practicaldermatology.com
Apremilast was efficacious in reducing the symptoms of genital psoriasis (G-PsO) in patients who didn't respond to topical treatments or who were not adequately controlled by topical therapy, new research indicates.
DISCREET aimed to evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor. The randomized, double-blind, placebo-controlled study included patients randomized 1:1 to receive either apremilast 30 mg twice daily (BID; n=143) or placebo (n=146) for 16 weeks. Patients were stratified based on baseline psoriasis-affected body surface area (BSA) and were allowed to use unmedicated emollients and nonmedicated shampoos during the study. The primary efficacy endpoint was the proportion of patients achieving a modified genital Physician Global Assessment (PGA) response at week 16, with secondary endpoints of overall sPGA response, Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) response, changes in affected BSA, and changes in patient-reported outcomes such as Dermatology Life Quality Index (DLQI) and Genital Psoriasis Symptom Scale (GPSS).
According to the results of the analysis, apremilast significantly improved G-PsO compared to placebo, with more than twice the proportion of patients achieving a modified genital PGA response at week 16. Secondary endpoints also favored apremilast. Safety assessments showed a higher incidence of treatment-emergent adverse events (TEAEs) with apremilast vs. placebo, with gastrointestinal events being the most common. Most TEAEs were mild-to-moderate and nonserious, however, which was consistent with the known safety profile of apremilast.
"Apremilast significantly reduced G-PsO, including clinical findings (ie, itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) and improved quality of life, in patients with moderate-to-severe G-PsO who were inadequately controlled by or intolerant to topical therapies," the authors wrote in the study. "Apremilast had acceptable safety, with adverse events consistent with the known safety profile."
Source: Merola J, Parish L, Gunther L, et al. Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2024;90(3):P485-493. doi.org/10.1016/j.jaad.2023.10.020