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Amgen, AstraZeneca announce positive phase 3 results for plaque psoriasis treatment
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Amgen and AstraZeneca have announced that AMAGINE-2, a multi-arm, phase 3 trial to determine the efficacy of brodalumab in patients with moderate-to-severe plaque psoriasis, met its primary endpoints compared with ustekinumab and placebo at week 12.
In the study, which included more than 1,800 participants with moderate-to-severe plaque psoriasis, patients were given two doses of brodalumab every two weeks via subcutaneous injection, and safety and efficacy were compared with that of Stelara (ustekinumab, Janssen) and placebo. Researchers also assessed the safety and efficacy of four maintenance programs regimens of brodalumab.
The study’s primary endpoint when comparing 210 mg of brodalumab and a prespecified weight-based analysis group with ustekinumab was the proportion of patients who achieved total skin clearance, or Psoriasis Area and Severity Index 100 (PASI 100). The primary endpoint when comparing brodalumab with placebo was the proportion of patients who achieved at least PASI 75 at week 12 and reported clear or almost clear skin by week 12, according to a joint company press release.
The researchers found 44.4% of patients in the brodalumab 210 mg group, 33.6% of patients in the brodalumab weight-based group and 25.7% of patients in the brodalumab 140 mg group achieved total skin clearance, compared with 21.7% of patients in the ustekinumab group and 0.6% of patients in the placebo group.
Additionally, 86.3% of patients in the brodalumab 210 mg group, 77% of the brodalumab weight-based group and 66.6% of the brodalumab 140 mg group achieved PASI 75, compared with 70% of patients in the ustekinumab group and 8.1% of patients in the placebo group.
The most common adverse events to occur in the brodalumab groups were common cold, upper respiratory tract infection, headache and joint pain, according to the release.
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 to the receptor, according to the release.
Reference: www.amgen.com.