The U.S. Food and Drug Administration approved the drug oral Otezla (apremilast) for adults suffering from active psoriatic arthritis (PsA).
The condition is a form of arthritis that affects some patients with psoriasis, which is usually diagnosed first, the FDA reported.
"Psoriasis is a chronic, autoimmune disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is not contagious," the National Psoriasis Foundation reported.
Psoriasis is the most common autoimmune disease in the U.S. and affects as many as 7.5 million Americans. About 30 percent of people with psoriasis develop PsA.
The main signs and symptoms of PsA include "joint pain, stiffness and swelling." The condition is typically treated with 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 Dr. Curtis Rosebraugh, 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."
Otezla, is an inhibitor of phosphodieasterase-4 (PDE-4). Its safety was assessed in three clinical trials including 1,493 patients with PsA. The medical researchers found the drug helped improve the participants' symptoms, such as swollen joints and mobility, when compared with the placebo. The FDA suggested patients taking the newly-approved drug should have their weight monitored regularly and should consider discontinuing treatment if physicians notice an unexplained drop in weight.
The treatment was associated with a higher rate of depression compared with the placebo. Other symptoms linked to the treatment included "diarrhea, nausea, and headache."
The FDA is requiring a pregnancy exposure registry to assess the risk Otezla may impose on pregnant women.
