Efficacy of guselkumab compared with adalimumab and placebo for psoriasis in specific body regions: A secondary analysis of 2 randomized clinical trials
JAMA Dermatology May 22, 2018
Foley P, et al. - Researchers assessed the impact of guselkumab on psoriasis in specific body regions. Association of guselkumab with significant improvement in psoriasis on the scalp and palms and/or soles than adalimumab was seen; in fingernails, the magnitude of improvement did not differ between treatments. For patients with psoriasis in difficult-to-treat body regions, these results could help dermatologists make treatment decisions.
Methods
- Experts conducted VOYAGE 1 and VOYAGE 2, double-blind, placebo- and adalimumab-controlled studies of guselkumab at 101 and 115 global sites, respectively, from November 3, 2014, to May 19, 2016. /li>
- The participants included, demonstrated 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). <
- They performed this post hoc data analysis from February 10 through November 15, 2017.
- They randiomized patients 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]).
- Researchers evaluated the efficacy through week 24.
- 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 were the main end points.
Results
- As per data, out of 1,829 randomized patients (mean [SD] age, 43.6 [12.4] years; 1300 [71.1%] male, 1,498 [81.9%] white), 1,576 (86.2%) had psoriasis of the scalp; 501 (27.4%), palms and/or soles; and 1,049 (57.4%), fingernails.
- Data showed that at baseline, 1,512 (82.7%), 461 (25.2%), and 928 (50.7%) patients demonstrated a score of 2 or higher on the ss-IGA, hf-PGA, and f-PGA, respectively, and were included in the analysis.
- Findings suggested superiority of guselkumab 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 (bothP < .001); 479 (69.9%) in the guselkumab group vs 270 (56.3%) in the adalimumab group achieved an ss-IGA score of 0 (al lP < .001).
- Results demonstrated that 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).
- A total of 196 patients (46.7%) achieved an f-PGA score of 0 or 1 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)
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