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

Second Affiliated Hospital of Wenzhou Medical University

Status: Completed

Conditions: IBD (Inflammatory Bowel Disease)

Treatments: Drug: Optimized Treatment (OPT)

Study type: Observational

Funder types: Other

Identifiers

NCT06856031

SAHoWMU-CR2025-01-204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.