Guselkumab Clears Scalp Psoriasis Across Skin Tones
TOPLINE:
In the VISIBLE trial, guselkumab led to significant and sustained improvements in scalp psoriasis severity and quality of life in patients with skin of color through 48 weeks.
METHODOLOGY:
Researchers evaluated outcomes in a cohort of patients in the phase 3b randomized VISIBLE trial, which included 102 adults with skin of color and scalp psoriasis (mean age, 42.5 years; Fitzpatrick skin type IV-VI, 62.7%; 56.9% men) at 45 sites in the US and Canada from September 2022 to June 2024.
Participants self-identified as Asian (38.2%), non-White Hispanic or Latino (38.2%), Black (10.8%), and Middle Eastern (4.9%).
Participants were randomly assigned 3:1 to receive guselkumab or placebo with crossover to guselkumab at week 16.
Coprimary endpoints were scalp-specific Investigator's Global Assessment (ss-IGA) score of 0/1 and 90% improvement in Psoriasis Scalp Severity Index (PSSI) at week 16. Secondary outcomes were changes in PSSI, scalp surface area, Dermatology Life Quality Index (DLQI), Scalp Itch Numeric Rating Scale, Psoriasis Symptoms and Signs Diary, and complete clearance.
TAKEAWAY:
At week 16, patients treated with guselkumab showed significantly higher response rates than those with placebo for ss-IGA 0/1 (68.4% vs 11.5%; P < .001) and PSSI 90 (65.8% vs 3.8%; P < .001). Complete scalp clearance was higher in the guselkumab group: ss-IGA 0 (57.9% vs 3.8%; P < .001) and PSSI 100 (59.2% vs 3.8%; P < .001).
At week 16, guselkumab led to greater mean percentage improvements in PSSI (least squares mean [LSM] change, 87.6% vs 37.8%; P < .001) and scalp surface area (SSA; LSM change, 86.6% vs 33.4%; P < .001).
Patients reported improved quality of life (DLQI: LSM change, -9.7 vs -2.2; P < .001), symptom relief (LSM change, -44.8 vs -8.3; P < .001), and improvements in itch scores (69.4% vs 24.0%; P < .001) with guselkumab vs placebo at week 16.
Over 90% of patients achieved mean percentage improvements with guselkumab in PSSI and SSA by week 48, with 67.1% achieving complete scalp clearance (ss-IGA 0). One patient in the placebo group experienced at least one serious adverse event (SAE) at week 16 vs none in the guselkumab-treated group. From 0-48 weeks, at least one SAE was reported in 2.5% of patients on guselkumab; no adverse events resulted in drug discontinuation.
IN PRACTICE:
The findings showed that 'guselkumab is highly effective for the treatment of moderate-to-severe scalp psoriasis in individuals with skin of color across the spectrum of objectively measured skin tones,' the study authors concluded.
SOURCE:
This study was led by Amy McMichael, MD, Wake Forest University School of Medicine, Winston-Salem, North Carolina, and was published online on June 25 in JAMA Dermatology.
LIMITATIONS:
Postinflammatory pigment alteration, a common concern in people with skin of color, was not fully captured.
DISCLOSURES:
Johnson & Johnson provided funding support for this study. McMichael reported receiving personal fees, nonfinancial support, and royalties from various organizations, including Johnson & Johnson. Several other authors also reported receiving personal fees, investigator fees, salary, stock, and stock options from Johnson & Johnson and multiple other companies.
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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