Is Apremilast Efficacious, Safe for Mild-to-Moderate Psoriasis?
Significantly greater response rate seen in static Physician Global Assessment at week 16 for apremilast versus placebo
By Dermsquared Editorial Team | December 29, 2021
Apremilast is efficacious in mild-to-moderate psoriasis, according to a study published in the January issue of the Journal of the American Association of Dermatology.
Linda Stein Gold, M.D., from the Henry Ford Health System in West Bloomfield, Michigan, and colleagues randomly assigned 595 patients with mild-to-moderate psoriasis inadequately controlled or intolerant to one or more topical psoriasis therapies to apremilast or placebo (297 and 298, respectively). Achievement of a static Physician Global Assessment score of 0 (clear) or 1 (almost clear) and ≥2-point reduction at week 16 was the primary end point.
The researchers found that the primary end point was met, with the static Physician Global Assessment response rate significantly greater in the apremilast versus placebo group at week 16 (21.6 versus 4.1 percent). Secondary end points were all met, with significant improvements seen for apremilast in achievement of ≥75 percent improvement in body surface area (33.0 versus 7.4 percent), achievement of body surface area ≤3 percent (61.0 versus 22.9 percent), ≥4-point reduction in the Whole Body Itch Numeric Rating Scale (43.2 versus 18.6 percent), a Scalp Physician Global Assessment 0 or 1 and ≥2-point reduction (44.0 versus 16.6 percent), and changes from baseline in body surface area, the Psoriasis Area and Severity Index, and the Dermatology Life Quality Index. Consistent with prior studies, diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection were the most common adverse events reported with apremilast.
"Apremilast demonstrated clinically meaningful and statistically significant improvements compared with placebo in overall psoriasis severity, scalp psoriasis, and whole body itch," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Amgen, which manufactures apremilast and funded the study.