Medication Monitor

Generic Name (Trade Name—Company)
March 25, 2014


(Otezla—Celgene Corp.)
New drug approved for active psoriatic arthritis


Treatment for active psoriatic arthritis in adults

FDA approved apremilast to treat adults with active psoriatic arthritis (PsA).

PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness, and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

Safety and effectiveness of apremilast, an inhibitor of phosphodieasterase-4 (PDE-4), were 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.

Patients treated with apremilast should have their weight monitored regularly by a health professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated, and discontinuation of treatment should be considered. Treatment with apremilast was also associated with an increase in reports of depression compared with placebo.

FDA is requiring a pregnancy exposure registry as a postmarketing requirement to assess the risks to pregnant women related to apremilast exposure.
In clinical trials, the most common adverse effects were diarrhea, nausea, and headache.