Takeda Announces New Data From VERDICT Showing That Treating Adults With Intravenous ENTYVIO To Achieve Corticosteroid-Free Disease Clearance Resulted In Significantly Longer Time To First Ulcerative Colitis-Related Complication, Reducing UC Complication Risk By Nearly 70%

Takeda ((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."

VERDICT randomized adults with moderate to severe ulcerative colitis to three increasingly stringent CSF treatment targets (Group 1: symptomatic remission; Group 2: symptomatic + endoscopic remission; and Group 3: symptomatic + endoscopic + histologic remission, or disease clearance) to assess whether deeper levels of remission were associated with longer time to UC-related complications. Treatment was escalated based on assigned targets using ENTYVIO-based algorithms, which may have included an increase in dose frequency. The study’s primary outcome compared time to first UC-related complication (hospitalization, colectomy, use of rescue therapy, treatment-related, and other UC-related complications) between groups 3 and 1 up to 80 weeks after target achievement. Among the achieved-target population, key findings include:

After treatment with ENTYVIO, nearly 60% (400/672) of randomized patients achieved their assigned CSF target by Week 48 (Group 1: 137 [74.1%]; Group 2: 125 [56.3%]; Group 3: 138 [52.1%])
The primary endpoint was met with the disease-clearance group (Group 3) experiencing a longer time to first UC-related complication than the symptomatic-remission group (HR 0.33; 95% CI, 0.17–0.67; P=0.0014)
Treating to stringent composite targets (disease clearance) with ENTYVIO reduced UC complication risk by ~70%, up to 80 weeks after target achievement
Among patients achieving the CSF symptomatic + endoscopic remission target (Group 2), more than 80% also achieved histologic remission at Week 48
Time to UC-related complication was similar between patients in groups 2 and 3 (1.10 [0.45-2.69] P=0.8023)
51 UC-related complications occurred, with use of rescue therapy being the most frequent
Adverse event rates were similar across groups and unaffected by treatment escalation and more frequent ENTYVIO dosing to achieve more stringent targets
The safety profile observed throughout 96 weeks was generally consistent with previously reported data, with no new safety signals identified. The most common adverse events (≥5%) were ulcerative colitis, anaemia, haematochezia, COVID-19 infection, influenza, nasopharyngitis and arthralgia.1

Additional analyses from VERDICT also presented at UEG Week explored molecular changes associated with early disease clearance.2,3 Proteomic and transcriptomic analyses identified distinct molecular patterns among bio-naïve patients who achieved disease clearance by Week 16, including changes in pathways related to inflammation, mucosal homeostasis and tissue repair. These exploratory findings may contribute to a better understanding of the biology associated with disease clearance and warrant further investigation.

The impact of ulcerative colitis can extend well beyond day-to-day symptoms.4 Over time, up to 30 percent of patients may experience complications, including painful flares, hospitalization and surgery, that can disrupt their lives and take an emotional and financial toll.5,6 This underscores the importance of addressing not only symptoms but also facilitating gut healing with the goal of changing the course of disease to minimize long-term impact and improve outcomes.