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Amgen, AstraZeneca report Phase II trial results of psoriatic arthritis treatment brodalumab

Amgen and AstraZeneca have reported positive results from a Phase II trial of brodalumab, an investigational treatment, being developed for patients with psoriatic arthritis.

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Brodalumab binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor.

The IL-17 pathway plays a major role in inducing and promoting inflammatory disease processes.

The randomized, double-blind, placebo-controlled Phase II trial showed that treatment with brodalumab improved signs and clinical symptoms associated with the disease, including tender and swollen joints, at 12 weeks as measured by a 20% improvement in the American College of Rheumatology response criteria (ACR20).

In the trial, patients with active psoriatic arthritis were randomized to receive brodalumab (140 or 280mg subcutaneously) or placebo at day 1 and weeks 1, 2, 4, 6, 8, and 10.

According to the company, at week 12, patients were offered open-label brodalumab 280mg every two weeks.

Amgen executive vice president of Research and Development Sean Harper said, "These encouraging psoriatic arthritis data showing that patients not only experienced improvements in clinical symptoms at week 12, but that those improvements continued over time and were sustained, were the basis for our decision to continue development of this molecule as a potential treatment for the many people who are looking to better control their disease."

The trial achieved its primary endpoint with both doses of brodalumab exhibiting superiority to placebo in ACR20 responses at week 12, and these responses continued to improve through 24 weeks and were sustained through the first 52 weeks of the trial.

Both the firms have started two Phase III trials of brodalumab in psoriatic arthritis, AMVISION-1 and AMVISION-2, which together will provide detailed information on the impact of brodalumab on improving clinical signs and symptoms in psoriatic arthritis, as well as its ability to prevent joint damage.


Image: In the Phase II trial, patients with active psoriatic arthritis were given brodalumab (140 or 280mg subcutaneously) or placebo. Photo: courtesy of Baitong333/ freedigitalphotos.net