Clinical trial NCT06856031: the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Ulcerative Colitis
Official title: A Retrospective Analysis on the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Patients With Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD (Inflammatory Bowel Disease)
Keywords: Ulcerative colitis
vedolizumab
drug retention
influencing factors
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug retention rates analyzed at weeks 54 of vedolizumab treatment
timeFrame: at week 54
measure: Drug retention rates analyzed at weeks 108 of vedolizumab treatment
timeFrame: at week 108
Secondary outcomes:
measure: Analyze the impact of baseline MES on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analyze the impact of baseline disease sites on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analyze the impact of baseline modified Mayo score on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analyze the impact of duration of disease on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analyze the impact of baseline C-reactive protein in peripheral blood on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analyze the impact of baseline erythrocyte sedimentation rate on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analyze the impact of baseline 25(OH) D in peripheral blood on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analyze the impact of baseline serum albumin in peripheral blood on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analysis of the impact of baseline absolute eosinophil count in peripheral blood on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analysis of the impact of baseline hemoglobin in peripheral blood on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analysis of the impact of baseline white blood cell count in peripheral blood on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analysis of the impact of baseline platelet count in peripheral blood on VDZ drug retention rates
timeFrame: at week 54 and 108
measure: Analysis of the impact of baseline body mass index on VDZ drug retention rates
timeFrame: at week 54 and 108
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: