Amgen, AstraZeneca's brodalumab meets primary endpoints of third Phase III trial in moderate-to-severe plaque psoriasis

Amgen and AstraZeneca announced Tuesday that the experimental monoclonal antibody brodalumab met its primary endpoints of a late-stage study of patients with moderate-to-severe plaque psoriasis versus Johnson & Johnson's Stelara (ustekinumab) and placebo. Briggs W. Morrison, executive vice president of global medicines development at AstraZeneca, said "these results confirm our belief that targeting the IL-17 receptor to inhibit inflammatory signalling can have significant benefit for psoriasis patients."

The AMAGINE-2 trial, which included more than 1800 patients with moderate-to-severe plaque psoriasis assessed the efficacy of brodalumab in reducing the symptoms of plaque psoriasis compared to Stelara and placebo. In the study, patients were randomised to receive brodalumab, at a dose of 140 mg or 210 mg, Stelara or placebo every two weeks for 12 weeks, after which patients in the brodalumab arms were re-randomised to receive one of four different maintenance regimens of the drug.

One primary endpoint of the study was the proportion of patients who received brodalumab 210 mg, as well as a pre-specified weight-based group, who achieved total clearance of skin disease versus baseline, as measured by the Psoriasis Area Severity Index (PASI 100), versus Stelara. Additional primary endpoints were the proportion of brodalumab-treated patients who experienced an at least 75 percent improvement in disease severity compared to baseline (PASI 75) versus Stelara and placebo and the proportion of patients who achieved clear or almost clear skin, as determined using static Physician Global Assessment (sPGA 0 or 1), compared to placebo.

According to the drugmakers, study results showed 44.4 percent of subjects in the brodalumab 210 mg arm and 33.6 percent of patients in the brodalumab weight-based group achieved PASI 100, compared to 21.7 percent of subjects in the Stelara arm. Meanwhile, 86.3 percent of patients in the brodalumab 210 mg group and 77.0 percent of patients in the brodalumab weight-based group achieved PASI 75, versus 70 percent of patients in the Stelara arm and 8.1 percent of patients in the placebo arm.

The AMAGINE programme consisted of three late-stage studies designed to evaluate the safety and efficacy of brodalumab in patients with moderate-to-severe plaque psoriasis. Earlier this month, the drugmakers reported that brodalumab achieved all its primary endpoints of superiority to Stelara and placebo in the AMAGINE-3 Phase III study, while the companies previously announced that the therapy met all of its primary and secondary endpoints compared to placebo in the AMAGINE-1 trial.

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