Apremilast improves symptoms, QoL in patients with genital psoriasis

Treatment with apremilast results in a significant reduction in genital psoriasis (G-PsO), as well as improvements in itch, pain, discomfort, redness, and quality of life (QoL), in patients with moderate-to-severe G-PsO who are intolerant to topical therapies, a study has shown.

In addition, apremilast demonstrates an acceptable safety profile, with adverse events (AEs) consistent with the known safety profile.

“Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and QoL in this first randomized, controlled study of an oral systemic treatment in patients with G-PsO,” the investigators said.

A phase III, placebo-controlled trial (DISCREET) randomly assigned patients with moderate-to-severe G-PsO (stratified by affected body surface area: <10 percent or ≥10 percent) to receive either apremilast (n=143) or placebo (n=146) for 16 weeks, followed by an extension period.

Of the participants, 39.6 percent of apremilast-treated patients and 19.5 percent of those on placebo achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction) at week 16. The treatment difference was 20.1 percent, which was deemed significant (p=0.0003). [J Am Acad Dermatol 2024;90:485-493]

Significant improvements in genital signs and symptoms (ie, itch, pain, discomfort, stinging, and burning), skin involvement (ie, redness, scaling, and cracking), and QoL were also observed. Common treatment-emergent AEs included nausea, diarrhoea, headache, and nasopharyngitis.

These findings, however, were limited by the absence of an active comparator and short study duration, according to the investigators.

Stigmatizing

“G-PsO is associated with severely impaired QoL,” the investigators said. “It significantly impacts sexual health, function, and relationships.” [J Am Acad Dermatol 2015;72:978-983]

In addition, G-PsO is often undiagnosed and untreated. A survey of patients with this condition found that almost half had not discussed their genital lesions with their physician, more than two-thirds had never received treatment, and three-quarters thought their physician did not pay sufficient attention to their lesions. [Dermatology 2012;224:271-276]

“Despite a wide range of therapeutic options for psoriasis, few treatments have been studied specifically in patients with G-PsO or have supportive data for use in this population,” the investigators said.

“Apremilast has demonstrated efficacy in other special areas, such as the scalp, nails, and palmoplantar areas,” they added. [J Am Acad Dermatol 2020;83:96-103; Dermatol Ther (Heidelb) 2022;12:1469-1480; Dermatol Ther (Heidelb) 2022;12:81-95; J Eur Acad Dermatol Venereol 2023;37:348-355]

Prior to apremilast, the only systemic treatment with data on efficacy in the treatment of G-PsO was ixekizumab. [Br J Dermatol 2018;179:844-852; J Sex Med 2018;15:1645-1652; Acta Derm Venereol 2020;100:adv00006]

“Results from DISCREET show that apremilast, an oral agent approved across psoriasis disease severities, is a promising, unique treatment option for patients with moderate-to-severe G-PsO,” according to the investigators.

Notably, “G-PsO may be the most stigmatizing form of psoriasis, affecting up to 63 percent of adults with psoriasis at some time,” they noted. [Acta Derm Venereol 1999;79:443-447; J Am Acad Dermatol 2015;72:978-983]