FDA Approves Otezla for Psoriatic Arthritis

The FDA approved Otezla (apremilast) to treat adults with psoriatic arthritis. The oral drug, manufactured by Celgene Corp., is a phosphodiesterase-4 inhibitor specific for cyclic adenosine monophosphate.

According to an FDA news release, people typically develop psoriasis first before being diagnosed with psoriatic arthritis. Patients with psoriatic arthritis suffer from pain, stiffness, swelling and tenderness of the joints, ligament and tendon inflammation, and a decrease in physical functioning, according to a Celgene news release.

Apremilast is the first oral medication approved to treat psoriatic arthritis. It also has a novel mechanism of action. Other FDA-approved drugs for the disease are corticosteroids, tumor necrosis factor blockers, and an interleukin-12/interleukin-23 inhibitor.

The approval of apremilast was based on the results of 3 multi-center, randomized, double-blind, placebo-controlled trials that included a total of 1493 patients with active psoriatic arthritis who were inadequately treated with disease-modifying anti-rheumatic drugs (DMARDs) and/or biologics.

Compared with patients who received placebo with or without DMARDs, those who took apremilast with or without DMARDs had more improvement in the signs and symptoms of psoriatic arthritis. The authors measured the signs and symptoms using the American College of Rheumatology (ACR) remission criteria and evaluated at least a 20% improvement in tender joint count, swollen joint count, and other measures.

After 16 weeks of treatment, patients in the apremilast group had a reduction in tender and swollen joint counts and each of the 7 ACR components measured compared with the placebo group.

Common side effects associated with apremilast include diarrhea, nausea, and headache. The FDA noted that patients taking apremilast should have their weight monitored on a regular basis. If patients have unexplained or clinically significant weight loss, they should consult with a healthcare professional and should consider stopping treatment.