The FDA has announced its approval of the drug Otezla (apremilast) for the treatment of active psoriatic arthritis (PsA) in adults following three clinical trials involving mearly 1,500 patients, which showed that it was effective in improving symptoms such as tender and swollen joints and overall physical function. The most common side-effects associated with Otezla were reported to be diarrhea, nausea, and headache, as well as an increase in depression.
PsA is a form of inflammatory arthritis found in up to 30% of patients already suffering from psoriasis.and is characterized by joint pain, stiffness and swelling. Additional symptoms may include Pain, swelling, or stiffness in one or more joints, which become red or warm to the touch; sausage-like swelling in the fingers or toes, known as dactylitis; pain in and around the feet and ankles, especially tendinitis in the Achilles tendon or Plantar fasciitis in the sole of the foot; pitting in nails or separation from the nail bed; and pain in the lower back, (above the tailbone); as well as extreme exhaustion even when well rested.
Approved treatments for PsA currently include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.
“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”
Despite its approval, the FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure and isrecommending that patients treated with Otezla have their “weight monitored regularly by a healthcare professional lest they suffer unexplained or clinically significant weight loss.”
For more information about this or any other FDA approved drugs readers can contact the agency by calling 888-INFO-FDA.