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.

Reference:

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