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

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.

Study Overview

• Status: Completed
• Conditions: IBD (Inflammatory Bowel Disease)
• Intervention / Treatment: Drug: Optimized Treatment (OPT)

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.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).

Description

Inclusion Criteria:

1. Diagnosed with moderate to severe ulcerative colitis
2. Receiving treatment with vedolizumab

Exclusion Criteria:

1. Combination therapy with other biological agents, small molecule drugs, immunosuppressants or hormone therapy.
2. Combination of active tuberculosis, Clostridium difficile infection, cytomegalovirus infection, EBV infection, etc.
3. Combined with malignant tumors or autoimmune diseases (such as dry syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc.).

4. Combined with serious cardiovascular and cerebrovascular diseases or liver and renal insufficiency.

   • Loss of visit or clinical data ≥30% during the follow-up period.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug retention rates analyzed at weeks 54 of vedolizumab treatment	the drug retention rate of vedolizumab	at week 54
Drug retention rates analyzed at weeks 108 of vedolizumab treatment	the drug retention rate of vedolizumab	at week 108

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze the impact of baseline MES on VDZ drug retention rates	Analyze the difference in baseline MES between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). The Mayo endoscopic score (MES) was used to assess the degree of intestinal inflammation, with a score of MES=0 defined as mucosal healing, MES=1 as mild, MES=2 as moderate, and MES=3 as severe.	at week 54 and 108
Analyze the impact of baseline disease sites on VDZ drug retention rates	Analyze the difference in disease sites between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). Disease sites were categorized into proctitis (E1), left hemicolonitis (E2) and extensive colitis (E3) based on the Montreal UC phenotypic classification criteria.	at week 54 and 108
Analyze the impact of baseline modified Mayo score on VDZ drug retention rates	Analyze the difference in the baseline modified Mayo score between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). The modified Mayo score was employed to assess UC disease activity. A modified Mayo score of ≤5 was defined as mild activity, 6-10 as moderate activity, and ≥11 as severe activity.	at week 54 and 108
Analyze the impact of duration of disease on VDZ drug retention rates	Analyze the difference in duration of disease (in years) between VDZ-continued group and VDZ-discontinued group.	at week 54 and 108
Analyze the impact of baseline C-reactive protein in peripheral blood on VDZ drug retention rates	Analyze the difference in baseline C-reactive protein (mg/L) in peripheral blood between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analyze the impact of baseline erythrocyte sedimentation rate on VDZ drug retention rates	Analyze the difference in baseline erythrocyte sedimentation rate (mm/h) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analyze the impact of baseline 25(OH) D in peripheral blood on VDZ drug retention rates	Analyze the difference in baseline 25(OH) D in peripheral blood (ng/mL) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analyze the impact of baseline serum albumin in peripheral blood on VDZ drug retention rates	Analyze the difference in baseline serum albumin (g/L) in peripheral blood between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analysis of the impact of baseline absolute eosinophil count in peripheral blood on VDZ drug retention rates	Analyze the difference in baseline absolute eosinophil count in peripheral blood (×10^8) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analysis of the impact of baseline hemoglobin in peripheral blood on VDZ drug retention rates	Analyze the difference in baseline hemoglobin in peripheral blood (g/L) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analysis of the impact of baseline white blood cell count in peripheral blood on VDZ drug retention rates	Analyze the difference in baseline white blood cell count in peripheral blood (×10^9) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analysis of the impact of baseline platelet count in peripheral blood on VDZ drug retention rates	Analyze the difference in baseline platelet count in peripheral blood (×10^9) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment).	at week 54 and 108
Analysis of the impact of baseline body mass index on VDZ drug retention rates	Analyze the difference in baseline body mass index between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). Body Mass Index (BMI) is a numerical value derived from an individual's weight and height, calculated by dividing the weight in kilograms by the square of the height in meters (kg/m²). Baseline height (m) and weight (kg) of patients need be collected.	at week 54 and 108

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative colitis; vedolizumab; drug retention; influencing factors
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Ulcer; Inflammatory Bowel Diseases
• Other Study ID Numbers: SAHoWMU-CR2025-01-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No