FDA approves oral drug for psoriatic arthritis

March 25, 2014

The Food and Drug Administration has approved an oral medication, Otezla (apremilast, Celgene) for the treatment of adult patients with active psoriatic arthritis.

 

The Food and Drug Administration has approved an oral medication, Otezla (apremilast, Celgene) for the treatment of adult patients with active psoriatic arthritis.

Otezla, which inhibits phosphodieasterase-4 (PDE4), was evaluated in three clinical trials of 1,493 patients with psoriatic arthritic to determine its safety and efficacy. Patients treated with the drug demonstrated improvements in the signs and symptoms of psoriatic arthritis, such as swollen and tender joints, compared to patients who were given a placebo.

In the first study, 38 percent of patients who received Otezla 30 mg twice daily achieved an ACR 20 response at week 16, versus 19 percent of the patients given placebo. Results were consistent in phase 2 and 3 studies, Celgene reported. Improvements in ACR 50 and ACR 70 responses were observed at week 16 in all three studies.

“Otezla works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4,” Philip Mease, M.D., director of the rheumatology clinical research division of Swedish Medical Center, and clinical professor, University of Washington, Seattle, said in a news release.

Current therapies available for patients with psoriatic arthritis include tumor necrosis factor inhibitors, an interleukin-12/23 inhibitor and corticosteroids.

“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II at the FDA’s Center for Drug Evaluation and Research, said in a news release. “Otezla provides a new treatment option for patients suffering from this disease.”

Common adverse events included nausea, headache, diarrhea, vomiting, upper respiratory tract infection, upper abdominal pain and nasopharyngitis. Most reactions occurred within the first two weeks of treatment and tended to resolve after a period of time with continued dosing. The proportion of patients who discontinued Otezla 30 mg twice daily due to adverse reactions was 4.6 percent, compared to 1.2 percent for patients given placebo.

The FDA is requiring a pregnancy exposure registry as a post-marketing requirement, in order to assess risks to pregnant women related to Otezla exposure.