Latest news with #VISIBLEtrial
Medscape
26-06-2025
- Health
- Medscape
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.
Medscape
25-06-2025
- Health
- Medscape
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.
