Guselkumab Efficacy by Psoriasis Disease Severity and Treatment History: VOYAGE 1 and 2 Post Hoc Analyses
February 2025 | Volume 24 | Issue 2 | 196 | Copyright © February 2025
Published online January 30, 2025
Kenneth B. Gordon MDa, Joseph F. Merola MD MMScb, Peter Foley MDc,d, Olivia Choi MD PhDe, Daphne Chan PhDe, Megan Miller MPHf, Yin You MSf, Yaung-Kaung Shen PhDf, Hetal V. Patel PharmDe, Andrew Blauvelt MD MBAg
aMedical College of Wisconsin, Milwaukee, WI
bUT Southwestern Medical Center, Dallas, TX
cThe University of Melbourne, St. Vincent’s Hospital Melbourne, Fitzroy, VIC, Australia
dProbity Medical Research Inc., Skin Health Institute, Carlton, VIC, Australia
eJohnson & Johnson, Horsham, PA
fJohnson & Johnson, Spring House, PA
gOregon Medical Research Center, Portland, OR
Abstract
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
INTRODUCTION
Psoriasis is a chronic, systemic, immune-mediated, inflammatory disease that often negatively affects physical and emotional health-related quality of life.1,2 Current guidelines for the treatment of moderate-to-severe plaque psoriasis recommend the use of biologics, including tumor necrosis factor-α (TNF), interleukin (IL)-12/23, IL-17, and IL-23 inhibitors.1 For most patients, biologic therapy is highly effective, but the response to treatment can decrease over time and can be affected by demographic characteristics, co-morbidities, disease severity, and previous treatment exposure.3,4 Accordingly, it is important to confirm that newer classes of biologic agents provide high levels of durable clinical response across a broad range of patient populations.
Guselkumab, a fully human immunoglobulin G1γ monoclonal antibody that selectively inhibits the IL-23 p19 subunit, is approved for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis. In the pivotal Phase 3 VOYAGE 1 and VOYAGE 2 studies in patients with moderate-to-severe psoriasis, guselkumab was well tolerated and provided superior efficacy compared with adalimumab for up to 1
