Johnson & Johnson’s Janssen Research & Development has reported a positive outcome from the first of the three pivotal Phase III Voyage I studies of guselkumab compared with adalimumab to treat adults with moderate-to-severe plaque psoriasis.
Guselkumab has been developed as a human monoclonal antibody that targets the protein interleukin (IL)-23.
Adalimumab is an anti-TNF-alpha treatment product.
The Voyage I trial is the Phase III, randomised, double-blind, placebo and active comparator-controlled study which intends to determine the safety and efficacy of guselkumab compared with adalimumab and placebo.
The patients were treated with placebo at weeks zero, four and 12 while being administered with guselkumab in between.
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The study's co-primary endpoints were to achieve improvement in the symptoms of the disease and Psoriasis Area Severity Index (PASI 90, near complete skin clearance) response induced by guselkumab against placebo.
The secondary endpoints were measured at weeks 24 and 48, while the safety of its administration was assessed through week 48.
Results from the Voyage I trial showed that it met the co-primary endpoints with a significant proportion of patients achieving cleared / minimal disease when compared to placebo.
Guselkumab has also demonstrated superiority against adalimumab in the course of 48 weeks of treatment.
University of Manchester dermatology foundation professor Chris Griffiths said: "The high and durable rates of response in skin clearance were associated with significant improvements in quality of life among patients treated with guselkumab.
"Results from the VOYAGE I study show the promise of guselkumab, an IL-23 inhibitor, as a future therapeutic for plaque psoriasis, an immune-mediated disease."
Guselkumab is also undergoing a Phase II trial to treat moderately to severely active psoriatic arthritis.
Image: Psoriasis of a fingernail. Photo: courtesy of Seenms.
