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Janssen announced new findings from VOYAGE 2 and NAVIGATE, two pivotal Phase 3 studies evaluating guselkumab for the treatment of moderate to severe plaque psoriasis.
VOYAGE 2 was a randomized, double-blind, placebo- and active-comparator controlled Phase 3 trial evaluating the safety and efficacy of guselkumab compared to placebo and adalimumab and of guselkumab maintenance therapy compared with withdrawal of therapy in 992 adults with moderate to severe plaque psoriasis. The co-primary endpoints were the percentage of patients who achieved an Investigator’s Global Assessment (IGA) score of 0 (cleared) or 1 (minimal disease) and a Psoriasis Area Severity Index (PASI) 90 score (near complete skin clearance).
Results from VOYAGE 2 showed that treatment with guselkumab was associated with significant improvements in skin clearance vs. placebo, and significantly greater improvements vs. adalimumab. Both co-primary endpoints were met at Week 16, with 84.1% of guselkumab-treated patients achieving an IGA score of 0 or 1 and 70% achieving PASI 90 score compared to 8.5% and 2.4%, respectively, in placebo-treated patients (P<0.001 for both). Additionally, significantly higher proportions of patients in the guselkumab arm vs. the adalimumab arm achieved IGA 0/1 (84.1% vs. 67.7%, respectively) and PASI 90 (70% vs. 46.8%, respectively) at Week 16. Guselkumab continued to demonstrate superiority compared to adalimumab at Week 24 for both endpoints. These findings are consistent with the previously presented VOYAGE 1 Phase 3 study results.
NAVIGATE was a randomized, multicenter, double-blind Phase 3 trial evaluating the efficacy and safety of guselkumab vs. ustekinumab in 871 adults with moderate to severe plaque psoriasis who had an inadequate response with 16 weeks of ustekinumab. Patients who were considered inadequate responders (IGA score ≥2) at Week 16 were either switched to guselkumab or continued ustekinumab therapy. The primary endpoint was the percentage of patients who achieved an IGA score of 0 or 1.
Patients who switched to guselkumab in NAVIGATE showed significantly greater improvements in skin clearance between Weeks 28 and 40 compared with patients who continued to receive ustekinumab. Patients in the guselkumab arm had twice as many office visits with ≥2 point improvement in IGA from Week 16, and an IGA score of 0 or 1 (1.5 and 0.7 respectively; P<0.001).
In both studies, the overall rates of adverse events (AE) were comparable among the treatment arms. In the VOYAGE 2 trial, 44.8%, 47.6% and 48.4% of patients receiving placebo, guselkumab and adalimumab, respectively, reported at least one AE through Week 16. In addition, 58.3% guselkumab-treated patients and 62.9% of adalimumab-treated patients reported at least one AE through Week 28. For the NAVIGATE trial, AEs were reported in 64.4% of guselkumab-treated patients and 55.6% ustekinumab-treated patients through Week 60.
Findings from these studies are being presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting on March 3-7. Results through Week 48 for both VOYAGE 1 and VOYAGE 2 were recently published in the Journal of the American Academy of Dermatology.
Guselkumab is a subcutaneous human monoclonal antibody that specifically targets interleukin (IL)-23.
For more information call (800) 526-7736 or visit Janssen.com.
