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. 2026 Mar 2;16(4):2031–2045. doi: 10.1007/s13555-026-01688-z

The Impact of Post-inflammatory Pigment Alteration After Psoriasis: Novel Data from the VISIBLE Study

Andrew Alexis 1,✉, Amy McMichael 2, Neelam Vashi 3, Tina Bhutani 4, Jensen Yeung 5,6, Theodore Alkousakis 7, Katelyn Rowland 7, Olivia Choi 7,17, Tony Ma 7, Daphne Chan 7, Jenna Lester 8, Adrian O Rodriguez 9, Geeta Yadav 5,10, Chesahna Kindred 11,12, Pearl Grimes 13, Susan C Taylor 14, Seemal R Desai 15,16
PMCID: PMC13047027  PMID: 41770445

Abstract

Introduction

Post-inflammatory pigment alteration (PIPA) in skin previously affected by psoriasis is an important, often neglected problem. PIPA has a disproportionate negative impact in people with skin of color. The phase 3b VISIBLE study evaluated guselkumab efficacy and safety in participants with skin of color and moderate-to-severe plaque psoriasis (cohort A) or moderate-to-severe scalp psoriasis (cohort B). Here we report results from exploratory assessments of the quality-of-life impact of pigmentation changes as psoriasis lesions resolve and long-term skin clearance is achieved and of correlations between dyspigmentation and clinical and patient-reported outcomes.

Methods

Randomized (3:1) participants received guselkumab 100 mg or placebo with crossover to guselkumab at week 16. Patient-reported impact of dyspigmentation on quality of life was assessed via Skin Discoloration Impact Evaluation Questionnaire (SDIEQ). Correlations between SDIEQ, Psoriasis Area and Severity Index (PASI), and Dermatology Life Quality Index (DLQI) were assessed. Pigmentation journeys were tracked using standard and cross-polarized photographs evaluated for erythema, pigmentation, and skin tone evenness.

Results

Across treatment and Fitzpatrick skin type groups (N = 205), mean SDIEQ scores decreased from 8.4–9.5 (moderate impact) at baseline to 1.3–1.9 (mild impact) at week 48. Photographic improvements in pigmentation were also observed. The majority of guselkumab-treated participants achieved clear or almost clear skin at week 48. In cohort A, mean percent PASI improvement from baseline was 94.9%; in cohort B mean percent Psoriasis Scalp Severity Index improvement was 94.6%. At week 48, correlation between SDIEQ and DLQI (r = 0.7456; p < 0.001) was stronger than between PASI and DLQI (r = 0.3345; p < 0.001).

Conclusion

Following treatment with guselkumab, most participants achieved clear or almost clear skin and substantial improvements in skin discoloration. Exploratory analyses showed SDIEQ improvements impacted quality of life more than PASI improvements, suggesting greater attention to PIPA is warranted in comprehensive psoriasis management, especially for patients with skin of color.

ClinicalTrials.gov Identifier

NCT05272150.

Keywords: Dyspigmentation, Guselkumab, Hyperpigmentation, Hypopigmentation, Inflammation, Pigmentation, Psoriasis, Quality of life, Skin of color

Plain Language Summary

There are many effective treatments for psoriasis that can help patients achieve clear or almost clear skin. However, as psoriasis clears, skin that was affected by lesions can look darker or lighter than the surrounding skin. It can take months or years for pigmentation to return to normal after psoriasis resolves. These lasting pigmentation changes are more common and more severe in people with skin of color and can have a large negative effect on quality of life. The VISIBLE study evaluated the efficacy and safety of a biologic medicine called guselkumab for the treatment of moderate-to-severe psoriasis in people with skin of color. Most participants treated with guselkumab had clear or almost clear skin after 16 weeks of treatment. However, photographs of affected skin show that many people had pigmentation changes (areas of darker or lighter skin) where the psoriasis lesions had cleared after starting treatment. VISIBLE also included surveys asking participants how much pigmentation changes affected their quality of life, including whether skin discoloration made them feel self-conscious or unattractive, and whether it caused them to hide their skin from others or affected their interpersonal, social, and leisure activities. Results showed that improvements in pigmentation impacted participants’ quality of life more than improvements in overall psoriasis disease severity. These results, showing that skin discoloration can have large effects on patients’ quality of life, suggest that healthcare providers should include assessments of pigmentation changes as part of comprehensive psoriasis disease management.

Key Summary Points

Why carry out this study?
Post-inflammatory pigment alteration (PIPA) is a significant but often overlooked aspect of psoriasis disease burden that can have profound negative effects on quality of life and mental health, especially in individuals with skin of color.
VISIBLE is the first randomized controlled trial to include assessments of pigmentation journeys from baseline through resolution of psoriasis plaques and beyond.
What was learned from the study?
Results of this exploratory analysis show that PIPA is more strongly correlated with quality-of-life outcomes than overall skin clearance.
It is important for patients to be counselled about PIPA at the start of their psoriasis treatment journey and provided with guidance about possible changes in pigmentation during treatment.
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Introduction

Psoriasis is a chronic inflammatory skin condition that affects approximately 3% of the US population [1, 2]. Psoriasis prevalence has been reported to be lower in non-white populations [1, 2]; however, prevalence is likely underestimated in those with skin of color because of factors including underdiagnosis, selection bias, and reduced access to care [3, 4]. Furthermore, studies have shown that patients with skin of color tend to have more severe psoriasis than white patients [3–5].

Psoriasis plaques are often painful and pruritic, and lesions affecting highly visible areas are associated with stigma and psychosocial burdens, all of which can have profound negative effects on quality of life [6–9]. The clinical presentation of psoriasis varies considerably based on skin tone. In patients with lighter skin tones, affected areas are typically red or pink, whereas in patients with darker skin tones, plaques can appear violaceous, dark brown, or gray, with less discernible inflammation and more post-inflammatory pigment alteration (PIPA) in skin previously affected by psoriasis [10–12].

Data are limited on the prevalence of PIPA in patients with psoriasis, in part because traditional psoriasis assessments, including the Psoriasis Area and Severity Index (PASI) and Investigator’s Global Assessment (IGA), do not capture dyspigmentation as a measure of disease severity. One study estimated that approximately 24% of patients with psoriasis experience PIPA, including both hyperpigmentation (14%) and hypopigmentation (10%) [13]. However, PIPA prevalence has likely been vastly underestimated, since recent surveys report that more than 80% of patients with psoriasis consider PIPA to be an important, neglected problem, and 73% report unmet need in the treatment of PIPA [14]. The disproportionate impact of PIPA, both in prevalence and severity [15], among people with skin of color contributes to greater negative psychological impact of psoriasis in this population, in some cases causing a burden similar in severity to the underlying psoriasis [10, 16, 17].

VISIBLE (Varying Skin Tones in Body and Scalp Psoriasis: Guselkumab Efficacy and Safety; ClinicalTrials.gov Identifier NCT05272150) is a first-of-its kind, phase 3b, randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of guselkumab for moderate-to-severe plaque psoriasis in participants with skin of color [18]. VISIBLE includes participants with objectively measured skin tones, across the entire spectrum, ranging from Fitzpatrick skin type (FST) I to VI [19, 20]. VISIBLE was uniquely designed to collect data on PIPA throughout the study. Here we present VISIBLE results of exploratory analyses evaluating the impact of PIPA on quality of life, correlations between dyspigmentation and other clinical and patient-reported outcomes, and pigmentation changes through 1 year in participants treated with guselkumab.

Methods

Ethics

The VISIBLE study protocol was approved by appropriate institutional review boards (IRBs) or independent ethics committees. The central IRB is Advarra (Columbia, Maryland, USA; registration number 00000971). Prior to any study-related activity, participants provided informed consent in accordance with the principles of the Declaration of Helsinki, Good Clinical Practice and International Council on Harmonisation guidelines, applicable regulatory requirements, and sponsor policy.

Participants

VISIBLE enrolled participants with moderate-to-severe plaque psoriasis (cohort A) [21] or moderate-to-severe scalp psoriasis (cohort B) [22]. Full study inclusion and exclusion criteria and study design details have been previously reported [18]. Briefly, in both cohorts, eligible participants self-identified their race/ethnicity as non-white, and had a diagnosis of plaque psoriasis for ≥ 6 months before the first administration of study agent, an expert-panel-confirmed diagnosis based on clinical photographs, or biopsy-confirmed psoriasis, and were candidates for phototherapy or systemic treatment for psoriasis. Participants in cohort A were required to have psoriasis body surface area (BSA) ≥ 10%, PASI ≥ 12, and IGA ≥ 3 [21]. Participants in cohort B were required to have psoriasis scalp surface area (SSA) ≥ 30%, Psoriasis Scalp Severity Index (PSSI) ≥ 12, and scalp-specific IGA ≥ 3 [22].

Study Design

Participants were randomized 3:1 to receive subcutaneous injections of guselkumab 100 mg or placebo at weeks 0, 4, and 12. Participants in the guselkumab group continued to receive maintenance dosing every 8 weeks. At week 16, participants in the placebo group crossed over to receive guselkumab at week 16, week 20, then every 8 weeks. Blinded treatment continued through week 48, after which, participants entered a long-term extension with treatment through week 100 and a final safety visit at week 112 [18].

Assessments

At screening, each participant’s skin tone was determined using colorimetry and fitted to the FST I–VI scale, consistent with data from previous studies [23, 24]. Skin tone was determined at a non-sun-exposed area (e.g., upper medial arm) based on individual typology angle and melanin index [23, 24].

Assessments used to evaluate the impact of PIPA and skin clearance on quality of life include the Skin Discoloration Impact Evaluation Questionnaire (SDIEQ), PASI, PSSI (cohort B only), Dermatology Life Quality Index (DLQI), and Patient-Reported Outcomes Measurement Information System (PROMIS®-29) Profile depression and anxiety domain scores. The SDIEQ is a patient-reported outcome measure (PROM) with five questions assessing the impact of skin discoloration over the last week on self-consciousness, perceived distractions and unattractiveness related to skin discoloration, effort put into hiding skin discoloration from others, and effects of skin discoloration on social and leisure activities, with response options ranging from “not at all” to “very much”. Total SDIEQ scores range from 0 to 15, with 0–6 = mild effect, 7–11 = moderate effect, and 12–15 = severe effect [25, 26]. The PASI is a clinician-reported measure of psoriasis surface area and erythema, induration, and scaling at four body regions (head, trunk, upper and lower extremities), with total scores ranging from 0 to 72 [27]. The clinician-reported PSSI measures extent of scalp psoriasis involvement and severity of lesional erythema, induration, and desquamation (range 0–72) [28, 29]. The DLQI is a 10-question PROM that assesses the effect of skin problems on symptoms and feelings, daily activities, leisure, work/school, personal relationships, and treatment, with scores ranging from 0 to 30 [30]. Depression and anxiety are two of seven domains assessed by the PROMIS-29 Profile, which is a set of self-reported measures used to evaluate health in general populations and in individuals with chronic conditions. Respondents report the frequency of depression and anxiety symptoms over the past 7 days from 1 (never) to 5 (always). Raw scores are converted into standardized T-scores, with a mean score of 50 representing the average for the general US population. Depression scores range from 41.0 to 79.4, and anxiety scores range from 40.3 to 81.6 [31–33].

Standard and cross-polarized photographs were used to evaluate skin clearance and pigmentation changes over time. Photographic services were managed through a central laboratory (Canfield Scientific, Parsippany, NJ) that used a detailed instruction manual to ensure image quality and consistency.

Statistical Analyses

For these analyses, data were pooled from VISIBLE cohort A and cohort B. The full analysis population included all randomized participants. The efficacy analysis population included all participants who were correctly randomized (six participants in cohort B should have been included in cohort A and were therefore excluded from efficacy analyses). Mean changes from baseline in PASI and PSSI were calculated for participants in cohort A and B, respectively, from week 0 to week 48 to summarize the level of skin clearance achieved during blinded treatment. At week 48, Pearson correlation coefficients were calculated for comparisons between both SDIEQ and PASI versus DLQI, PROMIS-29 depression, and PROMIS-29 anxiety scores for all participants and by FST group (I–III and IV–VI).

In an exploratory pilot analysis to qualitatively assess participant post-inflammatory pigmentation changes over time, all photographs collected during the study were reviewed, and PIPA was classified by clinicians as none/minimal, hypopigmentation, hyperpigmentation, or mixed pigmentation changes using a sampling of standard photographs. Additional exploratory analyses of cross-polarized photographs were performed using RBX® Technology (Canfield Medical Imaging, Fairfield, NJ) to evaluate erythema and pigmentation over time using red and brown processing, respectively [34]. Skin color evenness was objectively assessed using an algorithm that measures overall variation in color values across a defined area and how rapidly those colors change spatially within that area. Scores range from 0 (e.g., black and white alternating pixels) to 1.0 indicating completely even skin tone. Images with few distinguishable colors (determined from the a* and b* color channels of the L*a*b* color space) [23, 35] and very gradual changes in color achieve a high color evenness score (i.e., close to 1.0).

Results

Participants

The VISIBLE study population included participants with objectively measured skin tones representative of the full range of FST categories (Fig. 1); 65.9% of participants had FST in the IV–VI range. Detailed baseline demographic and disease characteristics have been previously reported [18, 21, 22]. Notably, participants in the full analysis population (N = 211) had high rates of comorbidities, including dyslipidemia (71.6%), hypertension (63.0%), metabolic syndrome (32.2%), and diabetes mellitus (21.8%). At baseline, participants in both cohorts had extensive skin and/or scalp disease, 29.8% had psoriatic arthritis, and mean DLQI scores indicating psoriasis had a very large effect on quality of life [36]. In cohort A (N = 103), mean (standard deviation [SD]) PASI was 20.8 (9.1), mean (SD) BSA involvement was 26.8% (19.3), and mean (SD) DLQI was 15.3 (7.8). In cohort B (N = 102), mean (SD) PSSI was 34.3 (13.2), mean (SD) SSA involvement was 59.8% (26.0), and mean (SD) DLQI was 14.2 (7.6). At baseline, participants from both VISIBLE cohorts reported substantial impact of skin discoloration due to psoriasis on quality of life, with mean SDIEQ scores ranging from 8.4 to 9.5 (Fig. 2), regardless of skin tone.

Fig. 1.

Fig. 1

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Self-identified racial and ethnic backgrounds and colorimeter-determined Fitzpatrick skin type (I–VI) in the VISIBLE cohort A + cohort B full analysis population (N = 211). Figure reproduced from: Alexis A, et al. JAMA Dermatol. 2025;161(3)256–264. ©2025 by the authors; originally published by the JAMA Network under a Creative Commons Attribution-Non-Commercial-No Derivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Fig. 2.

Fig. 2

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Improvements in mean SDIEQ scores by FST group from baseline to week 48 in the pooled VISIBLE cohort A + cohort B efficacy analysis population (N = 205). For participants who were randomized to PBO at baseline, only those who crossed over to GUS at or after week 16 were included in analyses at weeks 24 and 48. If participants discontinued study agent due to lack of efficacy, worsening of psoriasis, or use of a prohibited psoriasis treatment, baseline values were assigned from that point forward (non-responder imputation). FST, Fitzpatrick skin type; GUS, guselkumab; PBO, placebo; SDIEQ, Skin Discoloration Impact Evaluation Questionnaire

Skin Clearance and Patient-Reported Impact of Skin Discoloration

The majority of guselkumab-treated participants achieved complete or almost complete skin clearance at week 48. In cohort A, mean percent PASI improvement from baseline was 94.9%, and in cohort B mean percent PSSI improvement from baseline was 94.6%. Rapid and substantial reductions in mean SDIEQ scores were achieved by week 16 among guselkumab-randomized participants and by week 24 for participants in the placebo group who crossed over to guselkumab at week 16; improvements continued for all participants in both the FST I–III and FST IV–VI groups through week 48 (Fig. 2).

Correlations Between Outcome Measures

Table 1 shows correlation coefficients for comparisons of SDIEQ and PASI with DLQI, PROMIS-29 depression, and PROMIS-29 anxiety scores for all participants and by FST group. The correlation between the impact of skin discoloration as measured by SDIEQ and overall impact of psoriasis on quality of life as measured by DLQI was stronger than that between skin clearance as measured by PASI and DLQI for participants across all skin tones; this effect was more pronounced in participants with darker skin tones (FST IV–VI). Skin discoloration (SDIEQ) was also correlated with PROMIS-29 depression and anxiety scores, whereas no correlation was observed between PASI skin clearance and PROMIS-29 depression and anxiety scores.

Table 1.

Pearson correlation coefficients for SDIEQ and PASI with DLQI, PROMIS-29 depression, and PROMIS-29 anxiety scores at week 48 (pooled cohort A + B efficacy analysis population)

Correlation coefficients at week 48
SDIEQ PASI
DLQI
 All participants r = 0.7456 (p < 0.001) r = 0.3345 (p < 0.001)
 FST I–III r = 0.8786 (p < 0.001) r = 0.6369 (p < 0.001)
 FST IV–VI r = 0.6826 (p < 0.001) r = 0.1789 (p = 0.048)
PROMIS-29 depression
 All participants r = 0.3204 (p < 0.001) r = 0.0289 (p = 0.694)
 FST I–III r = 0.2753 (p = 0.026) r = − 0.014 (p = 0.914)
 FST IV–VI r = 0.3509 (p < 0.001) r = 0.054 (p = 0.550)
PROMIS-29 anxiety
 All participants r = 0.4116 (p < 0.001) r = 0.0525 (p = 0.474)
 FST I–III r = 0.3289 (p = 0.008) r = − 0.0413 (p = 0.744)
 FST IV–VI r = 0.4495 (p < 0.001) r = 0.0983 (p = 0.279)
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DLQI Dermatology Life Quality Index, FST Fitzpatrick skin type, PASI Psoriasis Area and Severity Index, PROMIS Patient-Reported Outcomes Measurement Information System, SDIEQ Skin Discoloration Impact Evaluation Questionnaire

Pigmentation Changes Over Time

Figure 3 shows examples of participant post-inflammatory pigmentation journeys over time, through 48 weeks of treatment with guselkumab. As psoriasis lesions cleared, post-inflammatory pigmentation changes varied from minimal to pronounced hypopigmentation and/or hyperpigmentation. Objective analysis of cross-polarized photographs showed progressively reduced erythema and greater color evenness in guselkumab-treated participants over time (example shown in Fig. 4).

Fig. 3.

Fig. 3

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Examples of participant post-inflammatory pigmentation journeys over time. These photographs were selected based on clinicians’ assessments that these are among the best examples of minimal, hypo to hyperpigmentation, mixed hyper and hypopigmentation, and hyperpigmentation, respectively, from all participant photographs collected during the VISIBLE study

Fig. 4.

Fig. 4

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Objective evaluation of cross-polarized photographs for pigmentation, color evenness, and erythema over time. Cross-polarized photographs for this participant were chosen for quantitative analysis of pigmentation, color evenness, and erythema based on consistency of room lighting, photograph angles, and participant’s consistent level of sun exposure throughout the study

Discussion

In this first-of-its-kind study that included assessments of pigmentation journeys from baseline through resolution of psoriasis plaques and beyond, VISIBLE participants reported that skin discoloration, more so than skin clearance, had a profound negative impact on quality of life. The impact of skin discoloration, measured with the SDIEQ, was correlated with PROMIS-29 depression and anxiety scores, whereas PASI was not.

The negative effects of PIPA on psychological well-being and overall health-related quality of life demonstrated in the VISIBLE study are consistent with findings from studies in patients with acne, atopic dermatitis, and other skin diseases [37]. Specifically, PIPA can have devastating psychological effects related to its impact on physical appearance, self-confidence, daily activities, and social relationships, especially in people with skin of color and when PIPA affects the face [10, 15, 17, 38–41]. Therefore, it is important for healthcare practitioners to discuss PIPA with patients when making psoriasis treatment decisions, to recognize the impact of PIPA on overall psoriasis disease burden, and to set goals for skin clearance as well as pigmentation normalization.

It is critical for patients to understand that certain topical and phototherapy treatment options could worsen dyspigmentation and that, in some cases, resolution of PIPA can take months to years and may require additional treatment [39, 42–44]. Importantly, practitioners should be sensitive to the fact that PIPA is not just a cosmetic issue for many patients and can be associated with depression, anxiety, and other psychosocial sequelae. Therefore, greater advocacy is needed to ensure patients with psoriasis have access to treatments for PIPA, similar to ongoing efforts for other pigmentary disorders with disproportionately negative effects among patients with skin of color, such as vitiligo [45, 46].

Clinical photographs from VISIBLE through 1 year of treatment highlight that pigmentation journeys can vary substantially from patient to patient (Fig. 3). While post-inflammatory pigmentation changes are known to be caused by altered synthesis and/or deposition of melanin in keratinocytes, the molecular mechanisms driving these changes are not well understood [47, 48]. Additional studies are needed to explore why some individuals develop hyperpigmentation, while others experience hypopigmentation, a mix of hyper- and hypopigmentation, or minimal pigmentation changes at the sites of resolved psoriasis lesions, and why pigmentation is labile in some patients but stable in others [13]. Future analyses of demographic and biomarker data collected in the VISIBLE study may provide insight into characteristics that can contribute to a patient’s likelihood of developing PIPA, as well as time to PIPA resolution. Factors hypothesized to be associated with PIPA include sun exposure and use of photoprotection, certain medications and cosmetic treatments, and hormone levels [44, 48].

Strengths and Limitations

To our knowledge, VISIBLE is the first multicenter, placebo-controlled psoriasis trial to include assessments of PIPA and its direct impact on patient-reported quality of life. Assessments of constitutive skin tone and pigmentation using objective measures have generated novel data on pigmentation after psoriasis treatment and clearance of lesional skin.

In some cases, analyses were limited by the quality of photographs and uniformity of conditions at each assessment time point (e.g., slight changes in photograph angles, lighting, skin tone due to sun exposure, participant hairstyles and/or clothing). Additionally, assessments of the impact of skin discoloration based on SDIEQ do not provide an estimate of total PIPA prevalence, which is a gap in the current psoriasis literature [13]. Furthermore, interpretation of SDIEQ results are limited because the instrument has not yet been fully validated for responsiveness to change or interpretability/minimal important change thresholds. However, based on the observed high mean SDIEQ scores at baseline, it is clear that most participants were very bothered by dyspigmentation at the start of the study, and over time, discoloration improved as psoriasis lesions cleared.

The pilot project to track individuals’ pigmentation journeys using standard and cross-polarized photography lays groundwork for more comprehensive assessments across the full study population. The 2-year VISIBLE study duration should allow adequate time to evaluate whether PIPA has resolved after clearance of psoriasis lesions [49].

More than 20,000 patient photographs will have been collected through the end of the study, including half-body and lesional area images. Evaluating these photographs in combination with colorimetry, SDIEQ, and Post-Inflammatory Dyspigmentation Area and Severity Index (PIDASI) [14] results may provide an estimate of the PIPA prevalence in this study population and better characterization of PIPA risk factors and phenotypes.

Gaps persist in our understanding of the molecular mechanisms driving PIPA, and more research is needed to identify predictors of PIPA onset, treatment response, and resolution in psoriasis and other inflammatory dermatologic diseases. Photographs and other data collected in the VISIBLE study (e.g., biopsy and skin scraping samples) may allow for more objective analyses of PIPA, which could enable healthcare providers to better counsel their patients on the physical and psychological aspects of pigmentation changes in psoriasis, providing a more holistic approach to dermatologic and associated mental health care.

Conclusion

PIPA is a significant but often overlooked aspect of psoriasis disease burden that can have negative effects on quality of life and mental health, especially in individuals with skin of color. Results from these exploratory analyses of data from the VISIBLE trial support that PIPA is more strongly correlated with quality-of-life outcomes than overall skin clearance in people with skin of color. Hence, it is especially important for non-white patients to be counselled at the start of their psoriasis treatment journey and provided with anticipatory guidance regarding possible changes in pigmentation during the course of their treatment.

Acknowledgements

The authors thank the VISIBLE study participants and their caregivers.

Medical Writing/Editorial Assistance

Medical writing support was provided by Cherie Koch, PhD, of Johnson & Johnson, under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med 2022;175:1298–1304).

Author Contributions

Conceptualization: Andrew Alexis, Amy McMichael, Neelam Vashi, Tina Bhutani, Jensen Yeung, Theodore Alkousakis, Katelyn Rowland, Olivia Choi, Daphne Chan, Jenna Lester, Adrian O. Rodriguez, Geeta Yadav, Chesahna Kindred, Pearl Grimes, Susan C. Taylor, Seemal R. Desai. Methodology and data collection: Andrew Alexis, Amy McMichael, Neelam Vashi, Tina Bhutani, Jensen Yeung, Theodore Alkousakis, Katelyn Rowland, Olivia Choi, Tony Ma, Daphne Chan, Jenna Lester, Adrian O. Rodriguez, Geeta Yadav, Chesahna Kindred, Pearl Grimes, Susan C. Taylor, Seemal R. Desai. Formal analysis: Theodore Alkousakis, Tony Ma. Writing—original draft preparation: Andrew Alexis, Olivia Choi, Katelyn Rowland. Writing—review and editing: Andrew Alexis, Amy McMichael, Neelam Vashi, Tina Bhutani, Jensen Yeung, Theodore Alkousakis, Katelyn Rowland, Olivia Choi, Tony Ma, Daphne Chan, Jenna Lester, Adrian O. Rodriguez, Geeta Yadav, Chesahna Kindred, Pearl Grimes, Susan C. Taylor, Seemal R. Desai. Supervision: Daphne Chan, Theodore Alkousakis. All authors read and approved the final manuscript.

Funding

This study was supported by Johnson & Johnson, Horsham, PA, USA. The journal’s Rapid Service Fee was funded by Johnson & Johnson.

Data Availability

The data sharing policy of Johnson & Johnson Innovative Medicine is available at https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access Project site at http://yoda.yale.edu.

Declarations

Conflict of Interest

Andrew Alexis has received grants (funds to institution) from AbbVie, Amgen, Arcutis, Castle, Dermavant, Genentech, Incyte, and LEO; has served on an advisory board or consulted for AbbVie, Allergan, Almirall, Alphyn, Alumis, Amgen, Apogee, Arcutis, Bausch Health, Beiersdorf, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Canfield, Castle, Dermavant, Eli Lilly, Galderma, Genentech, HairDays, Incyte, Johnson & Johnson, LEO, L’Oréal, Novartis, Ortho, Oruka, Pfizer, Sanofi-Regeneron, Swiss American, Symrise, UCB, Veradermics, and VisualDx; has served as a speaker for Aerolase, Johnson & Johnson, L’Oréal, Regeneron, Sanofi-Genzyme, and Scientis; has received royalties from Elsevier, Springer, Wiley-Blackwell, and Wolters Kluwer Health; and has received equipment from Aerolase. Amy McMichael has received grants (funds to institution) and/or served as consultant/advisor for AbbVie, Almirall, Arcutis, Bristol Myers Squibb, Eli Lilly, Galderma, Johnson & Johnson, Kenvue, L’Oréal, Nutrafol, Pfizer, Revian, Sanofi-Genzyme, and UCB. Neelam Vashi has served as a consultant for Biogen, Canfield, Johnson & Johnson, L’Oréal, Novartis, and Pfizer. Tina 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 Pharma, Pfizer, Novartis, Sun, and UCB. Jensen Yeung is a speaker/consultant/honoraria/trialist for AbbVie, Amgen, Anacor, Arcutis, Astella, Bausch, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Coherus, Dermira, Eli Lilly, Forward, Galderma, Johnson & Johnson, Leo, Medimmune, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun, Takeda, UCB, and Xenon. Katelyn Rowland, Theodore Alkousakis, and Tony Ma are employees of Johnson & Johnson and may own Johnson & Johnson stock/stock options. Olivia Choi was an employee Johnson & Johnson at the time this work was conducted and is a shareholder of Johnson & Johnson; she is currently an employee of Apogee Therapeutics. Daphne Chan was an employee Johnson & Johnson at the time this work was conducted and is a shareholder of Johnson & Johnson. Jenna Lester serves on the advisory board for Mattice Biosciences and OurX and is a consultant for L’Oréal and Google. Adrian O. Rodriguez has served as an advisor and/or speaker for Arcutis, Dermavant, Eli Lilly, EPI Health, Johnson & Johnson, Leo, Novartis, Sciton, Sun, and UCB. He owns stock in Strathspey Crown. Geeta Yadav has reported consultant/speaker/advisory board honorarium 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; and grants, research or clinical trial support from AbbVie, Amgen, Johnson & Johnson, Lilly, Moonlake, and Sanofi. Chesahna Kindred has served as a consultant, advisory board member, and/or speaker for AbbVie, Johnson & Johnson, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun, and UCB; has served as an investigator and/or medical board member for AbbVie, Aerolase, Lilly, Pfizer, and Selphyl; and is a journal editor for Cutis. Pearl Grimes has served as a clinical investigator and/or consultant for AbbVie/Allergan, Clinuvel, Galderma, Incyte, Johnson & Johnson, LaserOptek, L’Oréal, Medscape, Mother Science, Pfizer, RAPT, SkinBetterScience, and VYNE. Pearl Grimes is an Editorial Board member of Dermatology and Therapy. Pearl Grimes was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Susan C. Taylor has received honoraria/stock options serving as an advisor/consultant and/or speaker for AbbVie, Arcutis, Armis, Avita, Beiersdorf, Biorez, Bristol Myers Squibb, Cara, Dior, Eli Lilly, EPI, Evolus, Galderma, GloGetter, Hugel America, Johnson & Johnson, L’Oréal, Medscape/WebMD, MJH LifeSciences, Piction Health, Regeneron/Sanofi, Scientis US, UCB, Vichy, Mercer Strategies (honoraria/Board of Directors), McGraw-Hill (author/royalties), editorial board: Practical Dermatology, Cutis, Archives in Dermatologic Research, British Journal of Dermatology (peer reviewer); investigator: Concert Pharmaceuticals, Croma-Pharma, Eli Lilly, and Pfizer. Seemal R. Desai serves as a consultant and/or investigator for a variety of different organizations including Eli Lilly, Galderma, Incyte, Johnson & Johnson, L’Oréal, Pfizer and others. He also serves in numerous leadership capacities within Dermatology.

Ethical Approval

The VISIBLE study protocol was approved by appropriate institutional review boards (IRBs) or independent ethics committees. The central IRB is Advarra (Columbia, Maryland, USA; registration number 00000971). Prior to any study-related activity, participants provided informed consent in accordance with the principles of the Declaration of Helsinki, Good Clinical Practice and International Council on Harmonisation guidelines, applicable regulatory requirements, and sponsor policy.

Footnotes

Prior Presentation: Portions of the results of this analysis were presented at the 2024 Fall Clinical Dermatology Conference and the 21st Annual Skin of Color Society Scientific Symposium: Alexis A, McMichael A, Bhutani T, et al. Shadows of inflammation: exploring post-inflammatory pigment changes in VISIBLE, a phase 3b randomized controlled study of guselkumab for moderate-to-severe plaque psoriasis dedicated to people of color. Poster presented at Fall Clinical Dermatology Conference; October 24–27, 2024; Las Vegas, Nevada. Dawamne T, Choi O, Tran A, et al. VISIBLE post-inflammatory pigmentation journeys: exploring the impact of pigmentation. Poster presented at the 21st Annual Skin of Color Society Scientific Symposium; March 6, 2025; Orlando, Florida.

Publisher's Note

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Data Availability Statement

The data sharing policy of Johnson & Johnson Innovative Medicine is available at https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access Project site at http://yoda.yale.edu.

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