Takeda Entyvio trial shows disease clearance cuts UC complication risk

Takeda Pharmaceutical (NYSE: TAK) announced results from the VERDICT trial (NCT04259138), a Phase 4 study of ENTYVIO (vedolizumab), showing that treating adults with moderate to severe ulcerative colitis to a corticosteroid-free disease clearance target significantly reduced the risk of UC-related complications compared with treating to symptomatic remission alone.

The trial found that patients in the disease clearance group experienced a longer time to first UC-related complication, with a hazard ratio of 0.33 (95% confidence interval 0.17–0.67; P=0.0014), representing a roughly 70% reduction in complication risk over up to 80 weeks after target achievement. The findings were presented at UEG Week 2026 in Barcelona and published in the United European Gastroenterology Journal.

VERDICT randomized 672 adults into three groups with increasingly stringent corticosteroid-free treatment targets: symptomatic remission, symptomatic plus endoscopic remission, and symptomatic plus endoscopic plus histologic remission, defined as disease clearance. Treatment was escalated using ENTYVIO-based algorithms if assigned targets were not met.

Among patients who achieved their assigned target, approximately 60% of all randomized patients met their target by Week 48. More than half of patients assigned to disease clearance achieved that target by Week 16. Among patients who achieved symptomatic and endoscopic remission, more than 80% also achieved histologic remission at Week 48.

Time to UC-related complication was similar between the symptomatic plus endoscopic remission group and the disease clearance group (HR 1.10; 95% CI 0.45–2.69; P=0.8023). Rescue therapy was the most frequently reported complication across the 51 total UC-related complications recorded.

The safety profile over 96 weeks was consistent with previously reported ENTYVIO data, with no new safety signals identified. Adverse event rates were similar across groups regardless of treatment escalation or dosing frequency. The most common adverse events reported at a rate of 5% or greater included ulcerative colitis, anemia, rectal bleeding, COVID-19, influenza, nasopharyngitis, and arthralgia.

Additional exploratory analyses presented at UEG Week identified molecular patterns in bio-naïve patients who achieved early disease clearance, including changes in pathways related to inflammation and tissue repair.

You May Also Be Interested In

• Coca-Cola picks Omnicom for North America, keeps WPP globally
• Scottie Resources closes final tranche of private placement
• MindWalk Holdings names CEO to oversee commercial team after CBO exit