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Apremilast led to meaningful clinical improvements for patients with genital psoriasis.

Fresh study data, published in the , became available through a trial known as DISCREET, which according to researchers is "the first randomized controlled study of an oral systemic treatment in patients with genital psoriasis using clinical measures of genital psoriasis."

A total of 143 patient participants were randomized to receive apremilast; 146 got placebo. After 15 weeks, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a meaningful clinical response as determined by the Physician Global Assessment (PGA) score. Common treatment-emergent adverse events included diarrhea, headache, nausea, and nasopharyngitis.

The trial was conducted by a multinational team of dermatology clinicians and researchers. The following paper excerpts were edited for length and clarity.

What was the key problem or question this trial was designed to address?

Genital psoriasis affects up to 63% of adults with psoriasis at some time, the research team noted. Common signs and symptoms include itching, pain, discomfort, burning, stinging, redness, scaling, and cracking. The condition also can cause shame, embarrassment, sexual dysfunction, depression, and decreased quality of life.

Further, feelings of shame may contribute to a lack of communication between patients and care providers, often resulting in underreporting, underdiagnosis, or misdiagnosis.

To date, studies on the condition have been limited. Patients whose quality of life is significantly affected may warrant systemic treatment, but no prior studies had tested oral systemic treatments for genital psoriasis.

Apremilast, an oral, immunomodulating phosphodiesterase 4 inhibitor, is approved by the FDA for treating psoriasis across all disease severity levels. DISCREET was a phase 3, multicenter, randomized, placebo-controlled, double-blind study that evaluated the clinical efficacy and safety of apremilast 30 mg twice daily in adults with moderate-to-severe genital psoriasis.

What were the key findings?

The trial demonstrated statistically significant and clinically important treatment differences favoring apremilast, including meaningful improvements in disease severity and symptoms, despite participants having a long disease duration.

More than twice the proportion of patients who received apremilast (39.6%) achieved the trial's primary endpoint -- a score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline -- compared with the placebo group (19.5%) (CI 9.2-30.9, P=.0003).

More than three times as many patients taking apremilast achieved an overall static PGA response at week 16 (22.2%) versus the placebo group (6.9%) (treatment difference: 15.2%; 95% CI 6.9-23.6, P=.0004).

Response rates on the Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) were more robust in the apremilast group (47.3%) versus the placebo group (19.6%) (treatment difference: 27.4%; 95% CI 15.4-39.3, P<.0001).

What were the safety findings for apremilast in the study population?

The treatment-emergent adverse event (TEAE) rate was higher in the apremilast group (72.0%) versus the placebo group (57.2%). Most TEAEs in both treatment groups were considered mild-to-moderate (apremilast: 99.0%; placebo: 91.6%) and nonserious (apremilast: 97.1%; placebo: 97.6%).

The most commonly reported TEAEs were diarrhea, headache, nausea, and nasopharyngitis -- findings consistent with the known safety profile for apremilast. Rates of nasopharyngitis were similar between groups (8.4% vs 8.3%).

What can dermatologists take away from this study?

In a previously published survey of patients with genital psoriasis, nearly half of respondents had not discussed their genital lesions with their physician, more than two-thirds had never been treated, and three-quarters believed their physician did not pay sufficient attention to their genital psoriasis lesions.

Patients who are made aware of convenient, effective treatment options by their dermatologist may be more inclined to discuss their concerns about genital psoriasis, researchers wrote.

The general indication of apremilast for the treatment of mild psoriasis further validates its use in patients with limited skin involvement but psoriasis in areas of high impact, such as genital psoriasis.