Guselkumab may improve skin clearance and symptoms compared with placebo in patients with darker skin tones who had moderate to severe plaque psoriasis, according to a randomized clinical trial.
In the phase IIIb VISIBLE Cohort A trial, researchers enrolled 103 patients across the United States and Canada with moderate to severe plaque psoriasis who self-identified as non-White. The researchers randomly assigned the patients 3:1 to receive guselkumab 100 mg or placebo, with crossover to guselkumab at week 16 in those who initially received placebo. Skin tone was assessed using colorimetry across the Fitzpatrick scale. The co-primary endpoints were the proportion of patients achieving clear or almost clear skin on the Investigator’s Global Assessment (IGA) with scores of 0 to 1 and at least 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 16. Key secondary outcomes included complete clearance (IGA of 0 and PASI 100), changes in body surface area, and patient-reported measures such as the Dermatology Life Quality Index (DLQI) and a 4-point reduction in the Psoriasis Symptoms and Signs Diary (PSSD).
At week 16, 74% of the patients receiving guselkumab achieved an IGA of 0 to 1 compared with 0% receiving placebo, and about 57% of them achieved PASI 90 compared with 4% in the placebo group. Complete clearance was observed in 33% of guselkumab-treated patients vs 0% of those receiving placebo. Reductions in disease severity and affected body surface area were greater with guselkumab.
Responses increased and were maintained through week 48. More than 70% of the patients achieved IGA 0 to 1 and PASI 90, and approximately 50% achieved complete skin clearance. Mean improvements in disease severity exceeded 94%. Patient-reported outcomes improved in parallel, including reductions in DLQI scores and itch scores.
Adverse events were reported in about 38% of the patients receiving guselkumab vs 19% of those receiving placebo through week 16. The most common events were infections, including upper respiratory tract infections and nasopharyngitis. Serious adverse events were uncommon, and no new safety signals were identified through 48 weeks.
The researchers enrolled patients across racial and ethnic groups, with most having Fitzpatrick skin types IV to VI. Treatment responses were observed across this range, although the trial wasn't powered for subgroup comparisons. The crossover design limited long-term comparisons with placebo, and the sample size was modest. Use of colorimetry to classify skin tone may have also affected comparisons with prior studies.
Overall, guselkumab was associated with sustained improvements in skin clearance and quality of life in this patient population.
“Guselkumab is a highly effective, durable psoriasis treatment for people across all skin tones,” wrote lead study author Andrew Alexis, MD, MPH, of the Department of Dermatology at Weill Cornell Medicine, and colleagues.
The study was funded by Johnson & Johnson. Full disclosures of the study authors can be found in the study.
Source: JAMA Dermatology