PASI Improvement in the First 12 weeks from the Phase 3 VOYAGE 1, VOYAGE 2, ORION and ECLIPSE Guselkumab Clinical Trials

Abstract

Background VOYAGE 1, VOYAGE 2, ORION, and ECLIPSE are Phase 3, double-blind trials of guselkumab 100 mg s/c at Weeks 0, 4, 12, then Q8W in moderate to severe plaque psoriasis. VOYAGE 1 and VOYAGE 2 included placebo and active comparator groups, ORION was placebo controlled, and ECLIPSE included an active comparator control group. The objective of this analysis was to evaluate PASI improvement among subjects treated with guselkumab over the induction phase of treatment. 

Methods Medan (interquartile) PASI improvements were evaluated at W4, W8, and W12. Analyses were performed using treatment failure rules, which considered non-responders as those who discontinued due to lack of efficacy or worsening of PsO, or use of a protocol prohibited PsO treatment.  Mean PASI improvement responses were also assessed.  

Results VOYAGE 1 included 329 subjects randomized to receive guselkumab, while VOYAGE 2, ORION and ECLIPSE trials included 496, 62, and 534 subjects randomized to guselkumab, respectively.  At W4, median PASI improvements were 56.70%, 56.85%, 37.15% and 67.50% for VOYAGE 1, VOYAGE 2, ORION and ECLIPSE, respectively.  At W8, median PASI improvements were 82.60%, 85.00%, 78.55% and 89.70% for the studies, respectively.  Similarly, at W12, median PASI improvements were 92.50%, 91.95%, 93.20% and 95.70%, respectively.    

Conclusions Median PASI improvements of approximately 60% were observed following 1st dose of guselkumab at W4, except ORION, and increased to greater than 90% after the 2nd dose of guselkumab at W12. This analysis provides information on the onset of action of guselkumab during the first few months of treatment.