Guselkumab Benefits Patients With Skin of Color, Psoriasis
TOPLINE:
Guselkumab significantly improved skin clearance and quality of life in patients with moderate-to-severe psoriasis who self-identify as belonging to a racial or ethnic category other than White in a phase 3 trial.
METHODOLOGY:
Researchers conducted a phase 3b randomized study of a cohort in the VISIBLE trial, which included 103 adults with skin of color and moderate-to-severe psoriasis (mean age, 44.1 years; 28.2% women; Fitzpatrick skin types IV-VI, 68.9%) at 39 sites in the United States and Canada from August 2022 to June 2024.
More than 50% were non-White Hispanic, 23.3% were Asian, 10.7% were Black, and 7.8% were Middle Eastern individuals.
Participants were randomly assigned 3:1 to receive guselkumab or placebo with crossover to guselkumab at week 16.
Coprimary endpoints were Investigator's Global Assessment [IGA] score of 0 or 1 and Psoriasis Area and Severity Index (PASI) improvement of ≥ 90% at week 16. Secondary outcomes included complete clearance (IGA 0, PASI 100), percentage changes in PASI and body surface area, and Dermatology Life Quality Index (DLQI) scores.
TAKEAWAY:
At week 16, a significantly higher proportion of patients treated with guselkumab than those on placebo achieved IGA 0/1 (74.0% vs 0; P < .001) and PASI 90 (57.1% vs 3.8%; P < .001). No serious adverse events were reported at that time.
Complete clearance was higher in the guselkumab group: IGA 0 (32.5% vs 0%; P < .001) and PASI 100 (29.9% vs 0%; P = .002).
At week 16, guselkumab led to greater improvements in PASI (least-squares mean [LSM] change, 84.5% vs 8.3%; P < .001), body surface area (LSM change, 78.0% vs -0.4%; P < .001), and DLQI (LSM change, -12.1 vs -2.5; P < .001).
By week 48, two patients experienced serious adverse events and more than 70% of participants had IGA 0/1 and PASI 90 in both treatment groups, with nearly 50% achieving complete clearance.
IN PRACTICE:
The findings showed that 'guselkumab is highly effective for the treatment of moderate-to-severe plaque psoriasis in individuals with skin of color, inclusive of all objectively measured skin tones,' the authors wrote. The trial also demonstrated, they added, 'that achievement of diversity in randomized clinical trials is attainable, including in diseases like psoriasis, where prevalence is lower in those with skin of color.'
SOURCE:
The study was led by Andrew Alexis, MD, MPH, Department of Dermatology, Weill Cornell Medicine, New York City, and was published online on June 25 in JAMA Dermatology.
LIMITATIONS:
Use of handheld colorimeters introduced new measurement tools that lacked established reference data.
DISCLOSURES:
This study was supported by Johnson & Johnson. Alexis reported receiving personal fees and grants from multiple pharmaceutical companies, including Johnson & Johnson. Several other authors reported receiving personal fees, grants, advisory fees, research funding, and having stock options in multiple companies, including Johnson & Johnson.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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