Researchers have found in a new study that Apremilast demonstrated sustained and clinically meaningful improvements in genital psoriasis signs and symptoms, along with significant enhancement in patients’ quality of life, through 32 weeks of treatment. The study also confirmed a consistent and acceptable safety profile over the treatment period, supporting apremilast as an effective long-term therapeutic option for genital psoriasis. The study was published in JEADV by Joseph F. and colleagues.
Genital psoriasis is very common in patients with psoriasis and is often painful, itchy, and uncomfortable, thus deeply affecting physical, psychological, and sexual quality of life. However, symptoms related to genital psoriasis are mostly stigmatizing and sensitive; therefore, the disease is underreported and undertreated. Apremilast is an oral phosphodiesterase 4 inhibitor approved for the treatment of psoriasis that had already demonstrated safety and efficacy in genital psoriasis during the primary 16-week placebo-controlled phase of DISCREET.
DISCREET was a phase 3, multicentre, randomized, double-blind clinical trial that investigated apremilast 30 mg twice daily versus placebo. It consisted of a 16-week placebo-controlled period with 1:1 randomization, followed by a 16-week open-label extension with apremilast, bringing the total duration of the study to 32 weeks. Patients eligible for participation in the study had moderate to severe genital psoriasis, as defined by a modified static Physician’s Global Assessment of Genitalia (genital PGA) score ≥3.
All participants had a disease that was inadequately controlled by topical therapy or were intolerant to topical treatment. Overall, 289 patients were randomized in the placebo-controlled period. Of these, 229 continued into the extension with apremilast from Weeks 16 to 32, which comprised 110 patients who switched from placebo to apremilast and 119 patients who continued with their initial apremilast treatment given at randomization.
Key findings
The percentage of patients who achieved a modified genital PGA response, defined as a score of 0 or 1 with at least a 2-point decrease from baseline, was the main efficacy outcome evaluated through Week 32.
A modified genital PGA response was attained by 51.8% of patients in the placebo-to-apremilast group at Week 32, with a 95% CI of 42.6% to 60.9%.
40.3% of patients in the apremilast-to-apremilast group experienced a response, with a 95% CI of 32.0% to 49.3%.
The most common adverse events were headache (17.9%), nausea (19.4%), and diarrhea (25.4%).
Apremilast demonstrated consistent clinical efficacy, symptom reduction, and quality-of-life improvement in patients with moderate to severe genital psoriasis through 32 weeks of treatment in the DISCREET trial. These findings support apremilast as a valuable oral systemic treatment option for this high-burden and often under-treated manifestation of psoriasis.
Reference:
Merola, J. F., Guenther, L., Lynde, C., Papp, K. A., Parish, L. C., Yamauchi, P., Cheng, S., Amouzadeh, H., Deignan, C., Jardon, S., Chen, M., & Pinter, A. (2026). Results from the 32-week, phase 3 DISCREET study of apremilast in patients with moderate to severe genital psoriasis. Journal of the European Academy of Dermatology and Venereology, 40(2), 274–284. https://doi.org/10.1111/jdv.70110
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