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Could disease clearance become the optimal treatment target 
in moderate-to-severe ulcerative colitis (UC)?  

VERDICT is a study aiming to determine the optimal treatment target for patients with moderate-to-severe UC being treated with Entyvio (vedolizumab).1 Patients with UC were treated with Entyvio according to an algorithm that was dependent on the patient’s baseline UC therapy and randomised 
into three different groups, each aiming for a different treatment target:1

  • Group 1 – Corticosteroid-free symptomatic remission
  • Group 2 – Corticosteroid-free symptomatic and endoscopic remission
  • Group 3 – Corticosteroid-free symptomatic, endoscopic, and histological remission (also known as disease clearance)

The primary endpoint of the study was to determine whether disease clearance (group 3) is superior to solely targeting corticosteroid-free symptomatic remission (group 1), measured by time from treatment target achievement to a disease-related complication.1

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about the study design and key interim data.

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During an interim analysis of observed data (as of 29th February 2024), 612 patients were enrolled 
as follows:2

  • Group 1 – Corticosteroid-free symptomatic remission (n=154)
  • Group 2 – Corticosteroid-free symptomatic and endoscopic remission (n=198)
  • Group 3 – Corticosteroid-free symptomatic, endoscopic, and histological remission (n=260)

 

Entyvio achieved disease clearance treatment targets set out in VERDICT2

UC infographic

Adapated from Jairath V, et al. UEGW 20242

A higher proportion of bio-naïve patients achieved disease clearance treatment targets with Entyvio compared with bio-exposed patients2

UC infographic

Adapated from Jairath V, et al. UEGW 202411

Notes icon

Very common adverse events (≥1/10) include nasopharyngitis, headache, and arthralgia. Common adverse events (≥1/100 to ≤1/10) include upper respiratory tract infection, bronchitis, influenza, sinusitis, nausea, pyrexia, liver enzymes increased, fatigue 
and cough.3

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Infusion-related reactions (which may result in symptoms such as dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) have also been reported in patients treated with Entyvio.3 Hypersensitivity reactions 
have also been observed in patients switching from subcutaneous to intravenous administration.3

Warning icon

Entyvio is contraindicated in the case of active severe infections (such as tuberculosis, sepsis, cytomegalovirus, and listeriosis) and opportunistic infections (such as progressive multifocal leukoencephalopathy).3 Warnings are also given regarding infusion-related reactions, hypersensitivity, infections, malignancies, and live and oral vaccines.3

References:

  1. Jairath V, et al. BMJ Open Gastroenterol 2024;11:e001218.
  2. Jairath V, et al. Poster PP0556 presented at UEGW 2024.
  3. Entyvio Summary of Product Characteristics. Available at www.medicines.ie.

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