 are expected by year end.
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