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Efficacy and Safety of Apremilast in Plaque Psoriasis


A phase 3 study evaluated apremilast as a treatment for patients with mild to moderate psoriasis.

Apremilast (Otezla; Amgen) 30-mg twice daily was examined as a treatment for mild to moderate psoriasis in a recent phase 3, double-blind, placebo controlled study (NCT03721172), published in the Journal of the American Academy of Dermatology.1 

The study investigated adults with mild to moderate psoriasis inadequately controlled or intolerant to 1 or more topical psoriasis therapies. The primary endpoint was the achievement of static Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) and 2 or more-point reduction at week 16.

In total, 595 patients were randomized in to apremilast (297 patients) or placebo (298 patients). The primary endpoint was met at week 16 with a significantly greater static PGA response rate observed in the apremilast group vs the placebo group (21.6% vs 4.1%; P < .0001). 

All of the secondary endpoints were met with the achievement of body surface area (BSA)-75 (33.0% vs 7.4%), BSA less than or equal to 3% (61.0% vs 22.9%), greater than or equal to 4-point reduction in Whole Body Itch Numeric Rating Scale (WBINRS) (43.2% vs 18.6%), Scalp PGA 0 or 1 and 2 or more-point reduction (44.0% vs 16.6 %), and changes from baseline in BSA, Psoriasis Area and Severity Index (PASI), and Dermatology Life Quality Index (DLQI) (all P < .0001).

The adverse events (AEs) that were most reported (greater than or equal to 5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies. 

This study was limited because to the lack of an active-comparator arm.

“Apremilast demonstrated efficacy in mild to moderate psoriasis and safety consistent with the established safety profile of apremilast,” the authors concluded.


1. Gold LS, Papp K, Pariser D, et al. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Journal of the American Academy of Dermatology. 2021;0(0). doi:10.1016/j.jaad.2021.07.040

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