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

Abstract

This secondary analysis of 2 randomized clinical trials evaluates the effect of guselkumab vs adalimumab or placebo on psoriasis in specific difficult-to-treat body regions.

Key Points

Question

How effective is guselkumab compared with adalimumab in treating psoriasis of the scalp, palms and/or soles, and fingernails?

Findings

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.

Meaning

Guselkumab is an important new treatment option for patients with psoriasis in difficult-to-treat 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 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