FDA approves apremilast to treat adults with psoriatic arthritis

The FDA announced today it has approved apremilast to treat adults with active psoriatic arthritis.

Apremilast (Otezla, Celgene Corp.) is a phosphodiesterase-4 inhibitor. Approval was based on three clinical trials studying 1,493 patients with active psoriatic arthritis (PsA), according to an FDA news release. Patients treated with apremilast displayed improvements in disease signs and symptoms, including tender and swollen joints and physical function, when compared with placebo-treated patients.

“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active [PsA], Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research said in the release. “Otezla provides a new treatment option for patients suffering from this disease.”

Corticosteroids, tumor necrosis factor inhibitors and an interleukin-12/interleukin-23 inhibitor are other approved treatments for PsA.

The FDA warned that patients who are treated with apremilast should have their weight monitored by a health care professional, and if “unexplained or clinically significant weight loss” occurs, the weight loss should be evaluated, with possible discontinuation of treatment. Reports of depression also were reported in patients treated with apremilast compared with those treated with placebo.

To assess the risks to pregnant women related to apremilast exposure, the FDA is requiring that a pregnancy exposure registry be a post-marketing requirement.

Diarrhea, nausea and headache were the most common reported side effects in the clinical trials.