The FDA has announced the approval of Otezla (apremilast) for the treatment of active psoriatic arthritis in adults. Otezla is an inhibitor of phosphodiesterase-4 (PDE-4). PDE4 inhibition results in increased intracellular cAMP levels (cyclic adenosine monophosphate).
The safety and effectiveness of the drug was evaluated in three clinical trials (PALACE 1, 2, and 3) involving 1,493 patients with active psoriatic arthritis. Compared to placebo, study participants treated with Otezla showed improvement in signs and symptoms, including tender and swollen joints and physical function.
Patients taking Otezla should watch for signs of unexplained weight loss or depression. Common side effects included diarrhea, nausea, and headache. The oral drug is manufactured by Celgene. Availability in the U.S. is expected to be in March 2014 through a network of specialty pharmacies. Look for more information at otezla.com.
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