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. 2025 Jun 25:e251849.
doi: 10.1001/jamadermatol.2025.1849. Online ahead of print.

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

Amy McMichael  1 , Mona Shahriari  2   3 , Linda Stein Gold  4 , Theodore Alkousakis  5 , Olivia Choi  5 , Tina Bhutani  6 , Adrian O Rodriguez  7 , Stephen K Tyring  8   9 , Daphne Chan  5 , Katelyn Rowland  5 , Lorne Albrecht  10   11 , Charles Lynde  12   13 , Geeta Yadav  13   14 , Jensen Yeung  13 , Laura Park-Wyllie  15 , Tony Ma  16 , Jenny Jeyarajah  16 , Long-Long Gao  16 , Stacy Smith  17 , Angela Y Moore  18   19 , Neelam Vashi  20 , Chesahna Kindred  21   22 , Pearl Grimes  23 , Seemal R Desai  24   25 , Susan C Taylor  26 , Andrew Alexis  27 ; VISIBLE Trial Investigators
Collaborators, Affiliations

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

Amy McMichael et al. JAMA Dermatol. .

Abstract

Importance: Varying hair textures and hair care practices contribute to nuances in clinical presentation and management of scalp psoriasis across diverse patient populations. Cohort B of the VISIBLE trial enrolled participants with moderate to severe scalp psoriasis and skin of color, across the skin-tone spectrum.

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

Design, setting, and participants: This ongoing phase 3b, randomized clinical trial at 45 sites in the US and Canada enrolled adults with skin of color and moderate to severe scalp psoriasis (scalp surface area [SSA] ≥30%; Psoriasis Scalp Severity Index [PSSI] ≥12; scalp-specific Investigator's Global Assessment [ss-IGA] score ≥3; ≥1 nonscalp plaque). Data were collected from September 2022 to June 2024.

Interventions: Randomized participants (3:1) received guselkumab, 100 mg, at weeks 0, 4, and every 8 weeks, or placebo at weeks 0, 4, and 12, then guselkumab at weeks 16, 20, and every 8 weeks.

Main outcomes and measures: Coprimary end points were ss-IGA score of 0 or 1 (ss-IGA 0/1) and 90% or greater improvement in PSSI (PSSI 90) at week 16 (guselkumab vs placebo). Major secondary end points included ss-IGA 0 (complete scalp clearance), PSSI 100, percentage changes from baseline in PSSI and SSA, changes from baseline in Dermatology Life Quality Index (DLQI) and Psoriasis Symptoms and Signs Diary (PSSD) symptoms score, and 4-point or greater reduction in Scalp Itch Numeric Rating Scale (NRS) score.

Results: Of 108 participants (81 randomized to guselkumab; 27 randomized to placebo), 100 (92.6%) completed 48 weeks of treatment. The mean (SD) age overall was 42.5 (13.6) years, and 58 participants (56.9%) were male. At the week 16 primary end point, in the guselkumab (n = 76) vs placebo (n = 26) groups, respectively, response rates were as follows: ss-IGA 0/1, 68.4% (n = 52) vs 11.5% (n = 3) (P < .001); PSSI 90, 65.8% (n = 50) vs 3.8% (n = 1) (P < .001); ss-IGA 0, 57.9% (n = 44) vs 3.8% (n = 1) (P < .001); PSSI 100, 59.2% (n = 45) vs 3.8% (n = 1) (P < .001); 4-point or greater reduction in Scalp Itch NRS score (in those with a baseline score of at least 4), 69.4% (n = 50 of 72) vs 24.0% (n = 6 of 25) (P < .001). Guselkumab efficacy increased and was maintained through week 48, when guselkumab-randomized participants achieved mean (SD) percentage improvements in PSSI and SSA of 94.6% (12.2%) and 94.8% (16.2%), respectively, and 51 (67.1%) achieved ss-IGA 0. DLQI and PSSD symptoms score least-squares mean changes were -9.7 (95% CI, -11.1 to -8.2) vs -2.2 (95% CI, -4.8 to 0.4) (P < .001) and -44.8 (95% CI, -50.6 to -39.1) vs -8.3 (95% CI, -18.4 to 1.9) (P < .001), respectively, with sustained improvements through week 48. Through week 16, infections were the most common adverse events in the guselkumab (n = 12; 14.8%) and placebo (n = 1; 3.7%) groups.

Conclusions and relevance: In this randomized clinical trial, after 3 doses of guselkumab, most participants achieved significant scalp clearance and clinically meaningful quality-of-life improvements; 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 McMichael reported personal fees from Johnson & Johnson (advisory board honoraria) during the conduct of the study; and personal fees from Arcutis, Almirall, AbbVie, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, L’Oréal, LEO Pharma, Pfizer, Sanofi-Regeneron, UCB (advisory board honoraria); grants from Concert, Incyte, and Sun Pharma (research grants); nonfinancial support from Revian (advisory board); and royalties from Informa and McGraw Hill, all outside the submitted work. Dr Shahriari reported personal fees from AbbVie, Apogee, Arcutis, Bristol Myers Squibb, Dermavant, Galderma, Incyte, Johnson & Johnson, LEO, Lilly USA, Novartis, Ortho Dermatologics, Regeneron, Sanofi-Genzyme, Takeda, and UCB and served as a speaker for AbbVie, Arcutis, Bristol Myers Squibb, Dermavant, Johnson & Johnson, Lilly USA, Pfizer, Regeneron, Sanofi-Genzyme, and UCB; and served as an investigator for AbbVie, Cara, CorEvitas Atopic Dermatitis Registry, CorEvitas Psoriasis Registry, Dermavant, Dermira, Lilly USA, Mindera, Novartis, and Unio outside the submitted work. Dr Stein Gold reported personal fees from AbbVie, Amgen, Arctis, Bristol Myers Squibb, Dermavant, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, and UCB during the conduct of the study and outside the submitted work. Dr Alkousakis reported personal fees, salary, stock, and stock options from Johnson & Johnson during the conduct of the study, and stock from Eli Lilly outside the submitted work. Dr Bhutani reported personal fees for serving as the principal investigator for trials conducted by AbbVie, Castle, CorEvitas, Dermavant, Galderma, Mindera, and Pfizer, and for serving as an advisor for AbbVie, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, LEO, Pfizer, Novartis, Sun, and UCB outside the submitted work. She has received research funding from Novartis and Regeneron outside the submitted work. Dr Rodriguez reported personal fees from Johnson & Johnson during the conduct of the study and personal fees from Sun Pharma, UCB, AbbVie, LEO Pharma, Incyte, Pfizer, Arcutis, and Bristol Myers Squibb outside the submitted work. Dr Tyring reported grants from AbbVie, Agenus, AiCuris, Almirall, Amgen, Bayer, Bristol Myers Squibb, Demira, Dr Reddy's, Eli Lilly, Foamix, Galderma, Genocea, GlaxoSmithKline, Glenmark, IQVIA, Johnson & Johnson, Kiniksa, LEO, Menlo Therapeutics, Merck, Novartis, Nycomed Amersham, Parexel, Quintiles, Regeneron, Sanofi, Trevi, UCB, and Vical outside the submitted work. Dr Chan reported stock options from Johnson & Johnson outside the submitted work. Dr Rowland reported stock ownership in Johnson & Johnson. Dr Albrecht reported personal fees from Johnson & Johnson during the conduct of the study and personal fees from AbbVie, Alumis, Amgen, Arcutis, Eli Lilly, Novartis, Sun Pharma, Takeda, and UCB outside the submitted work. Dr Lynde reported speaker, consultant, and principal investigator roles for AbbVie, Amgen, Arcutis, Apogee, Bausch Health, BioJAMP, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dermavant, Eli Lilly, Endo, Fresenius Kabi, Innovaderm, Johnson & Johnson, Kyowa Kirin, LEO Pharma, Nektar, Novartis, Pfizer, Sandoz, Sun Pharma, Takeda, and UCB during the conduct of the study. 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 outside the submitted work. Dr Yeung reported personal fees from JAMP, Johnson & Johnson, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, UCB, AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galderma, and Incyte outside the submitted work. Dr Smith reported grants from Eli Lilly, Johnson & Johnson, and Sun Pharma and personal fees from Eli Lilly and AbbVie during the conduct of the study; and grants from Eli Lilly, Alumis, Amgen, Sofregen, Pfizer, Caliway, and Q32Bio outside the submitted work. Dr Moore reported grants, personal fees, and nonfinancial support from Johnson & Johnson; and grants from AbbVie, Arcutis, Acelyrin, Alumis, Amgen, Bristol Myers Squibb, Dermavant, Eli Lilly, Galderma, Incyte, Novartis, Pfizer, Sanofi, Sun Pharma, Takeda, and UCB during the conduct of the study during the conduct of the study and outside the submitted work. Dr Vashi reported personal fees from Biogen, Canfield, Johnson & Johnson, L’Oréal, Novartis, and Pfizer outside the submitted work. Dr Kindred reported personal fees from Lilly (speaker), Pfizer (speaker), AbbVie (consultant), Selphyl (medical board), Aerolase (medical board), Sun Pharma (consultant), and Regeneron (speaker) outside the submitted work. Dr Desai reported personal fees from Eli Lilly, Galderma, Incyte, Johnson & Johnson, L’Oréal, and Pfizer, and serving as the current AAD President outside the submitted work. Dr Taylor reported personal fees from Johnson & Johnson during the conduct of the study; and personal fees from AbbVie, Arcutis, Avita Medical, Beiersdorf, Biorez, 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, and Vichy Laboratoires; stock options from Armis Biopharma, GloGetter, and Piction Health; royalties from McGraw Hill; and grants from Allergan Aesthetics, Concert Pharmaceuticals/Sun Pharma, Croma Pharma GmbH, Eli Lilly, and Pfizer outside the submitted work. Dr Alexis reported personal fees from Johnson & Johnson during the conduct of the study; and grants to his institution from Leo, Amgen, Arcutis, Dermavant, AbbVie, Castle, and Incyte; advisory/consulting roles for Leo, Galderma, Pfizer, Sanofi-Regeneron, Genzyme, Dermavant, Beiersdorf, Ortho, L’Oréal, Bristol Myers Squibb, Bausch Health, UCB, Arcutis, Johnson & Johnson, Allergan, Almirall, AbbVie, Amgen, VisualDx, Eli Lilly, Swiss American, Incyte, Castle, Apogee, Canfield, Alphyn, Genentech, Boehringer Ingelheim, Symrise, and Novartis; speaker roles for Regeneron, Sanofi Genzyme, L’Oréal, Johnson & Johnson, Aerolase, and Scientis; royalties from Springer, Wiley-Blackwell, Wolters Kluwer Health, and Elsevier; and reported equipment support from Aerolase. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. VISIBLE Cohort B Study Design and Participant Disposition Through Week 48
aCoprimary end points are the proportions of participants achieving scalp-specific Investigator’s Global Assessment 0 or 1 and 90% improvement in Psoriasis Scalp Severity Index at week 16.
Figure 2.
Figure 2.. Clinical Responses in VISIBLE Cohort B Through Week 48
Proportions of participants achieving scalp-specific Investigator’s Global Assessment (ss-IGA) score of 0 or 1 (A), 90% or greater improvement in Psoriasis Scalp Severity Index (PSSI 90) (B), ss-IGA score of 0 (C), and PSSI 100 (D). The mean percentage improvement in PSSI and scalp surface area (SSA) over time is 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 < .001 for guselkumab vs placebo based on the mixed-effects model for repeated measures.
Figure 3.
Figure 3.. Patient-Reported Outcomes in VISIBLE Cohort B
Proportions of participants achieving Dermatology Life Quality Index (DLQI) of 0 or 1 (A); mean Scalp Itch numeric rating scale (NRS) score (B); and mean overall Psoriasis Symptoms and Signs Diary (PSSD) symptoms scores (C). aAmong participants with DLQI of greater than 1 at baseline. bWeek 16, nominal P = .003 for guselkumab vs placebo. cFor participants 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 analysis of covariance model. eWeek 16, P < .001 for guselkumab vs placebo based on the mixed-effects model for repeated measures. fPSSD assessments were optional at weeks 28 and 36.
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