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Clinical Trial
. 2025 Sep 1;161(9):901-911.
doi: 10.1001/jamadermatol.2025.1836.

Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial

Andrew Alexis  1 , Amy McMichael  2 , Jennifer Soung  3 , Olivia Choi  4 , Theodore Alkousakis  4 , Javier Alonso-Llamazares  5 , Mona Shahriari  6   7 , Adrian O Rodriguez  8 , Tina Bhutani  9 , Daphne Chan  4 , Katelyn Rowland  4 , Maxwell Sauder  10   11 , H Chih-Ho Hong  12   13   14 , Geeta Yadav  11   15 , Jensen Yeung  11 , Jenny Jeyarajah  16 , Tony Ma  16 , Long-Long Gao  16 , Laura Park-Wyllie  17 , Lawrence Green  18   19 , Mark Lee  20 , Neelam Vashi  21 , Chesahna Kindred  22   23 , Pearl Grimes  24 , Susan C Taylor  25 , Seemal R Desai  26   27 ; VISIBLE Trial Investigators
Affiliations
Clinical Trial

Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones: Cohort A of the VISIBLE Randomized Clinical Trial

Andrew Alexis et al. JAMA Dermatol. .

Abstract

Importance: Data and educational gaps in populations with skin of color contribute to racial and ethnic disparities in psoriasis treatment. Cohort A of the VISIBLE study includes participants with psoriasis who self-identify as belonging to a racial or ethnic category other than White, across the entire skin-tone spectrum.

Objective: To evaluate efficacy, quality of life, and adverse event outcomes among participants with moderate to severe psoriasis and skin of color who received guselkumab, 100 mg, for up to 48 weeks.

Design, setting, and participants: This ongoing phase 3b, randomized clinical trial at 39 sites in the US and Canada enrolled adults with skin of color and moderate to severe psoriasis (body surface area [BSA] ≥10%; Psoriasis Area and Severity Index [PASI] ≥12; Investigator's Global Assessment [IGA] ≥3). Data were collected from August 2022 to June 2024.

Interventions: Randomized participants (3:1) received guselkumab, 100 mg, at weeks 0 and 4, then every 8 weeks, or placebo with crossover to guselkumab at weeks 16 and 20, then every 8 weeks.

Main outcomes and measures: Coprimary end points were IGA score of 0 or 1 (IGA 0/1) and PASI improvement of 90% or more (PASI 90) at week 16 (guselkumab vs placebo). Major secondary end points included IGA 0; PASI 100; percentage changes from baseline in PASI and BSA; changes from baseline in Dermatology Life Quality Index (DLQI) and Psoriasis Symptoms and Signs Diary (PSSD) symptoms; and at least a 4-point reduction in PSSD itch.

Results: Of 103 participants (77 randomized to guselkumab; 26 randomized to placebo), 94 (91.3%) completed 48 weeks of treatment. The mean (SD) age overall was 44.1 (12.9) years, and 74 participants (71.8%) were male. At week 16, coprimary end points were achieved by greater proportions of guselkumab- vs placebo-treated participants (IGA 0/1: 57 of 77 [74.0%] vs 0 of 26; P < .001; PASI 90: 44 of 77 [57.1%] vs 1 of 26 [3.8%]; P < .001); 25 of 77 (32.5%) vs 0 of 26 achieved IGA 0 (P < .001), and 23 of 77 (29.9%) vs 0 of 26 achieved PASI 100 (P = .002). DLQI and PSSD symptoms score least-squares mean changes from baseline were -12.1 (95% CI, -13.1 to -10.9) vs -2.5 (95% CI, -4.4 to -0.6) (P < .001), and -49.4 (95% CI, -54.0 to -44.9) vs -8.2 (95% CI, -15.8 to -0.6) (P < .001), respectively. A 4-point or greater reduction in PSSD itch score was achieved by 48 (66.7%) vs 4 (16.7%) participants with a baseline score of at least 4 (P < .001). Efficacy increased and was maintained through week 48, with guselkumab-randomized participants achieving mean percentage improvements in PASI and BSA of more than 94%, and more than 50% of participants achieving complete clearance. Infections were the most common adverse events in the guselkumab (16 [20.8%]) and placebo (3 [11.5%]) groups through week 16, predominantly upper respiratory tract infection and nasopharyngitis.

Conclusions and relevance: In this randomized clinical trial, after 3 doses of guselkumab, significant skin clearance and quality of life improvements were observed in this cohort of participants with moderate to severe psoriasis and skin of color across the range of objectively measured skin tones. Improvements increased and were maintained through week 48.

Trial registration: ClinicalTrials.gov Identifier: NCT05272150.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Alexis reported personal fees from Johnson and Johnson and Canfield during the conduct of the study; grants from AbbVie, personal fees from AbbVie, Ortho, Amgen, Leo, Dermavant, Arcutis, Bristol Myers Squibb, Eli Lilly, Boehringer Ingelheim, and Novartis outside the submitted work. Dr McMichael reported personal fees from Johnson & Johnson, and AbbVie during the conduct of the study; personal fees from Sanofi Regeneron, grants from Concert and Incyte, and personal fees from Leo, Bristol Myers Squibb, UCB, Pfizer, Sun Pharma, Eli Lilly, L’Oréal, and nonfinancial support from Galderma outside the submitted work. Dr Soung reported nonfinancial support from Arcutis during the conduct of the study; personal fees and/or grants from Amgen, Arcutis, Eli Lilly, AbbVie, Pfizer, LEO Pharma, Regeneron, Sanofi, Dermavant, Novartis, Bristol Myers Squibb, Johnson & Johnson, UCB, Kobio Labs, Coval Biopharma, Boehringer Ingelheim, and Ortho Dermatologics outside the submitted work. Dr Alkousakis reported personal fees, stock, and options from Johnson & Johnson during the conduct of the study and owns stock in Eli Lilly outside the submitted work. Dr Alonso-Llamazares reported acting as principal investigator for a clinical trial with Driven Research during the conduct of the study; has served as an investigator and/or participated in advisory boards for AbbVie, Amgen, Arcutis, Bristol Myers Squibb, Cara, Dermobiont, Eli Lilly, Incyte, Johnson & Johnson, LEO, Novartis, Ortho Dermatologics, Sanofi, and Takeda, and is currently a speaker for Arcutis, Galderma, Incyte, and UCB outside the submitted work. Dr Shahriari has served as a consultant/received honoraria from AbbVie, Amgen, Apogee, Arcutis, Bristol Myers Squibb, Dermavant, Galderma, Incyte, Johnson & Johnson, LEO, Lilly USA, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, and UCB; served as a speaker for AbbVie, Arcutis, Bristol Myers Squibb, Dermavant, Galderma, Johnson & Johnson, Lilly USA, Pfizer, Regeneron, Sanofi, and UCB; and served as an investigator for AbbVie, Cara, CorEvitas Psoriasis and Atopic Dermatitis Registries, Dermavant, Dermira, Mindera, Novartis, and Union outside the submitted work. Dr Rodriguez reported personal fees from Johnson & Johnson during the conduct of the study, and from Sun Pharma, UCB, AbbVie, Leo Pharma, Incyte, Pfizer, Eli Lilly, and Arcutis outside the submitted work. Dr Bhutani is currently a principal investigator for studies being sponsored by AbbVie, Castle, CorEvitas, Dermavant, Galderma, Mindera, and Pfizer. She has additional research funding from Novartis and Regeneron. She has served as an advisor for AbbVie, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, LEO, Pfizer, Novartis, Sun, and UCB. Dr Chan reported stock ownership in Johnson & Johnson outside the submitted work. Dr Rowland reported being a shareholder of Johnson & Johnson. Dr Sauder reported personal fees from AbbVie, Amgen, Arcutis, Bausch Health, Bristol Myers Squibb, Eli Lilly Canada, Incyte, LEO Pharmaceuticals, Novartis, Sun Pharmaceuticals, UCB Canada; and served as an investigator for Alumis and Takeda outside the submitted work; and as a medical advisor for the Canadian Association of Psoriasis Patients. Dr Hong reported personal fees from AbbVie, Johnson & Johnson, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Incyte, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, and UCB outside the submitted work. Dr Yadav reported personal fees from AbbVie, Amgen, Aralez, Arcutis, Bausch Health, BioJAMP, Bristol Myers Squibb, Byrdie, Cipher, Galderma, Incyte, Johnson & Johnson, Kenvue, Leo, L’Oréal, Novartis, Paladin, Pfizer, P&G, Sanofi, Sun Pharma, UCB, and Unilever for speaking, advisory boards, honoraria, and/or clinical trials outside the submitted work. Dr Yeung reported personal fees from Johnson and Johnson, AbbVie, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galderma, Incyte, JAMP, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, and UCB outside the submitted work. Dr Green reported grants from Johnson & Johnson during the conduct of the study and personal fees from Amgen, Arcutis, Dermavant, Bristol Myers Squibb, Takeda, Galderma, OrthoDerm, UCB, Lilly, Pfizer, and Vyne outside the submitted work. Dr Lee reported grants from Johnson & Johnson during the study and from Aclaris, Boehringer Ingelheim, Pfizer, Incyte, Alumis, Apogee, Eli Lilly, Leo, AbbVie, Sanofi, and Takeda outside the study. Dr Vashi reported personal fees from Johnson & Johnson outside the submitted work. Dr Kindred reported personal fees from Lilly, Pfizer, AbbVie, Selphyl, Aerolase, Sun Pharma, and Regeneron outside the submitted work. Dr Taylor reported personal fees from Johnson & Johnson during the conduct of the study; and personal fees from AbbVie, Arcutis Biotherapeutics, Avita Medical, Beiersdorf, Biorez Inc., Bristol Myers Squibb, Cara Therapeutics, Catalyst Medical Education, CME Outfitters, Dermsquared, Dior, Eli Lilly, EPI Health, Estee Lauder, Evolus, Galderma, HMP Global, Hugel America, Incyte, LearnSkin, L’Oréal USA, Medscape, MJH Lifesciences, Pfizer, Sanofi, Scientis US, UCB, Vichy Laboratoires, and McGraw Hill; stock options in Armis Biopharma, GloGetter, and Piction Health; and grants from Allergan Aesthetics, Concert Pharmaceuticals/Sun Pharma, Croma Pharma GmbH, Eli Lilly, and Pfizer outside the submitted work. Dr Desai reported being the current AAD President and serving as a consultant/investigator for Eli Lilly, Galderma, Incyte, Johnson & Johnson, L’Oréal, and Pfizer outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. VISIBLE Cohort A Study Design and Participant Disposition Through Week 48
aCoprimary end points are the proportions of participants achieving an Investigator’s Global Assessment score of 0 or 1 and 90% improvement in Psoriasis Area and Severity Index at week 16.
Figure 2.
Figure 2.. Clinical Responses in VISIBLE Cohort A Through Week 48
Proportions of participants achieving an Investigator’s Global Assessment (IGA) score of 0 or 1 (A), Psoriasis Area and Severity Index (PASI) improvement of at least 90% (PASI 90) (B), IGA score of 0 (C), and PASI 100 (D). The mean percentage improvement in PASI and body surface area (BSA) over time are also presented (E and F). aWeek 16, P < .001 for guselkumab vs placebo. bFor participants who were randomized to placebo at week 0, only those who crossed over to guselkumab at or after week 16 were included in analyses after week 16. cWeek 16, P = .002 for guselkumab vs placebo. dWeek 16, P < .001 for guselkumab vs placebo based on the mixed model for repeated measures.
Figure 3.
Figure 3.. Key Patient-Reported Outcome End Points for VISIBLE Cohort A from Baseline to Week 48
Proportions of participants achieving Dermatology Life Quality Index (DLQI) of 0 or 1 (A); mean Psoriasis Symptoms and Signs Diary (PSSD) itch symptom scores (B); mean overall PSSD symptoms scores (C); and mean Skin Discoloration Impact Evaluation Questionnaire (SDIEQ) scores (D). aAmong participants with DLQI of more than 1 at baseline. bWeek 16, nominal P < .001 for guselkumab vs placebo. cFor participants who were randomized to placebo at week 0, only those who crossed over to guselkumab at or after week 16 were included in analyses after week 16. dWeek 16, P < .001 for guselkumab vs placebo based on the mixed model for repeated measures. ePSSD assessments were optional at weeks 28 and 36. fWeek 16, P < .001 for guselkumab vs placebo based on the analysis of covariance model.
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References

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