Guselkumab Led to Improvements in Psoriasis Symptoms, Decreased Sexual Impairment

Sascha Gerdes

Credit: Bionity.com

Psoriasis patients treated with guselkumab may see improvements in their skin symptoms and health-related quality of life (HRQoL) as well as decreases in their disease-influenced sexual impairment and stigmatization, according to new findings.¹

These conclusions resulted from a recent analysis published in the Journal of the European Academy of Dermatology and Venereology in which investigators highlighted the results of the multi-center G-EPOSS study of individuals with moderate-to-severe plaque psoriasis given guselkumab. The drug is a therapeutic monoclonal antibody which targets interleukin(IL)-23.

G-EPOSS was led by Sascha Gerdes, from the Psoriasis Center Kiel of the University Medical Center Schleswig-Holstein’s department of dermatology in Kiel, Germany. Gerdes and colleagues commented on the far greater risk of sexual impairment of those with anogenital psoriasis, as well as the impact on sexuality observed in up to 90% of those with anogenital involvement.²

“The G-EPOSS study evaluates the long-term effectiveness of guselkumab in patients with moderate-to-severe plaque psoriasis, including its effect on skin, nails, the anogenital region and patient-reported outcomes (PROs) in routine clinical practice,” Gerdes and colleagues wrote. “This study provides data beyond traditional routine measures of disease activity and HRQoL, and assesses sexual impairment and perceived stigmatization.”

Background and Methods

The G-EPOSS study had a prospective, multi-center, non-interventional design and involved the recruitment of adult subjects with diagnoses of moderate-to-severe psoriasis within Germany. In the timeframe between October 2019 - August 2021, study subjects were enrolled from 44 different centers and given standard guselkumab treatment 100 mg at Week 0, Week 4, and then over a course every 8 weeks thereafter until the research’s conclusion at the 76-week mark.

Criteria for inclusion in the study comprised of maintaining a baseline Psoriasis Area and Severity Index (PASI) score which was > 3, being age ≥18 years, and being suitable for systemic treatments. Subjects were asked by the research team to complete research questionnaires and were permitted to be on non-biologic, concomitant medications for psoriasis as per routine clinical practice.

The investigators primary aim of their research was to find what the proportion of individuals achieving absolute PASI scores ≤ 3 at the 28-week mark. The research team’s secondary assessments at Week 28 included participants’ anogenital Physician's Global Assessment (aPGA), Nail Psoriasis Severity Index (NAPSI), and Dermatology Life Quality Index (DLQI) scores.

The team determined their secondary endpoints to be Relationship and Sexuality Scale (RSS) assessing patients’ sexual frequency, function, and general fears over the prior 2 weeks, as well as the Perceived Stigmatization Questionnaire (PSQ) which evaluated stigmatization perceptions in several different behaviors. Their evaluations of safety included adverse event (AE) monitoring up to the data cut-off date in April 2022.

Findings

Overall, the research team included 293 participants as the accessible population in their research, with the average subject age being 45.6 years and the average disease duration being 17.6 years. At the study’s initiation, subjects’ average scores on the aPGA, PASI, and DLQI were reported to be 2.7, 15.3, and 11.3, respectively, and around 25.9% of them had used a biologic therapy previously.

Following the end of the 28-week study period, the team found that 83.0% of subjects had a PASI score of 3 or below, and 56.2% and 35.1% reported PASI scores of 1 or 0, respectively. For individuals that had initial NAPSI scores of 1 or greater and aPGA scores of 1 or greater at the study’s initiation, there were 39.2% who reported NAPSI scores of 0, and 61.1% with aPGA scores of 0 by the 28-week mark.

The team also noted 61.4% had reached DLQI scores of 0-1 by the same point in time. Improvements over the course of 28 weeks were reported by the investigators across different elements of the RSS, DLQI, and PSQ, suggesting there had been enhancements in participants’ life quality such as their sexual health and feelings of being stigmatized.

At first, there were 53.6% of subjects who had sexual difficulties identified by DLQI Question 9, though this was shown by the research team to have decreased to 12.1% by the 28-week mark. The team also found that Question 9 responses had been consistent with RSS item responses, indicating that DLQI Question 9 may function as a general indicator for sexual problems.

“The PRO results demonstrate the clinical relevance of Q9 of the commonly used DLQI as a sentinel to trigger further investigations into sexual difficulties or anogenital skin involvement,” they wrote. “Such a holistic approach to patient care may not only positively impact the patient's sense of self-esteem but also the patient's overall degree of social engagement and participation.”

References

1. ^{Gerdes S, Ostendorf R, Süß A, et al. Effectiveness, safety and impact of guselkumab on sexuality and perceived stigmatization in patients with psoriasis in routine clinical practice: Week 28 results from the prospective German multicentre G-EPOSS study. J Eur Acad Dermatol Venereol. Published online April 11, 2024. doi:10.1111/jdv.19927.}
2. ^{Cather JC, Ryan C, Meeuwis K, Potts Bleakman AJ, Naegeli AN, Edson-Heredia E, et al. Patients' perspectives on the impact of genital psoriasis: a qualitative study. Dermatol Ther (Heidelb). 2017; 7: 447–461.}