A Retrospective Analysis on the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Patients With Ulcerative Colitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Drug retention rates analyzed at weeks 54 of vedolizumab treatment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with moderate to severe ulcerative colitis
- •Receiving treatment with vedolizumab
Exclusion Criteria
- •Combination therapy with other biological agents, small molecule drugs, immunosuppressants or hormone therapy.
- •Combination of active tuberculosis, Clostridium difficile infection, cytomegalovirus infection, EBV infection, etc.
- •Combined with malignant tumors or autoimmune diseases (such as dry syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc.).
- •Combined with serious cardiovascular and cerebrovascular diseases or liver and renal insufficiency.
- •Loss of visit or clinical data ≥30% during the follow-up period.
Outcomes
Primary Outcomes
Drug retention rates analyzed at weeks 54 of vedolizumab treatment
Time Frame: at week 54
the drug retention rate of vedolizumab
Drug retention rates analyzed at weeks 108 of vedolizumab treatment
Time Frame: at week 108
the drug retention rate of vedolizumab
Secondary Outcomes
- Analyze the impact of baseline MES on VDZ drug retention rates(at week 54 and 108)
- Analyze the impact of baseline disease sites on VDZ drug retention rates(at week 54 and 108)
- Analyze the impact of baseline modified Mayo score on VDZ drug retention rates(at week 54 and 108)
- Analyze the impact of duration of disease on VDZ drug retention rates(at week 54 and 108)
- Analyze the impact of baseline C-reactive protein in peripheral blood on VDZ drug retention rates(at week 54 and 108)
- Analyze the impact of baseline erythrocyte sedimentation rate on VDZ drug retention rates(at week 54 and 108)
- Analyze the impact of baseline 25(OH) D in peripheral blood on VDZ drug retention rates(at week 54 and 108)
- Analyze the impact of baseline serum albumin in peripheral blood on VDZ drug retention rates(at week 54 and 108)
- Analysis of the impact of baseline absolute eosinophil count in peripheral blood on VDZ drug retention rates(at week 54 and 108)
- Analysis of the impact of baseline hemoglobin in peripheral blood on VDZ drug retention rates(at week 54 and 108)
- Analysis of the impact of baseline white blood cell count in peripheral blood on VDZ drug retention rates(at week 54 and 108)
- Analysis of the impact of baseline platelet count in peripheral blood on VDZ drug retention rates(at week 54 and 108)
- Analysis of the impact of baseline body mass index on VDZ drug retention rates(at week 54 and 108)