Apremilast Approved for Psoriatic Arthritis

VBCR - April 2014, Volume 3, No 2 - FDA Approvals, News & Updates

The US Food and Drug Administration approved the use of apremilast (Otezla), a phosphodiesterase-4 inhibitor, on March 21, 2014, for the treatment of adults with active psoriatic arthritis.

Most people develop psoriasis first and are later diagnosed with psoriatic arthritis. Joint pain, stiffness and swelling are the main signs and symptoms of psoriatic arthritis.

Three clinical trials (N = 1493) evaluated the safety and effectiveness of apremilast in this patient population. Patients treated with the drug showed improvements in signs and symptoms of psoriatic arthritis including tender and swollen joints, as well as physical function compared with placebo.

The FDA noted that patients treated with apremilast should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered. Apremilast was also associated with an increase in depression compared with placebo. Common side effects observed in patients taking the drug were diarrhea, nausea, and headache.

In addition, the US Food and Drug Administration is requiring a pregnancy exposure registry as a postmarketing requirement to assess the risks to pregnant women related to apremilast exposure.

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