A Retrospective Analysis on the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Patients With Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Drug retention rates analyzed at weeks 54 of vedolizumab treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with moderate to severe ulcerative colitis
- •Receiving treatment with vedolizumab
排除标准
- •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.
结局指标
主要结局
Drug retention rates analyzed at weeks 54 of vedolizumab treatment
时间窗: at week 54
the drug retention rate of vedolizumab
Drug retention rates analyzed at weeks 108 of vedolizumab treatment
时间窗: at week 108
the drug retention rate of vedolizumab
次要结局
- 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)