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By J Michael Maloney MD
October 07, 2014
Category: Skin News
Tags: Psoriasis   Drugs   drug   treatment  

New Drug for Psoriasis:

Apremilast approval expanded to include plaque psoriasis

By: ELIZABETH MECHCATIE, Skin & Allergy News Digital Network

September 24, 2014

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

Celgene markets apremilast as Otezla.The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.



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