NCT06856031

the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Ulcerative Colitis

A Retrospective Analysis on the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Patients With Ulcerative Colitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The drug retention rate of vedolizumab for ulcerative colitis decreases with time. This study analyzed the long-term drug retention rate and its influencing factors in patients with moderately to severely active ulcerative colitis treated with vedolizumab.

Detailed description

Vedelizumab is a humanized monoclonal antibody that specifically recognizes α4β7 heterodimer, selectively blocks the interaction between mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on intestinal blood vessels and α4β7 integrins on the surface of lymphocytes, inhibiting the migration of lymphocytes to the gastrointestinal mucosa and thus exerting anti-inflammatory effects. The regimen of vedolizumab therapy for the treatment of ulcerative colitis is intravenous vedolizumab (300 mg) at weeks 0, 2, and 6 for induction therapy, followed by intravenous vedolizumab (300 mg) every 8 weeks for maintenance therapy. This study analyzed the long-term drug retention rate and its influencing factors in moderately and severely active UC patients treated with VDZ, aiming to provide a more precise and personalized treatment plan for UC patients before initiating VDZ therapy, and to better predict drug efficacy as well as retention rate.

Conditions

• IBD (Inflammatory Bowel Disease)

Interventions

Type	Name	Description
DRUG	Optimized Treatment (OPT)	After induction therapy with intravenous vedolizumab (300 mg) at weeks 0, 2, and 6, PRO2 was assessed to determine the patient's response and an individualized treatment plan was formulated: vedolizumab was reinfused intravenously (300 mg) every 4 weeks if PRO2 was reduced by \<50% from baseline or was still in the moderately-severe active phase of PRO2.

Timeline

• Start date: 2020-11-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

1 site across 1 country: China