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    Apremilast, first-in-class treatment option for plaque psoriasis

    Kathryn WheelerIn September, FDA approved Apremilast (Otezla; Celgene) for treatment of moderate-to-severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy. Apremilast was first approved by FDA for treatment of adults with active psoriatic arthritis in March 2014. The first of a new class of drug therapy for these conditions, apremilast is a phosphodiesterase 4 (PDE4) inhibitor. It reduces the inflammatory processes associated with these conditions, resulting in symptom improvement. For patients with moderate-to-severe plaque psoriasis, apremilast offers a new oral option for treatment.


    Apremilast was approved for treatment of moderate-to-severe plaque psoriasis on the basis of two randomized, double-blind, placebo-controlled trials (ESTEEM 1 and 2). Participants were at least 18 years of age with moderate-to-severe plaque psoriasis and were were candidates for phototherapy or systemic therapy.

    In both studies, participants were randomized to receive either apremilast 30 mg twice daily or placebo for 16 weeks. The primary endpoint in both studies was the proportion of participants achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI-75). At week 16, 5% of participants taking placebo achieved PASI-75 in each trial compared to 33% (ESTEEM-1) and 28% (ESTEEM-2) of participants taking apremilast. The static Physician Global Assessment (sPGA) scores of “clear” or “almost clear” were assessed as a secondary endpoint.

    Both studies demonstrated greater achievement of significantly improved sPGA scores with apremilast use at 16 weeks compared to placebo (21.7% vs. 3.9% in ESTEEM-1; 20.4% vs. 4.4% in ESTEEM-2). Study findings were deemed significant and clinically meaningful improvements in plaque psoriasis. While apremilast provides a therapeutic option for treatment of psoriasis, its efficacy has not been studied in comparison with other approved treatment options.

    Kathryn Wheeler, PharmD, BCPS
    Kathryn Wheeler, PharmD, BCPS, is assistant clinical professor of pharmacy practice, University of Connecticut School of Pharmacy, ...


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