Apremilast Leads to Consistent Benefits Among Patients with Genital Psoriasis

Joseph Merola, MD, MMSc/Credit: Twitter (X)

Individuals treated with oral apremilast for genital psoriasis may experience consistent benefits of this treatment, according to recent findings, with improvements in sexual health, life quality, and overall psoriasis skin clearance.¹

The study was titled ‘Effects of Apremilast on Quality of Life and Skin Clearance in Men and Women With Genital Psoriasis: Subgroup Analysis From the Phase 3 DISCREET Study,’ and was led by Joseph F. Merola, MD, MMSc, from the Brigham and Women’s Hospital at Harvard Medical School. This subgroup analysis was drawn from the aforementioned DISCREET study (NCT03777436).

This analysis was conducted with the aim of evaluating the impact of apremilast and it was presented at Maui Derm NP+PA Fall 2024.

“Apremilast is an oral immunomodulating phosphodiesterase 4 inhibitor approved for the treatment of plaque psoriasis,” Merola and colleagues wrote. “Using genital specific outcome measures, this analysis evaluated the efficacy of apremilast in men and women with genital psoriasis from DISCREET.”

Trial Design and Background

The condition of genital psoriasis is known to be a particularly stigmatizing one which is often underdiagnosed and is often undertreated. The disease is known to impact up to 63% of those with psoriasis at some point in the course of their condition, not only resulting in physical discomfort but also major quality of life and sexual health impairments.

Women specifically are known to often experience more severe symptoms versus men. The investigators highlighted the fact that women are also less likely to take part in sexual activity and are therefore less frequently given a diagnosis or treatment of genital psoriasis.

DISCREET was a phase 3, placebo-controlled, randomized, double-blind clinical study , designed to assess the apremilast 30 mg’s efficacy at a twice-per-day dose over the course of 16 weeks. Those evaluated had moderate to severe genital psoriasis, which was defined by the team as having a modified static Physician Global Assessment of Genitalia (sPGA-G) score of 3 or higher.

Prior findings from this particular study had indicated that the drug led to substantially improved symptoms of genital psoriasis, including pruritus, skin appearance, and life quality among individuals who had not shown positive response to topical therapies or those who were intolerant of such drugs.

In the investigators’ post-hoc analysis of DISCREET, further assessments of distinctions between male and female subjects with regard to shifts in their scores on the Dermatology Life Quality Index (DLQI) and Dermatology Life Quality Index (DLQI) question 9, which asks respondents about sexual issues. The analysis also looks at response rates based on the sPGA-G and at subjects’ overall sPGA scores.

There were 289 individuals enrolled in the analysis, with 202 men and 87 women. Severe genital psoriasis at the point of baseline was observed among more men than women, though women had higher mean baseline DLQI scores. This latter observation denoted a greater effect on life quality for women despite both cohorts reporting substantial effects.

Major Findings on Apremilast

Apremilast was shown by the 16-week mark to have led to greater DLQI Q9 score improvements versus those given a placebo, with the research team finding that the least-squares (LS) mean changes of −0.27 among those in the cohort of men and −0.41 in the cohort of women. They did add, however, that the improvements seen among women narrowly missed the criteria for statistical significance.

In a similar vein, the investigators found that improvements to DLQI total scores were shown to be greater among those in the apremilast groups, adding that LS mean differences of −2.62 were observed for men and −2.78 for women. An increased percentage of both men and women given apremilast therapy were noted as having improved significantly in sPGA-G and overall sPGA scores by the 16-week mark.

The team specifically concluded that 35.7% of men and 48.7% of women given apremilast therapy were successful in achieving a modified sPGA-G response, versus 18.6% and 21.6% for those in the placebo arms, respectively. In terms of overall sPGA scores, the investigators noted that 20.5% of men and 26.7% of women given the drug were successful in their achievement of a clear or almost clear score, versus 4.1% and 13.5% on placebo, respectively.

“Men and women treated with apremilast, the first oral systemic treatment studied for genital psoriasis, experienced consistent treatment benefits, including improved sexual health and QoL, and achievement of genital and overall psoriasis skin clearance,” they wrote. “While sample size for female patients was lower, results are notable as women with genital psoriasis often experience higher disease burden than men.”

References

1. ^{Merola J, Parish L, Papp K, et al. Effects of Apremilast on Quality of Life and Skin Clearance in Men and Women With Genital Psoriasis: Subgroup Analysis From the Phase 3 DISCREET Study. Presented at: Maui Derm NP+PA Fall 2024. Nashville, TN. September 15-18, 2024.}