OSAKA, Japan, and CAMBRIDGE, Mass., October 19, 2026
Takeda (TSE: 4502; NYSE: TAK) announced new results from the Phase 4 VERDICT trial (NCT04259138) showing that treating adults with moderate-to-severe ulcerative colitis (UC) with intravenous ENTYVIO® (vedolizumab) to achieve disease clearance significantly prolonged the time to a first UC-related complication compared with targeting symptomatic remission alone. The study reported a hazard ratio of 0.33 (95% confidence interval: 0.17–0.67; P=0.0014), corresponding to a nearly 70% lower risk of UC-related complications for patients assigned to the more stringent treatment target. Presented at United European Gastroenterology (UEG) Week 2026 and published in the United European Gastroenterology Journal, VERDICT provides prospective, randomized evidence supporting a treat-to-target approach that addresses symptoms, visible intestinal healing and microscopic inflammation. The trial enrolled 672 adults and evaluated whether achieving deeper remission could improve longer-term disease control and reduce complications.
Disease Clearance Target Associated With Fewer UC Complications
VERDICT compared three corticosteroid-free treatment targets: symptomatic remission alone; symptomatic plus endoscopic remission; and disease clearance, defined as the combination of symptomatic, endoscopic and histologic remission. Treatment was adjusted using ENTYVIO-based algorithms, which could include increased dosing frequency, to help patients reach their assigned targets. The primary analysis compared the time to a first UC-related complication between the disease-clearance group and the symptomatic-remission group, with follow-up extending up to 80 weeks after target achievement. The reported hazard ratio of 0.33 favored disease clearance, with the difference reaching statistical significance. Across the achieved-target population, 400 of 672 randomized patients reached their assigned corticosteroid-free target by Week 48. Target achievement varied by group: 74.1% in the symptomatic-remission group, 56.3% in the symptomatic-plus-endoscopic group and 52.1% in the disease-clearance group. Among patients achieving symptomatic and endoscopic remission, more than 80% also achieved histologic remission at Week 48. The study recorded 51 UC-related complications, with use of rescue therapy the most frequent. Time to complication was similar between the symptomatic-plus-endoscopic and disease-clearance groups, with a reported hazard ratio of 1.10 (95% CI: 0.45–2.69; P=0.8023).
Week 16 Findings and Evidence of Intestinal Tissue Repair
Takeda also highlighted findings showing that more than half of ENTYVIO-treated patients who met their assigned treatment target achieved disease clearance by Week 16. Disease clearance requires remission without corticosteroids alongside endoscopic healing of the intestinal lining and histologic remission at the microscopic level. The company described VERDICT as the first randomized ulcerative colitis trial to evaluate this stringent treatment target under a prespecified hypothesis and the first to provide prospective evidence linking the target with a longer time to disease-related complications. Additional exploratory analyses presented at UEG Week examined molecular changes associated with early disease clearance. Proteomic and transcriptomic analyses identified distinct molecular patterns in largely biologic-naïve patients who achieved disease clearance by Week 16, including changes in pathways related to inflammation, mucosal homeostasis and tissue repair. These findings may help researchers understand the biological processes associated with deeper remission, although further investigation is needed to establish their clinical implications. Lead study author Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine at Western University and Chief Medical Officer of Alimentiv, said the results support evaluating deeper, durable disease control as a treatment goal.
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ENTYVIO Safety Profile Remains Consistent With Previous Data
The safety profile observed during the 96-week study period was generally consistent with previously reported ENTYVIO data, with no new safety signals identified. Adverse event rates were similar across the three treatment groups and were not affected by treatment escalation or more frequent dosing used to achieve stricter targets. Common adverse events reported at a frequency of at least 5% included ulcerative colitis, anemia, haematochezia, COVID-19 infection, influenza, nasopharyngitis and arthralgia. ENTYVIO is a biologic therapy that targets the α4β7 integrin, blocking its interaction with MAdCAM-1, which is primarily expressed on gut endothelial cells. This gut-focused mechanism is intended to reduce inflammation in the gastrointestinal tract. The therapy is approved for adults with moderately to severely active ulcerative colitis and Crohn’s disease in multiple markets, with intravenous and subcutaneous formulations available depending on the jurisdiction. Takeda said the VERDICT findings reinforce the importance of addressing both symptoms and intestinal inflammation when setting treatment goals. The results support disease clearance as a clinically relevant target, while treatment decisions should continue to account for individual patient circumstances, response and safety.
Source::Takeda,,press release
