The VISIBLE (Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety) trial has delivered groundbreaking results demonstrating the high efficacy and safety of guselkumab for moderate to severe psoriasis treatment across all skin tones. This landmark phase 3b randomized clinical trial represents the first prospective study specifically designed to evaluate psoriasis treatment in participants with skin of color across the complete spectrum of objectively measured skin tones.
Addressing Critical Research Gaps
Historically, less than 16% of participants in psoriasis clinical trials have had skin of color, contributing to significant disparities in diagnosis and treatment. People with skin of color are four times more likely to require a biopsy and wait more than three times longer for a psoriasis diagnosis compared to White individuals. The VISIBLE trial was specifically designed to address these critical gaps in dermatology research.
The study enrolled 211 participants across two cohorts: Cohort A focused on moderate to severe plaque psoriasis (103 participants), while Cohort B targeted moderate to severe scalp psoriasis (108 participants). All participants self-identified as belonging to a racial or ethnic category other than White, with representation spanning Asian (23.3% in Cohort A, 38.2% in Cohort B), Hispanic or Latino (50.5% in Cohort A, 38.2% in Cohort B), Black (10.7% in Cohort A, 10.8% in Cohort B), Middle Eastern, and multiracial populations.
Remarkable Efficacy Outcomes
Body Psoriasis Results (Cohort A)
In Cohort A, participants were randomized 3:1 to receive guselkumab 100 mg or placebo at weeks 0 and 4, then every 8 weeks. The results demonstrated superior efficacy across all primary and secondary endpoints at week 16.
For the coprimary endpoints, 74.0% of guselkumab-treated participants achieved clear or almost clear skin (IGA 0/1) compared to 0% with placebo (P < .001), while 57.1% achieved PASI 90 response versus 3.8% with placebo (P < .001). Complete skin clearance rates were equally impressive, with 32.5% achieving IGA 0 and 29.9% reaching PASI 100 with guselkumab compared to 0% for both measures with placebo.
By week 48, efficacy continued to improve with more than 70% of participants achieving both IGA 0/1 and PASI 90, and approximately 50% reaching complete clearance. Mean percentage improvements in PASI and body surface area exceeded 94% for guselkumab-randomized participants.
Scalp Psoriasis Results (Cohort B)
Cohort B demonstrated similarly impressive results for scalp psoriasis treatment. At week 16, 68.4% of guselkumab-treated participants achieved absent or very mild scalp disease (ss-IGA 0/1) compared to 11.5% with placebo (P < .001). PSSI 90 response was achieved by 65.8% versus 3.8% respectively (P < .001).
Complete scalp clearance rates were particularly striking, with 57.9% achieving ss-IGA 0 and 59.2% reaching PSSI 100 with guselkumab versus 3.8% for both measures with placebo. By week 48, approximately 70% of guselkumab-randomized participants maintained complete scalp clearance, with mean percentage improvements in PSSI and scalp surface area exceeding 94%.
Quality of Life Improvements
Both cohorts demonstrated clinically meaningful improvements in patient-reported outcomes. In Cohort A, DLQI scores improved by a mean of 12.1 points with guselkumab versus 2.5 points with placebo at week 16 (P < .001). Similarly, PSSD symptoms scores showed substantial improvements of 49.4 points versus 8.2 points respectively (P < .001).
Cohort B participants experienced comparable quality of life benefits, with DLQI improvements of 9.7 points versus 2.2 points with placebo (P < .001). Scalp itch, rated as severe at baseline (7.6 on a 10-point scale), improved to mild levels (2.5) by week 16 with guselkumab treatment.
Innovative Trial Design Promotes Diversity
The VISIBLE trial incorporated numerous innovative design features to promote diverse participation and retention. These included broadening inclusion criteria, reducing study visit frequency, providing cultural sensitivity training for investigators, and enlisting sites experienced in treating underrepresented populations.
These strategies proved highly successful, with the trial enrolling approximately seven times faster than anticipated and achieving a retention rate exceeding 90% through week 48. This demonstrates that diverse clinical trial participation is not only achievable but can be highly successful when appropriate design considerations are implemented.
Safety Profile Remains Consistent
Safety results across both cohorts were consistent with the established guselkumab safety profile from previous trials. Through week 16, infections were the most common adverse events, reported in 20.8% of guselkumab-treated participants in Cohort A and 14.8% in Cohort B. Most infections were mild to moderate, predominantly upper respiratory tract infections and nasopharyngitis.
Through week 48, pooled safety results from both cohorts (158 guselkumab-randomized participants) showed upper respiratory tract infection (12.7%), COVID-19 (5.7%), and nasopharyngitis (5.1%) as the most common adverse events. No participants experienced inflammatory bowel disease, major adverse cardiovascular events, cancer, or active tuberculosis.
Clinical Implications and Future Directions
The VISIBLE trial results provide crucial evidence that guselkumab is highly effective for treating moderate to severe psoriasis across all skin tones. The study's success in achieving diverse enrollment and high retention rates establishes a framework for future dermatology clinical trials to ensure representative participation.
During the ongoing extension phase through week 112, researchers will continue evaluating postinflammatory pigment alteration (PIPA), which disproportionately affects individuals with higher Fitzpatrick skin types. More than 20,000 clinical photographs are being collected to enhance education about recognizing and diagnosing psoriasis across different skin tones.
The VISIBLE trial represents a significant advancement in addressing healthcare disparities in dermatology, providing robust evidence for guselkumab's efficacy and safety across diverse populations while establishing new standards for inclusive clinical trial design.
