Proactive Drug Monitoring versus Clinically-based Dosing for Endoscopic Healing in Pediatric Crohn's Disease Receiving Infliximab.

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology Pub Date : 2025-05-14 DOI:10.1016/j.cgh.2025.04.025

Ben Kang, Eun Sil Kim, Sujin Choi, Byung-Ho Choe, Jin Soo Moon, Jae Sung Ko, Sangjun Sohn, Yeoun Joo Lee, Yiyoung Kwon, Mi Jin Kim, Tae Yeon Jeon, So Mi Lee, Seunghyun Lee, Youngcheol Ju, Yon Ho Choe

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引用次数: 0

Abstract

Background & aims: Proactive dosing based on therapeutic drug monitoring (TDM) of adalimumab is associated with higher rates of sustained corticosteroid-free clinical remission (SCFCR) in children with Crohn's disease (CD) than that with reactive TDM. We aimed to investigate whether proactive dosing of infliximab (IFX) based on TDM is associated with higher rates of endoscopic healing (EH) in pediatric patients with CD than that with clinically-based dosing.

Methods: We conducted a non-blinded, randomized controlled trial of 112 biologic-naïve children with CD who had responded to IFX induction treatment at four centers in South Korea between July 2017 and November 2020. Patients were randomly assigned to receive dosing based on proactive TDM (proactive arm) or clinically-based dosing (clinical arm). The primary endpoint was EH at week 54.

Results: The primary endpoint was achieved in 80.0% (40/50) of the proactive arm and 57.1% (28/49) of the clinical arm (P=.025). SCFCR was achieved in 69.6% (39/56) of the clinical arm and 89.3% (50/56) of the proactive arm at week 54 of treatment (P=.019). According to the multivariate logistic regression analysis, the intervention group (proactive arm vs. clinical arm) was an independent factor associated with EH (odds ratio [OR], 3.48; 95% confidence interval [CI], 1.26-10.43; P=.019) and SCFCR (OR, 5.50; 95% CI, 1.72-21.61; P=.007).

Conclusions: Dosing based on proactive TDM was superior to clinically-based dosing in terms of EH in a randomized controlled trial of pediatric CD.

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接受英夫利昔单抗的儿童克罗恩病内窥镜治疗的主动药物监测与基于临床的剂量

背景与目的：与反应性TDM相比，基于治疗性药物监测（TDM）的阿达木单抗主动给药与克罗恩病（CD）患儿持续无皮质激素临床缓解（SCFCR）的发生率相关。我们的目的是调查基于TDM的主动给药英夫利昔单抗（IFX）是否与儿童CD患者的内镜下愈合率（EH）相关。方法：我们在2017年7月至2020年11月期间在韩国四个中心对IFX诱导治疗有反应的112名患有CD的biologic-naïve儿童进行了一项非盲、随机对照试验。患者被随机分配接受基于主动TDM（主动组）或基于临床给药（临床组）的给药。主要终点是第54周的EH。结果：80.0%（40/50）的主动治疗组和57.1%（28/49）的临床治疗组达到了主要终点（P= 0.025）。在治疗第54周时，69.6%（39/56）的临床组达到了SCFCR， 89.3%（50/56）的主动组达到了SCFCR （P= 0.019）。根据多因素logistic回归分析，干预组（主动组与临床组）是与EH相关的独立因素(优势比[OR]， 3.48；95%置信区间[CI]， 1.26-10.43；P= 0.019)和SCFCR (OR, 5.50；95% ci, 1.72-21.61；P = .007)。结论：在一项儿童CD的随机对照试验中，基于主动TDM的剂量优于基于临床的剂量。

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

Clinical Gastroenterology and Hepatology 医学-胃肠肝病学

CiteScore

16.90

自引率

4.80%

发文量

903

审稿时长

22 days

期刊介绍： Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion. As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.