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Guselkumab effectively cleared the skin of patients with moderate-to-severe plaque psoriasis across all skin tones, with significant improvements observed within the first 16 weeks of treatment.
Data presented at the 2023 Fall Clinical Dermatology Conference revealed patients across all skin tones with moderate to severe plaque psoriasis treated with guselkumab achieved significantly clearer skin according to several measures of disease activity.1
A group of investigators led by Andrew F Alexis, MD, MPH, vice-chair for Diversity and Inclusion for the Department of Dermatology and Professor of Clinical Dermatology at Weill Cornell Medical College, New York City, assessed the efficacy of guselkumab compared with placebo in this patient population. In the first section of the large-scale, prospective, phase 3b, double-blind, placebo-controlled study, 103 patients were randomized 3:1 to receive either guselkumab (n = 77) or placebo (n = 26) at weeks 0, 4, 12, and 16. As it is an ongoing study the data presented at the conference included only results from the first 16 weeks (Cohort A).
Efficacy was assessed using the Psoriasis Area and Severity Index (PASI) and Investigator Global Assessment (IGA), health-related quality of life was measured by the Psoriasis Symptom and Sign Diary (PSSD), and safety information was obtained for all participants. Eligible patients self-identified as non-White, without exclusions based on Fitzpatrick Skin Types.
The baseline demographics, disease characteristics, and previous treatments were reflective of patients across all skin tones. The mean age of participants was 44.1 years, 71.8% (n = 74) were male, and the mean disease duration was 14.9 years.
At week 16, a significantly greater proportion of patients receiving guselkumab achieved IGA 0/1 (clear or almost clear) when compared with the placebo cohort (74.0% vs 0.0%, respectively). Additionally, 57.1% of patients achieved a ≥90% reduction in PASI scores (PASI 90), compared with only 3.8% of patients receiving the placebo. The median time to PASI 90 response was 13.2 weeks for the guselkumab cohort, while patients in the placebo group did not obtain this endpoint.
Additionally, approximately one-third of patients treated with guselkumab were able to achieve complete skin clearance in terms of IGA 0 and PASI 100 (32.5% and 29.9%, respectively). None of the subjects receiving the placebo were able to achieve these responses.
Approximately 75% patients in the guselkumab cohort were able to achieve a minimum of PASI 75 and investigators observed 84.5% improvement in baseline PASI compared with placebo (8.3%). Similar results were reported in percent improvement from baseline in body surface area (BSA) at week 16 in the guselkumab-treated patients compared with placebo (77.8 vs 0.0%, respectively).
Another major secondary endpoint, change from baseline in PSSD symptom score, was significantly greater in the treatment cohort compared with placebo. At week 16, change from baseline in the mean PSSD itch score was -4.7 for the guselkumab cohort and .07 for the placebo cohort.
Regarding the drug’s safety profile, a total of 29 (37.7%) patients in the guselkumab and 5 (19.2%) reported an adverse event during the 16-week study period. However, no serious adverse events were reported and only 1 subject discontinued treatment due to an adverse event. In both cohorts, the most common adverse events were infections, although no serious infections were observed. Safety information was consistent with previous research and no new safety signals were identified.
“VISIBLE results, both at week 16 and future long-term data, will enable evidence-based medical decision-making and address additional unmet needs for people across all skin tones,” investigators concluded.