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Brodalumab Superior to Ustekinumab (Stelara) in Pivotal Psoriasis Study
AMAGINE-3, a pivotal phase III trial evaluating two doses of brodalumab (AstraZeneca/Amgen) in more than 1,800 patients with moderate-to-severe plaque psoriasis, has met its primary endpoints compared with both ustekinumab (Stelara, Janssen Biotech) and placebo at week 12.
Brodalumab was shown to be superior to ustekinumab on the primary endpoint of achieving 100% clearance of skin disease, as measured by the Psoriasis Area Severity Index (PASI) 100. 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 PASI 75. A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo (a score of 0 or 1 on the static Physician Global Assessment [sPGA]). All key secondary endpoints comparing brodalumab with ustekinumab and placebo were also met.
The results showed that 36.7% of patients receiving brodalumab 210 mg; 27.0% of patients receiving brodalumab 140 mg; 18.5% of patients receiving ustekinumab; and 0.3% of patients receiving placebo achieved total clearance of skin disease (PASI 100). In addition, 85.1% of the brodalumab 210-mg group; 69.2% of the brodalumab 140-mg group; 69.3% of the ustekinumab group; and 6.0% of the placebo group achieved PASI 75.
The most common adverse events in the brodalumab arms included the common cold, joint pain, upper respiratory tract infection, and headache. Serious adverse events occurred in 1.4% of the 210-mg group and in 1.6% of the 140-mg group compared with 0.6% and 1.0% of the ustekinumab and placebo groups, respectively, during the placebo-controlled period.
Brodalumab is an investigational treatment 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 the development and clinical manifestation of plaque psoriasis.
Source: AstraZeneca; November 11, 2014.