Guselkumab Effective as Treatment for Facial, Genital Psoriasis

Guselkumab is an efficacious and safe option for treatment of facial psoriasis and genital psoriasis, according to recent findings, and the drug may be considered a valid therapeutic option for individuals that have psoriasis in such difficult-to-treat regions.¹

These conclusions resulted from new research led by Claudio Bonifati, from the department of clinical dermatology at San Gallicano Dermatological Institute, IRCCS, in Rome, Italy. Bonifati et al. noted that treating facial and genital psoriasis continues to be a major unmet need among patients, with limited treatments available and a general lack of data regarding efficacy of therapies.²

To address this unmet need, the investigators sought to assess the use of guselkumab among such patients, the drug being an interleukin (IL)-23 inhibitor that has been shown to be helpful in treatment of moderate-to-severe plaque psoriasis patients.

“The GULLIVER study is a large 52-week observational, noninterventional study that aims to evaluate the effectiveness and safety of guselkumab in daily clinical practice on patients with FP and/or GP,” Bonifati and colleagues wrote. “Herein, we present the results of the interim analysis of data from the overall GULLIVER study population of 351 patients at 12 weeks after initiating guselkumab treatment.”¹

Background and Design

The investigators’ interim analysis was conducted during the GULLIVER study, an ongoing observational research study carried out within several different centers located in Italy. The team sought to evaluate guselkumab, including data on its impact on life quality, safety signals, and satisfaction among psoriasis patients with substantial involvement of the genital and/or facial areas.

The administration of guselkumab 100 mg to study participants was done through a subcutaneous injection given at the 0 and 4-week marks. This was then followed by an injection every 8 weeks up until the 52-week mark.

Enrollment of subjects could take place at any point between the first injection at Week 0 and prior to a subject’s subsequent visit in Weeks 4 or 12. This would follow the typical clinical routines.

The research team’s use of guselkumab was done based upon standard clinical practice guidelines rather than study protocols. The Week 0 information was gathered retrospectively, while data regarding Weeks 12, 28, and 52 was collected prospectively.

By the study’s initiation, data on patients' clinical response measures, characteristics, and patient-reported outcomes were taken down by the investigators. A total of 38 dermatological centers around Italy were implemented for the team’s research.

Those who were recruited for the study included individuals with facial psoriasis and/or genital psoriasis who were shown to have had a static Physician Global Assessment (sPGA) score of 3 or more in either or both of the aforementioned regions of their body. If an individual was noted as having severe symptoms in both of these regions, the investigators assigned them to the cohort in which the condition was labeled severe.

The research team’s key goal in their interim analysis was to find the percentage of participating subjects who could achieve an sPGA score of 0 (clear) or 1 (almost clear) within the facial or genital regions that had been affected, and this would have to occur by Week 12. They also assessed sPGA score shifts for those who first reported a score of 3 or more, evaluating subjects’ Psoriasis Area and Severity Index (PASI) scores for subjects showing baseline PASI scores above or below 10.

Findings

There were 351 participants in total included in this analysis. Among the subjects, the investigators reported that 83.3% of subjects with facial psoriasis and 76.5% with genital psoriasis were able to reach the study’s main endpoint. Within the sPGA components, these improvements were observed by the team among participants that had scores of 3 or higher at baseline in the affected regions.

Within the group whose baseline PASI scores were found by the research team to have been greater than 10, a decrease of average PASI scores from 19.0 (SD 8.3) to 2.2 (SD 4.8) was reported. The team also expressed that 44 adverse events had been observed among 32 individuals.

Specifically, they wrote that 2 had mild and temporary adverse events (fatigue and nausea) which were noted as being associated with the actual treatment. They did not find any serious adverse events among the subjects.

“The main limitation of this paper is that this is an interim analysis of the first 12 weeks of treatment with guselkumab; the complete analysis through Week 52 will provide a more robust dataset that will better inform the durability of the observed responses,” they wrote.

References

1. ^{Bonifati C, Lembo S, Richetta AG, Romanelli M, Satolli F, Corazza M, et al. Effectiveness of guselkumab in patients with facial and/or genital psoriasis: Interim analysis results at Week 12 from the GULLIVER study. J Eur Acad Dermatol Venereol. 2024; 00: 1–8. https://doi.org/10.1111/jdv.20187.}
2. ^{da Silva N, von Stulpnagel C, Langenbruch A, Danckworth A, Augustin M, Sommer R. Disease burden and patient needs and benefits in anogenital psoriasis: developmental specificities for person-centred healthcare of emerging adults and adults. J Eur Acad Dermatol Venereol. 2020; 34: 1010–1018.}