First and Only Ulcerative Colitis Treat-to-Target Trial Shows Treating to Disease Clearance vs. Symptomatic Remission with ENTYVIO® (vedolizumab) Prolongs Time to First Disease-Related Complication
More than half of ENTYVIO patients who met their assigned treatment target reached disease clearance (composite of corticosteroid-free symptomatic, endoscopic and histologic remission) at Week 16
VERDICT is the first trial to provide macroscopic and microscopic evidence of intestinal tissue repair associated with disease clearance in largely bio-naïve patients treated with an advanced therapy
OSAKA, Japan & CAMBRIDGE, Mass., October 19, 2026--Takeda (TSE:4502/NYSE:TAK) announced new data from VERDICT (NCT04259138), showing that treating adults with intravenous ENTYVIO® (vedolizumab) to achieve corticosteroid-free (CSF) disease clearance versus CSF symptomatic remission alone, resulted in a significantly longer time to first ulcerative colitis (UC)-related complication (hazard ratio 0.33 [95% confidence interval 0.17-0.67]; P=0.0014), reducing UC complication risk by nearly 70 percent. VERDICT, a Phase 4 ENTYVIO clinical trial, provides the first prospective, randomized evidence that disease clearance is an achievable and clinically relevant target in the treatment of moderate to severe ulcerative colitis.1 Results were presented during late-breaker and poster sessions at United European Gastroenterology (UEG) Week 2026 and published in the United European Gastroenterology Journal.
"There has been increasing conversation about whether achieving deeper levels of remission – addressing both visible and microscopic inflammation – ameliorates the burden of ulcerative colitis in the long-term," said Vipul Jairath MBChB, DPhil, FRCP, FRCPC, Professor of Medicine at Western University, Alimentiv chief medical officer and lead study author. "VERDICT suggests that implementation of a treat-to-target strategy can change the disease course. It also expands the body of evidence for treating with ENTYVIO, with the goal of achieving deeper and durable disease control within 16 weeks."
"For people living with UC, symptom relief does not always tell the full story of what is happening beneath the surface. Achieving deep healing and disease control without corticosteroids is an important goal of treatment. The VERDICT data further support the strength of gut-focused ENTYVIO in achieving outcomes such as disease clearance – within 16 weeks of treatment initiation – while also adding new molecular and cellular evidence suggesting restoration of gut function in bio-naïve patients," said Vijay Yajnik, Vice President, Global Medical Affairs, GI & Inflammation at Takeda. "VERDICT reflects our commitment to generating evidence that aims to answer some of the most complex questions in ulcerative colitis treatment strategies and standards of care."