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

Abstract

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, placeboand 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 Ն12, Investigator's Global Assessment [IGA] score Ն3, and Ն10% 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 MEASURESEfficacy 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. RESULTSOf 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.

Efficacy and Safety of Biologics for Psoriasis and Psoriatic Arthritis and Their Impact on Comorbidities: A Literature Review

“…New biologic agents such as risankizumab [11], guselkumab [12][13][14][15][16], ixekizumab [17][18][19][20][21][22][23], and brodalumab [24,25] demonstrated high efficacy for patients with moderate-to-severe psoriasis. The percentage of patients who achieved more than a 90% reduction in the Psoriasis Area Severity Index (PASI) score at 16 weeks after initiating each treatment (PASI 90) was about 70%-80%, and that at 52 weeks was about 80%-90% in respective clinical trials.…”

Small Molecules and Biologics in the Treatment of Nail Psoriasis

“…Two multicenter, randomized, double-blind, placebo-and comparator-controlled clinical trials (VOYAGE 1 and VOYAGE 2) showed significantly greater improvements from baseline with guselkumab versus placebo (weeks 8 and 16) and versus ADA (week 24) [38]. A secondary analysis revealed that patients on guselkumab showed significant improvement in PsO of the scalp and palms and/or soles compared to patients on ADA, but the magnitude of improvement did not differ between the 2 treatments in patients' fingernails [39].…”

Practical recommendations for systemic treatment in psoriasis according to age, pregnancy, metabolic syndrome, mental health, psoriasis subtype and treatment history (BETA‐PSO: Belgian Evidence‐based Treatment Advice in Psoriasis; part 1)

“…From an efficacy perspective, we recommend in psoriasis patients with nail disease the TNF antagonists: infliximab, adalimumab, certolizumab pegol and etanercept; the IL12/23 inhibitor: ustekinumab; the IL23/ p19 inhibitors: guselkumab and risankizumab; the IL17 receptor blocker: brodalumab; the IL17 inhibitors: ixekizumab and secukinumab; and the synthetic drug, apremilast. [64][65][66][67] Also, the conventional drugs dimethylfumarate, cyclosporine and methotrexate are used based on clinical trial data. There is less robust evidence supporting the use of the conventional drugs cyclosporin, methotrexate and acitretin; however, it is our opinion that these drugs also provide benefit to psoriasis patients with nail disease especially in patients with limited skin involvement (PASI/BSA < 10).…”