Patient flow for the entire VOYAGE 1 and VOYAGE 2 populations have been reported previously.11,12 ADA indicates adalimumab; AE, adverse event; DC, discontinued; f-PGA, fingernail Physician’s Global Assessment; GUS, guselkumab; hf-PGA, Physician’s Global Assessment of the hands and/or feet; LOE, lack of efficacy; LTF, lost to follow-up; NC, noncompliance with treatment; PBO, placebo; PV, protocol violation; ss-IGA, scalp-specific Investigator’s Global Assessment; WD, withdrawal by patient.
aTo be eligible for these analyses, patients had to have a baseline score of 2 or higher.
A score of 0 indicated complete clearance. f-PGA indicates fingernail Physician’s Global Assessment; hf-PGA, Physician’s Global Assessment of the hands and/or feet; NAPSI, Nail Psoriasis Severity Index; ss-IGA, scalp-specific Investigator’s Global Assessment.
aP < .001 for guselkumab vs adalimumab.
eTable 1. Scalp-Specific Investigator’s Global Assessment (ss-IGA)
eTable 2. Physician’s Global Assessment of Hands and/or Feet (hf-PGA)
eTable 3. Fingernail Physician’s Global Assessment (f-PGA)
eTable 4. Target Nail Psoriasis Severity Index (NAPSI)
eTable 5. Demographic and Disease Characteristics of Randomized Patients With Scalp-Specific Investigator’s Global Assessment Scores at Baseline
eTable 6. Demographic and Disease Characteristics of Randomized Patients With Physician’s Global Assessment of the Hands and/or Feet Scores at Baseline
eTable 7. Demographic and Disease Characteristics of Randomized Patients With Fingernail Physician Global Assessment Scores at Baseline
eTable 8. Demographic and Disease Characteristics of Randomized Patients With Nail Psoriasis Severity Index Scores at Baseline
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Foley P, Gordon K, Griffiths CEM, et al. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2018;154(6):676–683. doi:10.1001/jamadermatol.2018.0793
How effective is guselkumab compared with adalimumab in treating psoriasis of the scalp, palms and/or soles, and fingernails?
In this secondary analysis of 2 randomized clinical trials including 1829 patients, higher proportions of patients randomized to guselkumab vs placebo achieved complete or near-complete clearance in regional psoriasis during the placebo-controlled period. Higher proportions of guselkumab- vs adalimumab-treated patients achieved complete or near-complete clearance of the scalp and palms and/or soles; proportions were comparable for guselkumab and adalimumab for fingernail psoriasis after 6 months of treatment.
Guselkumab is an important new treatment option for patients with psoriasis in difficult-to-treat body regions.
Psoriasis of the scalp, palms and/or soles, and nails is challenging to treat.
To evaluate the effect of guselkumab on psoriasis in specific body regions.
Design, Setting, and Participants
VOYAGE 1 and VOYAGE 2 were, double-blind, placebo- and adalimumab-controlled studies of guselkumab conducted at 101 and 115 global sites, respectively, from November 3, 2014, to May 19, 2016. Patients had moderate to severe plaque psoriasis (Psoriasis Area and Severity Index score ≥12, Investigator’s Global Assessment [IGA] score ≥3, and ≥10% body surface area with psoriasis). This post hoc data analysis was performed from February 10 through November 15, 2017.
Patients were randomized to guselkumab, 100 mg (weeks 0 and 4, then every 8 weeks); placebo followed by guselkumab, 100 mg, starting at week 16; or adalimumab (80 mg [week 0] and 40 mg [week 1, then every 2 weeks]).
Main Outcomes and Measures
Efficacy was assessed through week 24. End points included numbers of patients achieving scores of 0 or 1 (clear or near clear) or 0 (clear) on the scalp-specific IGA (ss-IGA), Physician’s Global Assessment of the hands and/or feet (hf-PGA), and fingernail PGA (f-PGA) and percentage of improvement in target Nail Psoriasis Severity Index score.
Of 1829 randomized patients (mean [SD] age, 43.6 [12.4] years; 1300 [71.1%] male, 1498 [81.9%] white), 1576 (86.2%) had psoriasis of the scalp; 501 (27.4%), palms and/or soles; and 1049 (57.4%), fingernails. At baseline, 1512 (82.7%), 461 (25.2%), and 928 (50.7%) patients had a score of 2 or higher on the ss-IGA, hf-PGA, and f-PGA, respectively, and were included in the analysis. Guselkumab was superior to placebo based on the proportion of patients achieving an ss-IGA score of 0 or 1 (560 [81.8%] vs 43 [12.4%]) at week 16 and to adalimumab (582 [85.0%] vs 329 [68.5%]) at week 24 (both P < .001); 479 (69.9%) in the guselkumab group vs 270 (56.3%) in the adalimumab group achieved an ss-IGA score of 0 (all P < .001). An hf-PGA score of 0 or 1 was achieved by 154 patients (75.5%) in the guselkumab group vs 15 (14.2%) in the placebo group at week 16 and 164 (80.4%) in the guselkumab group vs 91 (60.3%) in the adalimumab group at week 24; 153 (75.0%) in the guselkumab group vs 76 (50.3%) in the adalimumab group achieved an hf-PGA score of 0 (all P < .001). An f-PGA score of 0 or 1 was achieved by 196 patients (46.7%) in the guselkumab group vs 32 (15.2%) in the placebo group at week 16 (P < .001) and 252 (60.0%) in the guselkumab group vs 191 (64.3%) in the adalimumab group at week 24 (P = .11); 115 (27.4%) in the guselkumab group vs 83 (27.9%) in the adalimumab group achieved an f-PGA score of 0 (P = .63).
Conclusions and Relevance
Compared with adalimumab, guselkumab was associated with significant improvement in psoriasis on the scalp and palms and/or soles; magnitude of improvement in fingernails did not differ between treatments. These results may help dermatologists make treatment decisions for patients with psoriasis in difficult-to-treat body regions.
ClinicalTrials.gov Identifiers: NCT02207231 and NCT02207244
Significant progress in the treatment of moderate to severe psoriasis with biologic therapy has been made in recent years. Certain body regions, however, including the scalp, palms and/or soles, and nails, remain challenging to treat. These areas are commonly affected in psoriasis, with reported scalp psoriasis involvement in 50% to 80% of patients and nail psoriasis involvement in 10% to 50% of patients, with higher numbers in those with psoriatic arthritis or more severe disease.1-3 Estimates vary from 3% to 41% of patients with involvement of the palms and/or soles.4 Of note, disease in these areas is associated with greater disability and reduced quality of life.2,5-7 Multiple therapies, including topical agents, phototherapy, traditional systemic agents, and biologic therapies, have had variable success in treating these regional forms of psoriasis.1,2,8,9 Data from larger controlled studies, which have been limited until recently, suggest that the results for biologic agents are more promising.10-15
The significantly better efficacy of guselkumab, an interleukin 23 inhibitor (Janssen Research & Development, LLC), compared with placebo and adalimumab as well as a reassuring safety profile for guselkumab were reported in 2 pivotal, phase 3 trials (VOYAGE 1 and VOYAGE 2).11,12 In this article, we present pooled efficacy data for regional psoriasis end points initially reported in these studies, which are derived from one of the largest clinical trial databases for psoriasis. In addition, complete clearance of disease that involves the scalp, nails, and palms and/or soles as well as the correlation between regional disease end points and patient-reported outcomes were assessed.
Detailed methods and patient characteristics for the VOYAGE 1 and VOYAGE 2 studies have been reported previously.11,12 Patient inclusion and exclusion criteria were identical for both studies. Eligible patients (≥18 years of age) had a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study agent, a baseline Psoriasis Area and Severity Index (PASI) score (range of 0-72, with lower scores indicating less severe disease) of at least 12, an Investigator’s Global Assessment (IGA) score (range of 0-4, with 0 indicating cleared and 4 indicating severe) of at least 3, and at least 10% body surface area involved with psoriasis; they also had to be candidates for phototherapy or systemic psoriasis treatments. The studies were conducted from November 3, 2014, to May 19, 2016, at 101 (VOYAGE 1) and 115 (VOYAGE 2) global sites. This post hoc data analysis was performed from February 10, 2017, through November 15, 2017. For the PASI or IGA end points, the original analyses were intention to treat; however, for regional psoriasis, the intent was to focus on only patients with minimal regional diseases. The study protocols were approved by multiple institutional review boards or ethics committees (eg, Sterling Institutional Review Board), and all patients provided written informed consent before study procedures were initiated. These studies were conducted in accordance with current International Committee on Harmonization guidelines on Good Clinical Practice16 and applicable regulatory and country-specific requirements.
Both VOYAGE 1 and VOYAGE 2 were phase 3, multicenter, randomized, double-blind, placebo- and adalimumab-controlled studies. The study designs were identical through week 24. Patients were randomized using a permuted block method at baseline to receive guselkumab, 100 mg, at weeks 0, 4, 12, and 20; placebo at weeks 0, 4, and 12 followed by guselkumab, 100 mg, at weeks 16 and 20; or adalimumab, 80 mg, at week 0, 40 mg at week 1, and 40 mg every 2 weeks through week 23. Overall, 837 patients (329 in the guselkumab group, 334 in the adalimumab group, and 174 in the placebo group) were randomized in VOYAGE 1 and 992 (496 in the guselkumab group, 248 in the adalimumab group, and 248 in the placebo group) in VOYAGE 2. Detailed study designs through week 48 of both trials have been reported previously.11,12
Regional efficacy was assessed through week 24 using pooled data from VOYAGE 1 and VOYAGE 2. Scalp psoriasis was graded using the scalp-specific IGA (ss-IGA), which assesses lesions for degree of redness, thickness, and scaling on a 5-point scale, with 0 indicating absence of disease and 4 indicating severe disease (eTable 1 in the Supplement). Psoriasis on the palms and/or soles was evaluated using the Physician’s Global Assessment of the hands and/or feet (hf-PGA); severity of plaques on the palms and/or soles was also scored on a 5-point scale, with 0 indicating clear and 4 indicating severe (eTable 2 in the Supplement). Fingernail involvement with psoriasis was evaluated using the fingernail PGA (f-PGA), with rating of the overall condition of the fingernails also based on a 5-point scale, with 0 indicating clear and 4 indicating severe (eTable 3 in the Supplement). Fingernail psoriasis was also assessed using the target Nail Psoriasis Severity Index (NAPSI), in which the nail most affected by psoriasis (target nail) is divided into quadrants and graded for psoriasis of the nail matrix (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis) on a scale of 0 to 4 for a total score ranging from 0 to 8; a higher score indicates more severe disease (eTable 4 in the Supplement).17 Patient-reported outcomes were assessed using the Dermatology Life Quality Index (DLQI); a score of 0 or 1 indicates no effect of psoriasis or its treatment on health-related quality of life (HRQoL).18
Regional psoriasis scores were analyzed for patients with ss-IGA, f-PGA, and hf-PGA scores of 2 or more (mild or worse disease) at baseline. End points included the proportion of patients achieving clear or near-clear status (scores of 0 or 1) for the ss-IGA (absent or very mild scalp psoriasis), the hf-PGA (clear or almost clear psoriasis of the palms and/or soles), and the f-PGA (clear or minimal fingernail psoriasis) as well as the mean percentage of improvement in target NAPSI scores at weeks 16 and 24. Responders also had to achieve at least a 2-grade improvement from baseline in ss-IGA and hf-PGA scores. Complete clearance was assessed on the basis of the proportion of patients with a score of 0 for the ss-IGA, f-PGA, and hf-PGA and target NAPSI (100% improvement) at the same time points. Binary end points were analyzed using a Cochran-Mantel-Haenszel χ2 test stratified by study and investigator site, and continuous end points were analyzed using an analysis of variance model with study and investigator site as covariates. All statistical testing was performed using 2-sided analyses (α = .05). These analyses of pooled data were not multiplicity controlled, and all reported P values are nominal. Patients were considered to be nonresponders (binary end points) or had baseline values carried forward (continuous end points) if they had discontinued study treatment because of a lack of efficacy or an adverse event of worsening of psoriasis or if they had started a protocol-prohibited treatment that could improve psoriasis. Patients with missing data were treated similarly for binary variables, and the last observation was carried forward for continuous variables. A post hoc analysis was performed to evaluate the effect of improvement in regional disease on patients’ ability to achieve a DLQI score of 0 or 1 (no effect of psoriasis on HRQoL) at week 24 while adjusting for overall skin improvement across the entire body. A multiple logistic regression model using data from patients in the guselkumab and adalimumab treatment groups was used to test variables potentially associated with achieving a DLQI score of 0 or 1. Stepwise selection with significance levels of .10 was used to select the candidate variables for the final model. Candidate variables included PASI, IGA, ss-IGA, hf-PGA, and f-PGA responses (all at week 24) and treatment (guselkumab vs adalimumab). Odds ratios (ORs) and corresponding 95% CIs are presented based on the final model. P values were calculated using the Wald test performed at a 2-sided significance level of α = .05
At baseline, 1829 patients (mean [SD] age, 43.6 [12.4] years) were randomized across VOYAGE 1 and VOYAGE 2. Most patients were male (1300 [71.1%]), white (1498 [81.9%]), and overweight or obese (1392 [76.1%]). Of the 1829 randomized patients, 1576 (86.2%) had scalp psoriasis, 501 (27.4%) had psoriasis of the palms and/or soles, and 1049 (57.4%) had fingernail psoriasis at baseline. Among these patients, 1512 (82.7%) had a baseline score of 2 or higher on the ss-IGA, with 461 (25.2%) on the hf-PGA, and 928 (50.7%) on the f-PGA; all were included in the current analysis (Figure 1). Most patients in the active treatment groups (range, 92.5%-96.6%) completed the study agent through week 24 (Figure 1). Regional baseline psoriasis characteristics for the overall population were generally comparable across treatment groups (Table 1) and were consistent with those observed among patients with scalp, nail, and palm and/or sole psoriasis (eTables 5-8 in the Supplement).
The number of patients achieving absent or very mild scalp psoriasis (ss-IGA score of 0 or 1) with at least a 2-grade improvement from baseline in the guselkumab group was statistically significantly higher compared with that in the placebo group (560 [81.8%] vs 43 [12.4%], P < .001) at week 16. Likewise, the number of guselkumab-treated patients achieving an ss-IGA score of 0 or 1 was statistically significantly higher compared with adalimumab-treated patients at week 24 (582 [85.0%] vs 329 [68.5%], P < .001) (Table 2). Similarly, a statistically significantly higher number of guselkumab-treated patients achieved complete clearance of the scalp (ss-IGA score of 0) compared with placebo at week 16 (447 [65.3%] vs 29 [8.4%]) and adalimumab at week 24 (479 [69.9%] vs 270 [56.3%]) (both P < .001) (Figure 2).
The proportion of patients achieving clear or near-clear skin on the palms and/or soles (hf-PGA score of 0 or 1) with at least a 2-grade improvement from baseline was statistically significantly higher for guselkumab vs placebo at week 16 (154 [75.5%] vs 15 [14.2%]) and for guselkumab vs adalimumab at week 24 (164 [80.4%] vs 91 [60.3%]) (both P < .001) (Table 2). Similarly, a statistically significantly higher number of guselkumab-treated patients achieved complete clearance of the palms and/or soles (hf-PGA score of 0) compared with placebo at week 16 (131 [64.2%] vs 12 [11.3%]) and adalimumab at week 24 (153 [75.0%] vs 76 [50.3%]) (both P < .001) (Figure 2).
The number of patients achieving cleared or minimal fingernail psoriasis (f-PGA score of 0 or 1) was statistically significantly higher in the guselkumab group vs the placebo group at week 16 (196 [46.7%] vs 32 [15.2%], P < .001). The f-PGA responses were comparable in guselkumab- and adalimumab-treated patients at week 24 (252 [60.0%] vs 191 [64.3%], P = .11) (Table 2). A statistically significantly higher number of guselkumab-treated patients achieved complete fingernail clearance (f-PGA score of 0) compared with placebo at week 16 (52 [12.4%] vs 8 [3.8%], P < .001), whereas comparable proportions of guselkumab- and adalimumab-treated patients achieved f-PGA scores of 0 at week 24 (115 [27.4%] vs 83 [27.9%], P = .63) (Figure 2). Similarly, improvements in target NAPSI score were statistically significantly greater for the guselkumab group vs the placebo group at week 16 (mean improvement, 37.5% vs 0.7%; P < .001) and comparable between the guselkumab and adalimumab groups at week 24 (52.9% vs 51.2%, P = .96) (Table 2). The number of patients achieving the target NAPSI score of 0 (100% improvement) was statistically significantly higher for the guselkumab group compared with the placebo group at week 16 (76 [16.0%] vs 13 [5.4%], P < .001) and comparable between the guselkumab and adalimumab groups at week 24 (145 [30.6%] vs 108 [32.6%], P = .50) (Figure 2).
Logistic regression modeling showed that, among patients in the guselkumab and adalimumab treatment groups, the following factors were identified as indicators for achieving a DLQI score of 0 or 1 (no effect of psoriasis on HRQoL) at week 24: overall PASI response at week 24 (OR, 0.786; 95% CI, 0.721-0.858; P < .001), overall IGA response at week 24 (OR, 0.683; 95% CI, 0.548-0.850; P < .001), and ss-IGA response at week 24 (OR, 0.780; 95% CI, 0.652-0.932; P = .006). Conversely, treatment group and hf-PGA and f-PGA scores did not meet the significance level of 0.10 required for inclusion in the model.
Safety data were not analyzed separately for the regional disease populations studied here. However, on the basis of the results from the overall study populations in the VOYAGE 1 and VOYAGE 2 studies, common adverse events occurred in similar proportions among patients in each active treatment group. Serious adverse events and discontinuations attributable to adverse events occurred infrequently. Detailed descriptions of the safety data from each study have been previously published.11,12
In pooled analyses of prospectively defined regional psoriasis end points from the pivotal phase 3 studies (VOYAGE 1 and VOYAGE 2), we found that guselkumab was highly effective in treating the scalp, palms and/or soles, and fingernails. These combined trials comprise one of the largest clinical trial databases to date to evaluate regional psoriasis (>1800 patients) and include a comparator agent, adalimumab. Detailed assessments of regional forms of psoriasis were used to compare the efficacy of guselkumab with placebo and adalimumab. Guselkumab was superior to placebo with regard to the proportions of patients achieving near-complete and complete clearance of psoriasis of the scalp, palms and/or soles, and fingernails. Compared with adalimumab at 6 months, statistically significantly greater improvements were observed with guselkumab for near-complete and complete clearance of psoriasis of the scalp and palms and/or soles as well as complete clearance in these regions. Responses were comparable between the active treatment groups based on 2 measures of fingernail psoriasis (f-PGA and target NAPSI). Because nail psoriasis responds more slowly than skin disease and complete nail replacement is protracted, 6 months may be insufficient to assess the ultimate effect of treatment on nail psoriasis.19,20
Reported prevalence rates of regional psoriasis have been variable. Data from historical estimates or clinical trials suggest that rates of involvement among patients with psoriasis vary from 50% to 80% for the scalp and 3% to 41% for the palms and/or soles.1-4,21,22 Nail psoriasis has been reported in 10% to 50% of patients,3,19,23 with more consistent rates of 60% to 82% observed in recent clinical studies.13,15,24-27 In VOYAGE 1 and 2, more than 85% of patients had scalp psoriasis, less than 30% had psoriasis of the palms and/or soles, and nearly 60% had fingernail psoriasis; these rates are comparable to those reported in other clinical studies of patients with moderate to severe psoriasis, indicating that psoriasis in these areas is common. Although we collected data regarding any involvement of these regions in all enrolled patients, only those with at least mild disease were analyzed to ensure that measurable changes could be evaluated.
Guselkumab was highly effective in treating psoriasis in the studied areas, particularly the scalp and palms and/or soles, with complete clearance achieved in approximately 70% of patients. Furthermore, guselkumab achieved responses superior to adalimumab, a commonly prescribed anti–tumor necrosis factor α antibody. Although multiple reports9,10,13-15,22,24-29 on treatment of the scalp, palms and/or soles, and nails have been published, results are difficult to compare across studies because of differences in study designs and patient characteristics. Although patient populations are well described and assessment tools are standardized for moderate to severe skin psoriasis in general, it is particularly challenging to compare results of regional psoriasis studies because they are highly variable for psoriasis of the scalp, palms and/or soles, and nails. Thus, the strengths of the data from VOYAGE 1 and VOYAGE 2 reported here, which can be used as a benchmark for future studies on this topic, derive from the use of the following: (1) a large standardized population with moderate to severe psoriatic disease, (2) the commonly used tools for assessment of regional psoriasis, and (3) an active comparator study design.
Our findings also indicate that improvements in scalp psoriasis were associated with improvements in patient-reported HRQoL outcomes after adjusting for overall psoriasis across the entire body (IGA and PASI). This association between greater improvements in HRQoL (ie, DLQI score of 0 or 1, indicating no effect of psoriasis on HRQoL) and clinical responses in scalp psoriasis (ss-IGA) may be attributable to the high visibility and consequent psychosocial effect of scalp lesions. Of interest, improvements in hand, foot, and fingernail psoriasis (as measured by hf-PGA and f-PGA) were not identified as indicators of improvements in HRQoL outcomes. However, the DLQI used to measure changes in HRQoL in these studies is not psoriasis specific and, thus, is not necessarily designed to evaluate psoriasis in these particular body regions.
Some limitations of this study should be noted. VOYAGE 1 and 2 included only patients with moderate to severe psoriasis, and responses may vary in patients with mild psoriasis. In addition, these data are limited to the 24 weeks during which the study designs were identical.
In a large, pooled psoriasis data set from the VOYAGE 1 and 2 studies, we found that guselkumab was effective in treating regional psoriasis of the scalp, palms and/or soles, and fingernails. Guselkumab was superior to adalimumab for the treatment of psoriasis of the scalp and palms and/or soles and comparable to adalimumab for the fingernails. Because these body areas are commonly involved in patients with moderate to severe psoriasis, dermatologists should consider these results when making future treatment decisions.
Accepted for Publication: March 3, 2018.
Published Online: May 16, 2018. doi:10.1001/jamadermatol.2018.0793
Open Access: This article is published under the JN-OA license and is free to read on the day of publication.
Corresponding Author: Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, 9495 SW Locust St, Ste G, Portland, OR 97223 (email@example.com).
Author Contributions: Drs Foley and Blauvelt had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Gordon, Wasfi, Randazzo, Song, Li, Shen.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Song.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Gordon, Li, Shen.
Administrative, technical, or material support: Randazzo, Song.
Study supervision: Song, Blauvelt.
Conflict of Interest Disclosures: Dr Foley reported serving as a consultant, investigator, speaker, and/or adviser for and/or receiving travel grants from Galderma, LEO Pharma, Janssen, Eli Lilly and Company, 3M/iNova/Valeant, GlaxoSmithKline, AbbVie, Biogen Idec, Schering-Plough/MSD, Pfizer, Amgen, Novartis, Celgene, Dermira, Boehringer Ingelheim, Cutanea, Celtaxsys, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, and BMS. Dr Gordon reported receiving research support from AbbVie, Boehringer-Ingelheim, Eli Lilly and Company, Janssen, and Novartis and working as a consultant for AbbVie, Amgen, Boehringer Ingelheim, Dermira, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, and Pfizer. Dr Griffiths reported receiving honoraria and/or grants as an investigator, speaker, and/or advisory board member for Abbvie, Almirall, BMS, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Pfizer, Sandoz, Sanofi- Regeneron, Sun Pharma, and UCB. Drs Wasfi, Randazzo, Song, Li, and Shen reported being employed by Janssen Research and Development LLC and owning stock in Johnson & Johnson, of which Janssen is a subsidiary. Dr Blauvelt reported serving as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Allergan, Almirall, Amgen, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly and Company, Genentech/Roche, GlaxoSmithKline, Janssen, LEO Pharma, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB, Valeant, and Vidac and as a paid speaker for Eli Lilly and Company, Janssen, Regeneron, and Sanofi Genzyme. Dr Griffiths reported being a National Institutes of Health research senior investigator. No other disclosures were reported.
Funding/Support: This study was supported by Janssen Research and Development LLC.
Role of the Funder/Sponsor: Janssen Research and Development LLC had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: Cynthia Arnold, BSc, CMPP, Janssen Scientific Affairs LLC, Spring House, Pennsylvania, and Cynthia Guzzo, MD, HireGenics, Duluth, Georgia, provided editorial assistance and writing support, and Yin You, MS, Janssen Research and Development LLC, Spring House, Pennsylvania, provided statistical support. Dr Guzzo was compensated for her work.