Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions

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 2were, double-blind, placeboand adalimumab-controlled studies of guselkumab conducted at 101 and 115 global sites, respectively, from November 3, 2014, toMay 19, 2016. Patients had moderate to severe plaque psoriasis (Psoriasis Area and Severity Index score-12, Investigator's Global Asse [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, 100mg (weeks 0 and 4, then every 8 weeks); placebo followed by guselkumab, 100mg, starting at week 16; or adalimumab (80mg [week 0] and 40mg [week 1, then every 2 weeks]). MAIN OUTCOMES AND MEASURES Efficacywas assessed throughweek 24. End points included numbers of patients achieving scores of0or 1 (clear or near clear) or0(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