The safety and effectiveness of apremilast, a phosphodieasterase-4 inhibitor, was evaluated in three clinical trials involving 1,493 patients with active PsA.
Patients treated with apremilast showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared with placebo.
The agency cautioned that patients treated with apremilast should have their weight monitored regularly by a health care professional, and treatment should be discontinued if unexplained or clinically significant weight loss occurs.
The most common side effects observed in clinical trials were diarrhea, nausea, and headache, along with an increased rate of depression compared with placebo, according to an FDA press release.
To assess the risks to pregnant women related to apremilast exposure, the manufacturer will maintain a pregnancy exposure registry as a post-marketing requirement.
“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”
Prior to the approval of apremilast, treatments for PsA included only corticosteroids, tumor necrosis factor blockers, and an interleukin-12/interleukin-23 inhibitor.