关于炎症性肠病（IBD）非抗肿瘤坏死因子治疗的治疗药物监测（TDM）的数据有限。本研究旨在评估主动 TDM 对接受静脉注射 (iv) 维多珠单抗 (VDZ) 治疗的 IBD 患者的疗效。这项单中心回顾性队列研究纳入了 2016 年 11 月至 2023 年 3 月期间接受静脉注射 VDZ 维持治疗并接受 TDM 的连续 IBD 患者。患者被随访至 2023 年 6 月，并被分为 2 组：至少接受过 1 次主动 TDM 的患者与仅接受反应性 TDM 的患者。进行生存分析以评估药物持久性，定义为无需因反应丧失、严重不良事件或 IBD 相关手术而停药。研究人群包括 94 名患者（主动 TDM，n = 72）， IBD（溃疡性结肠炎，n = 53）。与仅接受反应性 TDM 的患者相比，接受至少 1 次主动 TDM 的患者表现出更高的药物持续累积概率 (Log-rank P < .001)。在多变量 Cox 比例风险回归分析中，至少 1 个主动 TDM 是与药物持久性相关的唯一因素（风险比，14.3；95% 置信区间 [CI]，3.8-50；P < .001）。 ROC 分析确定 12.5 µg/mL 的 VDZ 浓度是与药物持久性相关的最佳药物浓度阈值（ROC 曲线下面积：0.691；95% CI，0.517-0.865；P = 0.049）。在此单中心反映现实临床实践的回顾性研究表明，主动 TDM 与接受静脉注射 VDZ 治疗的 IBD 患者的药物持久性增加相关。© 作者 2024。由牛津大学出版社代表克罗恩病出版

There are limited data regarding therapeutic drug monitoring (TDM) of non-anti-tumor necrosis factor therapy in inflammatory bowel disease (IBD). This study aimed to evaluate the efficacy of proactive TDM in IBD patients treated with intravenous (iv) vedolizumab (VDZ).This single-center retrospective cohort study included consecutive IBD patients treated with maintenance iv VDZ therapy undergoing TDM from November 2016 to March 2023. Patients were followed through June 2023 and were divided in to 2 groups: those who had at least 1 proactive TDM vs those who underwent only reactive TDM. A survival analysis was performed to evaluate drug persistence, defined as no need for drug discontinuation due to loss of response, serious adverse event, or an IBD-related surgery.The study population consisted of 94 patients (proactive TDM, n = 72) with IBD (ulcerative colitis, n = 53). Patients undergoing at least 1 proactive TDM compared with patients having only reactive TDM demonstrated a higher cumulative probability of drug persistence (Log-rank P < .001). In multivariable Cox proportional hazard regression analysis, at least 1 proactive TDM was the only factor associated with drug persistence (hazard ratio, 14.3; 95% confidence interval [CI], 3.8-50; P < .001). A ROC analysis identified a VDZ concentration of 12.5 µg/mL as the optimal drug concentration threshold associated with drug persistence (area under the ROC curve: 0.691; 95% CI, 0.517-0.865; P = .049).In this single-center retrospective study reflecting real-life clinical practice, proactive TDM was associated with increased drug persistence in patients with IBD treated with iv VDZ.© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.