ENTYVIO treat-to-target strategy reduces ulcerative colitis complication risk in Phase IV VERDICT trial
Posted on October 19, 2026
Takeda has reported new Phase IV data showing that treating adults with ulcerative colitis toward deeper disease clearance with ENTYVIO, also known as vedolizumab, significantly prolonged the time to disease-related complications compared with targeting symptomatic remission alone.
The findings come from the VERDICT study and were presented at United European Gastroenterology Week 2026.
VERDICT is the first prospective randomised trial to assess whether increasingly stringent treatment targets can influence longer-term outcomes in adults with moderate to severe ulcerative colitis.
Patients were assigned to one of three corticosteroid-free treatment targets.
The first group aimed for symptomatic remission, the second targeted symptomatic plus endoscopic remission, while the third aimed for disease clearance, defined as simultaneous symptomatic, endoscopic and histologic remission without corticosteroid use.
Treatment was escalated using ENTYVIO-based strategies when patients had not achieved their assigned target.
The primary analysis compared patients who achieved disease clearance with those who achieved symptomatic remission alone.
Patients in the disease clearance group experienced a significantly longer time to their first ulcerative colitis-related complication.
The hazard ratio was 0.33, with a 95% confidence interval of 0.17 to 0.67 and a p value of 0.0014.
Takeda said this represented an approximately 70% reduction in the risk of ulcerative colitis-related complications for patients treated to disease clearance.
Complications included hospitalisation, colectomy, rescue therapy and other treatment or disease-related events.
Among 672 randomised patients, 400, or almost 60%, achieved their assigned corticosteroid-free target by week 48.
In the symptomatic remission group, 74.1% achieved their assigned target.
The corresponding rate was 56.3% among patients targeting symptomatic and endoscopic remission and 52.1% among those targeting full disease clearance.
Among patients who achieved symptomatic and endoscopic remission, more than 80% also achieved histologic remission by week 48.
Time to an ulcerative colitis-related complication was similar between the groups targeting symptomatic plus endoscopic remission and complete disease clearance.
A total of 51 ulcerative colitis-related complications were recorded, with rescue therapy representing the most frequent event.
Vipul Jairath, MBChB, DPhil, Professor of Medicine at Western University and lead study author, said the findings suggest that treating toward deeper levels of remission may influence the longer-term course of ulcerative colitis.
He said VERDICT provides evidence that disease clearance can be achieved and may represent a clinically relevant treatment target.
Vijay Yajnik, Vice President of Global Medical Affairs for Gastrointestinal and Inflammation at Takeda, said symptom improvement does not necessarily reflect the level of inflammation remaining in the intestine.
He said the study supports the use of deeper measures of disease control that assess both visible and microscopic healing.
Safety findings over 96 weeks were generally consistent with the established profile of ENTYVIO.
No new safety signals were identified, and adverse event rates were similar between treatment groups regardless of treatment escalation or increased ENTYVIO dosing frequency.
The most commonly reported adverse events included ulcerative colitis, anaemia, haematochezia, COVID-19 infection, influenza, nasopharyngitis and arthralgia.
Additional VERDICT analyses examined molecular changes associated with early disease clearance.
Proteomic and transcriptomic assessments in biologic-naive patients identified changes involving inflammatory pathways, mucosal homeostasis and tissue repair by week 16.
Takeda said the findings could help improve understanding of the biological processes associated with deeper disease control in ulcerative colitis.
Related Topics and Keywords
Biopharma, clinical trials, corticosteroid free remission, disease clearance, endoscopic remission, entyvio, gastroenterology, gut healing, histologic remission, IBD, inflammatory bowel disease, pharma news, Phase IV, symptomatic remission, Takeda, treat to target, UEG Week 2026, ulcerative colitis, Vedolizumab, VERDICT
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