Japan-based biopharmaceutical company Takeda (TSE: 4502) (NYSE: TAK) announced on Monday that positive Phase IV VERDICT trial results show that treating adults with moderate to severe ulcerative colitis with ENTYVIO (vedolizumab) to achieve disease clearance extended the time to first disease-related complication compared with targeting symptom remission alone. The approach reduced the risk of complications by nearly 70%, with a hazard ratio of 0.33.
The trial involved 672 patients and compared three increasingly stringent treatment targets: symptom remission, symptom and endoscopic remission, and disease clearance combining corticosteroid-free symptomatic, endoscopic and histologic remission. Nearly 60% of patients achieved their assigned target by Week 48, while more than half of those meeting their assigned target achieved disease clearance by Week 16.
Safety profiles were similar across the groups over 96 weeks, with no new safety signals identified. Additional exploratory analyses found molecular changes associated with early disease clearance, including pathways linked to inflammation, mucosal homeostasis and tissue repair.
The findings were presented at United European Gastroenterology Week 2026 and published in the United European Gastroenterology Journal. VERDICT is the first prospective, randomised trial to provide evidence that disease clearance is an achievable treatment target associated with a longer time to ulcerative colitis-related complications.
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