Guselkumab Efficacy by Psoriasis Disease Severity and Treatment History: VOYAGE 1 and 2 Post Hoc Analyses.

Background: The pivotal Phase 3 VOYAGE 1 and VOYAGE 2 studies established the robust efficacy and safety of guselkumab for up to 5 years in patients with moderate-to-severe psoriasis. Here, the long-term efficacy of guselkumab by baseline disease severity and treatment history was analyzed using pooled data from the VOYAGE studies.

Methods: Patients were randomized to guselkumab 100 mg every 8 weeks, placebo with week 16 crossover to guselkumab, or adalimumab with week 52 crossover to guselkumab (VOYAGE 1) or week 28-76 randomized withdrawal/re-treatment (VOYAGE 2); all patients then received open-label guselkumab through week 252. These post hoc analyses evaluated the Investigator’s Global Assessment of cleared/minimal (IGA 0/1) and Psoriasis Area and Severity Index (PASI) 90 responses from week 100-252 by baseline PASI (<20/≥20), IGA (=3/=4), body surface area (BSA; <20%/≥20%), and prior psoriasis treatments. Analyses used observed data after applying treatment failure rules.

Results: At all assessment timepoints from weeks 100-252, response rates were similar by baseline PASI <20 vs ≥20 (IGA 0/1: 82.0%-85.4% vs 81.1%-81.4%; PASI 90: 78.6%-81.1% vs 81.4%-83.8%), IGA=3 vs =4 (IGA 0/1: 82.7%-85.4% vs 77.6%-79.0%; PASI 90: 79.1%-82.7% vs 79.7%-82.9%), BSA <20% vs ≥20% (IGA 0/1: 82.5%-86.2% vs 81.1%-82.6%; PASI 90: 80.4%-82.7% vs 79.1%-82.0%), prior phototherapy no vs yes (IGA 0/1: 81.7%-84.3% vs 81.5%-83.8%; PASI 90: 82.2%-84.0% vs 77.5%-81.1%), prior nonbiologic use no vs yes (IGA 0/1: 81.1%-84.5% vs 81.9%-84.1%; PASI 90: 80.9%-83.0% vs 79.0%-82.0%), and prior biologic use no vs yes (IGA 0/1: 83.2%-85.3% vs 75.3%-79.5%; PASI 90: 82.2%-83.8% vs 71.2%-76.3%).

Conclusions: Durable guselkumab efficacy was sustained through 5 years of treatment among patient subpopulations irrespective of baseline disease severity or prior treatment history. J Drugs Dermatol. 2025;24(2):196-202. doi:10.36849/JDD.8344.