TOPLINE:

In a phase 3 trial, apremilast 30 mg twice daily produced clinically meaningful, durable improvements in moderate-to-severe genital psoriasis signs, symptoms, and quality of life (QOL) over 32 weeks, with no new safety findings.

METHODOLOGY:

• A phase 3 randomized, double-blind, placebo‑controlled trial (DISCREET) in Belgium, Canada, France, Germany, Italy, and the US evaluated responses to apremilast at 32 weeks in 229 patients (mean age, 45.2 years; 70.3% male) with moderate-to-severe genital psoriasis inadequately controlled with or intolerant to topical therapy, between 2019 and 2022 over 32 weeks.
• Patients received oral apremilast 30 mg twice daily or placebo during a 16-week placebo-controlled phase, followed by a 16-week extension phase in which all patients received apremilast. The extension phase included 110 patients in the placebo/apremilast group and 119 patients in the apremilast/apremilast group.
• The primary endpoint at 32 weeks was the achievement of a modified genital Physician’s Global Assessment (PGA) response defined as clear (score 0) or almost clear (score 1) with at least a 2-point improvement from baseline.
• Secondary outcomes included overall skin severity, genital symptoms such as itch, body surface area (BSA) involvement, and QOL measures.

TAKEAWAY:

• At week 32, 51.8% of patients who switched from placebo to apremilast and 40.3% of those on continuous apremilast had achieved a modified genital PGA response; 29.9% of patients overall achieved full genital skin clearance.
• Overall static PGA response was achieved in 33.6% of patients in the placebo/apremilast group and 30.3% of patients in the apremilast/apremilast group, with sustained reductions in BSA from baseline at week 32 in both groups (mean change, -4.4 and -5.3, respectively).
• Among patients with a baseline Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) ≥ 4, a GPI-NRS response was achieved in 48.4% of patients in the placebo/apremilast group and 46.5% of patients in the apremilast/apremilast group, along with meaningful improvements in Genital Psoriasis Symptoms Scale total scores (mean change from baseline, -25 and -25.7, respectively), indicating reduced genital itch, pain, and discomfort.
• The mean reductions in Dermatology Life Quality Index (DLQI) and DLQI question 9 (asking about how much the skin has caused sexual difficulties in the previous week) were -7.4 and -0.9 in the placebo/apremilast group and -6.1 and -0.7 in the apremilast/apremilast group, respectively, with benefits observed in both sexes (greater QOL improvement in women). The most common adverse events during treatment with apremilast were diarrhea (25.4% of patients), nausea (19.4%), headache (17.9%), and nasopharyngitis (8.3%); serious treatment-related adverse events were reported in one patient.

IN PRACTICE:

“Based on the consistent clinical efficacy, improvements in symptoms, and QOL benefit seen in DISCREET, apremilast appears to be an effective oral therapy in patients with moderate-to-severe genital psoriasis,” the authors of the study wrote. Safety associated with apremilast treatment over the 32 weeks, they added, “remained similar to the primary results and were consistent with the known safety profile of apremilast.”

SOURCE:

The study was led by Joseph F. Merola, MD, Division of Rheumatology, Department of Dermatology, UT Southwestern Medical Center, Dallas, and was published online on December 10 in the Journal of the European Academy of Dermatology and Venereology.

LIMITATIONS:

The study lacked placebo control or an active comparator during the 16-week extension phase. Sexual function assessment was limited to DLQI question 9, without comprehensive sex-specific outcome measures. The predominance of male participants could have affected subgroup analysis results. Additionally, the 32-week duration may not fully reflect long-term treatment outcomes, and the impact of apremilast on inverse psoriasis was not analyzed.

DISCLOSURES:

The study was funded by Amgen. Merola and several authors disclosed receiving consulting and/or investigator fees from multiple pharmaceutical companies, including Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Janssen, Eli Lilly and Company, MoonLake, Novartis, Pfizer, Regeneron, and Sanofi. Detailed disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.