Takeda has 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 percent 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, randomised evidence that disease clearance is an achievable and clinically relevant target in the treatment of moderate to severe UC. Results were presented during late-breaker and poster sessions at United European Gastroenterology (UEG) Week 2026 and published in the UEG Journal.

Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine, Western University, Alimentiv Chief Medical Officer and lead study author, said, “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. 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.”

VERDICT randomised adults with moderate to severe UC to 3 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 (hospitalisation, colectomy, use of rescue therapy, treatment-related, and other UC-related complications) between groups 3 and 1 up to 80 weeks after target achievement.

Vijay Yajnik, Vice President, Global Medical Affairs, GI and Inflammation, Takeda, said, “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. 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.”

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 (AEs) (≥5 percent) were UC, anemia, haematochezia, COVID-19 infection, influenza, nasopharyngitis and arthralgia.

Additional analyses from VERDICT also presented at UEG week explored molecular changes associated with early disease clearance. 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 UC can extend well beyond day-to-day symptoms. Over time, up to 30 percent of patients may experience complications, including painful flares, hospitalisation and surgery, that can disrupt their lives and take an emotional and financial toll. This underscores the importance of addressing not only symptoms but also facilitating gut healing with the goal of changing the course of disease to minimise long-term impact and improve outcomes.