CAMBRIDGE, Mass. — Takeda announced new Phase 4 clinical trial results showing that treating ulcerative colitis patients to achieve deeper levels of remission with ENTYVIO (vedolizumab) significantly reduced the risk of disease-related complications compared with targeting symptom relief alone.
The findings from the VERDICT trial demonstrated that patients who achieved corticosteroid-free disease clearance, including symptomatic, endoscopic and histologic remission, experienced a nearly 70% lower risk of ulcerative colitis-related complications than those who achieved symptomatic remission alone.
The results were presented at United European Gastroenterology Week 2026 and published in the United European Gastroenterology Journal.
VERDICT is the first prospective, randomized trial to evaluate whether achieving deeper remission can improve long-term outcomes in adults with moderate to severe ulcerative colitis.
“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, professor of medicine at Western University, chief medical officer of Alimentiv 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,” Jairath added.
The study randomized 672 adults with moderate to severe ulcerative colitis into three treatment groups targeting increasingly stringent levels of remission: symptom relief, symptom relief combined with endoscopic remission, and complete disease clearance that also included histologic remission.
Treatment was adjusted according to each patient’s assigned target using ENTYVIO-based treatment strategies, including more frequent dosing when necessary.
By Week 48, nearly 60% of patients had achieved their assigned treatment target. Among those assigned to the disease-clearance group, 52.1% reached the most stringent remission target, compared with 74.1% achieving symptomatic remission in the least stringent group.
Patients in the disease-clearance group experienced a significantly longer time to their first ulcerative colitis-related complication, including hospitalization, surgery or the need for rescue therapy. The benefits were evaluated for up to 80 weeks after patients achieved their treatment targets.
Additional analyses showed that 57% of ENTYVIO-treated patients who achieved their assigned target by Week 16 reached disease clearance.
The researchers also examined molecular changes in patients who achieved early disease clearance. Proteomic and transcriptomic analyses identified changes associated with reduced inflammation, improved intestinal tissue repair and restoration of gut function.
“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,” said Vijay Yajnik, vice president of Global Medical Affairs, Gastrointestinal and Inflammation at Takeda.
“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,” Yajnik added.
Ulcerative colitis is a chronic inflammatory bowel disease that can cause abdominal pain, bleeding and diarrhea. Over time, some patients develop complications requiring hospitalization or surgery.
The trial also found that ENTYVIO maintained a safety profile consistent with previous studies through 96 weeks, with no new safety concerns identified. Common adverse events included ulcerative colitis, anemia, gastrointestinal bleeding, respiratory infections and joint pain.
Takeda said the findings provide additional evidence supporting a treatment strategy focused on achieving deeper and more sustained remission rather than relying solely on symptom improvement.
