Apremilast was found to be a safe and effective treatment for adults with genital psoriasis, according to study results published in the Journal of the American Academy of Dermatology.
Researchers conducted DISCREET (ClinicalTrials.gov Identifier: NCT03777436), a phase 3 multicenter, randomized, placebo-controlled, double-blind trial that evaluated the clinical efficacy, impact on quality of life (QOL), and safety of apremilast 30 mg in patients with moderate to severe genital psoriasis. From February 2019 to September 2021, 289 patients were randomly assigned to receive apremilast (n=143) or placebo (n=146). The mean age of patients in the apremilast group was 43.5 years and in the placebo group was 46.4 years. In both groups, 69.9% of patients were men. Demographics and baseline characteristics were similar between the 2 groups. Only 230 patients (apremilast group, 119; placebo group, 111) completed the placebo-controlled period of the trial.
After 16 weeks of treatment, 39.6% of patients in the apremilast group achieved a modified static Physician Global Assessment (sPGA) of Genitalia response (sPGA-G) — marked by a primary endpoint of a 0/1 score or a score reduction of 2 points or more — compared with 19.5% in the placebo group (95% CI, 9.2-30.9; P =.0003). An overall sPGA response at Week 16 was achieved in 22.2% of patients in the apremilast group vs 6.9% of patients in the placebo group (95% CI, 6.9-23.6; P =.0004). Additionally, the Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) response rate was 47.3% and 19.6% in patients in the apremilast vs placebo group, respectively (95% CI, 15.4-39.3; P <.0001).
In addition, there were greater improvements from baseline in involved body surface area (BSA), Dermatology Life Quality Index (DLQI) total score, and Genital Psoriasis Symptoms Scale (GPSS) total score among patients treated with apremilast vs placebo. However, the treatment-emergent adverse event (TEAE) rate was higher among patients in the apremilast (72.0%) vs placebo (57.2%) group from Week 0 to Week 16. Notably, most of the reported TEAEs were nonserious and mild to moderate, including diarrhea, headache, nausea, and nasopharyngitis.
However, 19 patients (10, apremilast; 9 placebo) withdrew from the study due to TEAEs. Of those who withdrew, 5 from the apremilast and 3 from the placebo group did so due to the aforementioned mild to moderate TEAEs, while 3 from the apremilast and 2 from the placebo group did so due to serious TEAEs. No deaths were reported.
Study limitations include its duration, lack of an active comparator, and assessment of the impact of apremilast on sexual function that was limited to only 1 question included in the DLQI survey.
Results from the ongoing extension phase of this trial are anticipated.
The researchers concluded, “Patients who are made aware of convenient, effective treatment options by their physicians may be more inclined to discuss their concerns about [genital psoriasis].”
References:
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. Published online October 16, 2023. doi:10.1016/j.jaad.2023.10.020
