Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials

Abstract

Importance: Psoriasis of the scalp, palms and/or soles, and nails is challenging to treat.

Objective: 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.

Exposures: 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.

Results: 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.

Trial registration: ClinicalTrials.gov Identifiers: NCT02207231 and NCT02207244.

Conflict of interest statement

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.

Figures

Figure 1.. Patient Flow Through Week 24

Patient flow for the entire VOYAGE 1 and VOYAGE 2 populations have been reported previously., 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.

Figure 2.. Patients Achieving Complete Clearance of Scalp, Palms and/or Soles, and Fingernail Psoriasis at Week 24

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.