Annual Therapeutic Drug Monitoring in Patients with Inflammatory Bowel Disease During Infliximab Maintenance Therapy: Balancing Efficacy with Risk of Pharmacokinetic Failure.

IF 2.5 4区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Digestive Diseases and Sciences Pub Date : 2025-04-29 DOI:10.1007/s10620-025-09032-9

Yujin Lim, Boram Park, Kyeongman Jeon, Ok Soon Jeong, Eun Ran Kim, Young-Ho Kim, Dong Kyung Chang, Sung Noh Hong

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引用次数: 0

Abstract

Background and aims: Recent studies indicate that proactive therapeutic drug monitoring (TDM) can improve clinical outcomes in patients with inflammatory bowel disease (IBD) treated with infliximab. Repetitive infliximab trough level (IFX TL) measurements for proactive TDM may increase patient inconvenience and medical costs. Therefore, we aimed to determine the optimal interval for TDM during infliximab maintenance therapy in patients with IBD.

Methods: A prospective cohort study was performed on the patients with IBD who were in clinical remission on infliximab maintenance therapy and had IFX TL ≥ 3 μg/mL after one-time dose optimization. Infliximab TL were measured before each infliximab infusion to identify the pharmacokinetic (PK) relapse (two consecutive IFX TL < 3 μg/mL). Kaplan-Meier method was used to calculate the time to PK relapse.

Results: A total of 103 patients were enrolled and followed for a median of 18.5 months. PK relapse occurred in 19 patients (18.5%), with a higher rate of PK relapse in patients with IFX TL 3-5 μg/mL (16/60, 26.7%) compared to those with IFX TL ≥ 5 μg/mL (3/43, 7.0%). Kaplan-Meier survival time to maintain 95%, 90%, 85%, 80%, and 75% therapeutic IFX TL persistence rate without PK relapse was 4.1, 10.3, 13.3, 14.3, and 19.8 months, respectively. Log-rank test showed that therapeutic IFX TL persistence rates were significantly lower in patients with IFX TL 3-5 μg/mL group compared to those with IFX TL ≥ 5 μg/mL group (p = 0.010). Kaplan-Meier retention time to maintain 85% therapeutic IFX TL persistence rate without PK relapse was 10.3 months in IFX TL 3-5 μg/mL group and 20.2 months in IFX TL ≥ 5 μg/mL group, respectively.

Conclusions: Proactive TDM measuring with IFX TL annually may be helpful in maintaining therapeutic IFX TL ≥ 3 μg/mL in 85% of patients with IBD and clinical remission on infliximab maintenance therapy.

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炎症性肠病患者在英夫利昔单抗维持治疗期间的年度治疗药物监测：平衡疗效与药代动力学失效的风险

背景和目的：最近的研究表明，主动治疗性药物监测（TDM）可以改善炎症性肠病（IBD）患者使用英夫利昔单抗治疗的临床结果。反复测量英夫利昔单抗槽水平（IFX TL）可能会增加患者的不便和医疗费用。因此，我们旨在确定IBD患者在英夫利昔单抗维持治疗期间TDM的最佳间隔时间。方法：前瞻性队列研究采用英夫利昔单抗维持治疗临床缓解且经一次剂量优化后IFX TL≥3 μg/mL的IBD患者。每次输注英夫利昔单抗前测量英夫利昔单抗TL，以确定药代动力学（PK）复发（连续两次IFX TL）。结果：共纳入103例患者，随访时间中位数为18.5个月。19例患者出现PK复发率（18.5%），其中IFX TL 3-5 μg/mL组PK复发率（16/60,26.7%）高于IFX TL≥5 μg/mL组（3/43,7.0%）。Kaplan-Meier生存期维持95%、90%、85%、80%和75%的治疗性IFX TL持续率且无PK复发分别为4.1、10.3、13.3、14.3和19.8个月。Log-rank检验显示，与IFX TL≥5 μg/mL组相比，IFX TL 3-5 μg/mL组患者治疗性IFX TL持续率显著降低（p = 0.010）。IFX TL 3-5 μg/mL组和IFX TL≥5 μg/mL组的Kaplan-Meier保留时间分别为10.3个月和20.2个月。结论：每年使用IFX TL进行主动TDM测量可能有助于85%的IBD患者维持治疗性IFX TL≥3 μg/mL，并通过英夫利昔单抗维持治疗获得临床缓解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Digestive Diseases and Sciences 医学-胃肠肝病学

CiteScore

6.40

自引率

3.20%

发文量

420

审稿时长

1 months

期刊介绍： Digestive Diseases and Sciences publishes high-quality, peer-reviewed, original papers addressing aspects of basic/translational and clinical research in gastroenterology, hepatology, and related fields. This well-illustrated journal features comprehensive coverage of basic pathophysiology, new technological advances, and clinical breakthroughs; insights from prominent academicians and practitioners concerning new scientific developments and practical medical issues; and discussions focusing on the latest changes in local and worldwide social, economic, and governmental policies that affect the delivery of care within the disciplines of gastroenterology and hepatology.