Apremilast for Patients with Moderate to Severe Genital Psoriasis

According to a study published in the Journal of the American Academy of Dermatology, apremilast demonstrated statistically and clinically meaningful improvements in genital psoriasis Physician Global Assessment responses.

Researchers aimed to evaluate the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis. The DISCREET trial (NCT03777436), a phase 3, placebo-controlled study, randomized patients with moderate to severe genital psoriasis, stratified by body surface area affected (<10% or ≥10%), to receive either apremilast or placebo for 16 weeks, followed by an extension period for apremilast treatment. The results at week 16 were analyzed.

A total of 289 patients were randomized, with 143 receiving apremilast and 146 receiving placebo. At week 16, 39.6% of patients treated with apremilast achieved a modified static Physician Global Assessment of Genitalia response (a score of 0/1 and a ≥2-point reduction), compared to 19.5% of patients on placebo. This treatment difference of 20.1% was statistically significant (P = .0003). Additionally, apremilast showed significant improvements in genital signs and symptoms, overall skin involvement, and quality of life. Common adverse events associated with apremilast included diarrhea, headache, nausea, and nasopharyngitis.

Apremilast demonstrated statistically and clinically meaningful improvements in genital Physician Global Assessment responses, as well as in the signs, symptoms, severity, and quality of life for patients with genital psoriasis. This represents the first randomized controlled study of an oral systemic treatment for this condition, highlighting apremilast's potential as a viable treatment option.

Reference
Merola JF, Parish LC, Guenther 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):485-493. doi:10.1016/j.jaad.2023.10.020