Guselkumab Goes Head-to-Head with TNF Blocker in Plaque Psoriasis Study
Janssen announced results from the first of three Phase 3 studies investigating guselkumab for the treatment of adults with moderate to severe plaque psoriasis. The data, which were presented at the 25th EADV Congress, mark the first-ever data from a head-to-head study of an interleukin (IL)-23 targeted biologic vs. an anti-tumor necrosis factor (TNF)-alpha treatment.
The VOYAGE 1 trial was a randomized, double-blind, placebo and active comparator-controlled trial (n=837). Data showed significantly higher proportions of patients receiving guselkumab achieving cleared/minimal disease vs. patients receiving placebo, as defined by ≥90% improvement in the Psoriasis Area Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (minimal disease) at Week 16. At Week 16, 85.1% of patients receiving guselkumab 100mg at Weeks 0 and 4 and then every 8 weeks achieved cleared IGA 0 or IGA 1 vs. 6.9% of patients in the placebo group (P<0.001). Also, 73.3% of patients receiving guselkumab had a PASI 90 response, or near complete skin clearance vs. 2.9% of patients receiving placebo (P<0.001).
The trial also included an active comparator arm evaluating guselkumab vs. adalimumab, which demonstrated the superiority of guselkumab for major study endpoints and through Week 48 of treatment. At Week 16, after 3 injections of guselkumab and 10 injections of adalimumab, significantly higher proportions of patients receiving guselkumab had IGA 0/1 (85.1%) and PASI 90 (73.3%) vs. patients receiving adalimumab (65.9% and 49.7%, respectively). At Week 24, significantly more patients in the guselkumab group achieved a PASI 90 response vs. the adalimumab group (80.2% vs. 53.0%).
Guselkumab is a subcutaneous anti-IL 23 human monoclonal antibody currently in late-stage development. A Phase 2 study investigating guselkumab for the treatment of moderately to severely active psoriatic arthritis is also ongoing.
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