The following is a summary of “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,” published in the March 2024 issue of Dermatology by Merola, et al.

Genital psoriasis, prevalent among psoriasis patients, poses significant challenges due to limited treatment options and potential stigma. Apremilast, an oral immunomodulating phosphodiesterase 4 inhibitor, is approved for psoriasis management. For a study, researchers sought to evaluate the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis.

The DISCREET trial, a phase 3, placebo-controlled study (NCT03777436), randomized patients with moderate-to-severe genital psoriasis to receive either apremilast or placebo for a 16-week period, followed by an apremilast extension phase. Week 16 results were analyzed.

Patients were randomized to receive apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% of apremilast-treated patients achieved a modified static Physician Global Assessment of Genitalia response compared to 19.5% in the placebo group, demonstrating a significant treatment difference (20.1%, P = .0003). Apremilast treatment also improved genital signs and symptoms, skin involvement, and quality of life. Everyday treatment-emergent adverse events included diarrhea, headache, nausea, and nasopharyngitis. The study lacked an active comparator, limiting direct comparisons.

Apremilast exhibited statistically and clinically significant improvements in genital Physician Global Assessment responses and enhancements in signs, symptoms, severity, and quality of life. The study represented the first randomized, controlled investigation of an oral systemic treatment for genital psoriasis, highlighting the potential of apremilast in this patient population.

Reference: jaad.org/article/S0190-9622(23)03022-0/fulltext