Guselkumab in Skin of Color: Results from a Randomized Phase 3b Psoriasis Trial

Clinical trials in psoriasis have historically lacked representation across the full spectrum of skin pigmentation. As a result, this underrepresentation has contributed to diagnostic delays and therapeutic gaps.

Cohort A of the VISIBLE trial directly addresses this deficit by evaluating the selective IL-23p19 monoclonal antibody, guselkumab, in a population with moderate-to-severe plaque psoriasis, where 68.9 percent had Fitzpatrick skin types (FST) IV to VI. This study represents a strategic shift in dermatologic research by explicitly enrolling participants with skin of color and objectively measuring skin tone using colorimetry.

This randomized, placebo-controlled, phase 3b clinical trial was conducted across 39 sites in the U.S. and Canada. A total of 103 participants self-identified as non-White and had moderate-to-severe psoriasis, defined by body surface area (BSA) of 10% or more, Psoriasis Area and Severity Index (PASI) of 12 or more, and Investigator’s Global Assessment (IGA) of at least 3.

Participants were randomized 3:1 to guselkumab (100 mg subcutaneously at weeks 0 and 4, then every 8 weeks) or placebo, with crossover to guselkumab at week 16 for the placebo group.

Efficacy Outcomes

At week 16, guselkumab was significantly superior to placebo in achieving both co-primary endpoints:

• 74% of treated participants reached IGA 0 or 1, compared to 0% in the placebo group (P < .001)
• 57.1% achieved PASI 90, compared to 3.8% in the placebo group (P < .001)

Complete skin clearance (PASI 100) was achieved by 29.9% of guselkumab-treated participants at week 16 versus 0% with placebo, increasing to approximately 50% by week 48.

Improvements in mean PASI and BSA exceeded 94% by week 48, indicating sustained therapeutic benefit.

Patient-Reported Outcomes

Meaningful improvements in quality of life were observed. By week 16, the guselkumab group had a mean Dermatology Life Quality Index (DLQI) reduction of −12.1 compared to −2.5 in the placebo group (P < .001), a change exceeding the minimal clinically important difference. By week 48, more than half of participants with baseline DLQI of greater than 1 had achieved DLQI 0 or 1, indicating no disease impact on daily life.

Similar magnitude improvements were seen in Psoriasis Symptoms and Signs Diary (PSSD) symptoms and itch scores, with over two thirds achieving a clinically significant four-point reduction in itch severity by week 16.

The Skin Discoloration Impact Evaluation Questionnaire (SDIEQ) was used here for the first time in a psoriasis trial. For context, it’s a five-item patient-reported tool that assesses how skin pigmentation changes affect quality of life, with scores ranging from 0 (mild impact) to 15 (severe impact). In this study, it revealed substantial gains: a mean reduction of 6.9 points in the guselkumab group by week 16, sustained through week 48, indicating improved dyspigmentation-related quality of life.

Safety and Tolerability

In terms of safety, guselkumab’s profile was consistent with earlier trials, with no new safety signals observed. Through week 48, infections, such as mild upper respiratory tract infections, were the most frequent adverse events (36.4%).

No cases of inflammatory bowel disease, major cardiovascular events, or anaphylaxis occurred. Serious infections were rare, and only two participants discontinued due to adverse events.

Trial Implementation and Broader Implications

VISIBLE incorporated deliberate strategies to improve recruitment and retention of underrepresented populations, including inclusive eligibility criteria, minimized visit burdens, and culturally responsive site training. These design elements contributed to a greater than 90 percent retention rate at 48 weeks and a recruitment pace that exceeded projections sevenfold.

By rigorously evaluating guselkumab in a demographically diverse cohort using validated clinical and patient-centered metrics, the VISIBLE trial confirms the drug’s efficacy and safety across all skin tones. These data support broader confidence in prescribing guselkumab for moderate-to-severe psoriasis in populations historically excluded from pivotal trials and provide a replicable model for inclusive trial design in dermatology and beyond.

Reference:
Alexis A, McMichael A, Soung J, et al. Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial. JAMA Dermatol. 2025;161(9):901-911. doi:10.1001/jamadermatol.2025.1836