Efficacy of guselkumab within specific body regions in patients with moderate-to-severe plaque psoriasis: Results from the phase 3-VOYAGE 1 study
Objective: To compare efficacy of guselkumab (GUS) with placebo and adalimumab (ADA) in moderate-severe plaque psoriasis with involvement of the scalp, nails, hands, & feet.
Methods: VOYAGE-1 is a phase 3 study of GUS in moderate-severe plaque psoriasis. Patients were randomized to subcutaneous injections of placebo with crossover to GUS at wk16 (n=174); GUS(n=329); or ADA(n=334).
Results: Significantly greater proportions of GUS-treated patients achieved a scalp-specific Investigator Global Assessment score of 0/1 at wk16 (absent/very mild) vs placebo (83.4% vs 14.5%, p<0.001) and vs ADA at wks24 and 48 (84.5% vs 69.2% & 78.3% vs 60.5%), respectively (both p<0.001). At wk 16, 39.1% of GUS- vs 15.9% of placebo-treated patients (p<0.001) achieved a fingernail Physician Global Assessment (f-PGA) score of 0/1 (clear/minimal). The proportions of patients achieving f-PGA 0/1 were comparable for GUS vs ADA at wk24 (56.3% vs 62.4%) and significantly higher for GUS vs ADA at wk48 (74.7% vs 61.8%, p=0.038). Mean percent improvement in the Nail Psoriasis Severity Index (NAPSI) was significantly higher for GUS vs placebo (34.4 vs -0.93, p<0.001) at wk16 and comparable for GUS vs ADA at wk24 (49.8% vs 49.4%) and wk48 (68.1% vs 61.4%). Significantly higher proportions of GUS-treated patients achieved a hands &/or feet (hf)-PGA score of 0/1 (clear/almost clear) vs placebo at wk16 (73.3% vs 14.0%, p<0.001) and vs ADA at wk24 (78.9% vs 56.8%, p<0.001) and wk48 (75.6% vs 62.1%, p=0.045).
Conclusion: GUS was efficacious in treating the scalp, nails, hands and feet in patients with moderate-severe psoriasis.
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Dr. Andrew Blauvelt
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