Therapeutic drug monitoring of biologics in inflammatory bowel disease: An evidence-based multidisciplinary guideline

Therapeutic drug monitoring (TDM) has emerged as a valuable tool for optimizing the use of biologics in inflammatory bowel disease (IBD). However, variations in focus, methodology, and recommendations among relevant guidelines and consensuses have contributed to inconsistencies in their quality. This guideline synthesizes current evidence to standardize TDM of biologics in IBD, and improve patient outcomes. This multidisciplinary guideline was developed in collaboration with pharmacy, gastroenterology, and pharmacology associations in China. The guideline development group included 9 experts in clinical pharmacy, 4 experts in TDM, 8 gastroenterologists, and 2 methodologists. A comprehensive search was conducted across PubMed, Embase, Web of Science, the Cochrane Library databases, as well as key gastroenterology-relevant guideline websites. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was utilized, and this guideline was registered on the Guideline International Network website. Internal and external reviews were conducted. We proposed 5 clinical questions under two overarching themes. Based on the current evidence and the clinical opinions of the core working group members, the initial recommendations were made. Following comprehensive internal and external review processes, 14 recommendations (1 strong and 13 weak) were finalized for the clinical questions. To our knowledge, this is the first evidence-based clinical practice guideline on TDM in patients with IBD developed using the GRADE approach. It addresses five key questions: whether TDM leads to better therapeutic outcomes than conventional treatment, what indicators should be monitored, when TDM should be initiated, what the therapeutic drug trough concentration thresholds are, and which TDM method (proactive or reactive) can better improve therapeutic outcomes.

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Publication Details

Journal
Acta Pharmaceutica Sinica B
Published
2025-11-27
DOI
https://doi.org/10.1016/j.apsb.2025.11.025
Primary Topic
Inflammatory Bowel Disease
Type
article
Field-Weighted Citation Impact
0.00
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article

Therapeutic drug monitoring of biologics in inflammatory bowel disease: An evidence-based multidisciplinary guideline

Jie Liang, Xiaoyang Lu, Rong Lin, Liangru Zhu et al.
Acta Pharmaceutica Sinica B
Inflammatory Bowel Disease
article

Therapeutic drug monitoring of biologics in inflammatory bowel disease: An evidence-based multidisciplinary guideline

Jie Liang, Xiaoyang Lu, Rong Lin, Liangru Zhu, Xiaomei Yao, Jinhan He, Hou‐Wen Lin, Kaichun Wu, Ye‐Bo Zhou, Rongsheng Zhao, Liyan Miao, Shi Chen, Bikui Zhang, Jun Xia, Yu Zhang, Hong Yang, Bo Zhang, Xiao Chen, Jingwen Wang, Mengli Chen, Minhu Chen, Qian Cao, Ren Mao
article en

Abstract

Therapeutic drug monitoring (TDM) has emerged as a valuable tool for optimizing the use of biologics in inflammatory bowel disease (IBD). However, variations in focus, methodology, and recommendations among relevant guidelines and consensuses have contributed to inconsistencies in their quality. This guideline synthesizes current evidence to standardize TDM of biologics in IBD, and improve patient outcomes. This multidisciplinary guideline was developed in collaboration with pharmacy, gastroenterology, and pharmacology associations in China. The guideline development group included 9 experts in clinical pharmacy, 4 experts in TDM, 8 gastroenterologists, and 2 methodologists. A comprehensive search was conducted across PubMed, Embase, Web of Science, the Cochrane Library databases, as well as key gastroenterology-relevant guideline websites. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was utilized, and this guideline was registered on the Guideline International Network website. Internal and external reviews were conducted. We proposed 5 clinical questions under two overarching themes. Based on the current evidence and the clinical opinions of the core working group members, the initial recommendations were made. Following comprehensive internal and external review processes, 14 recommendations (1 strong and 13 weak) were finalized for the clinical questions. To our knowledge, this is the first evidence-based clinical practice guideline on TDM in patients with IBD developed using the GRADE approach. It addresses five key questions: whether TDM leads to better therapeutic outcomes than conventional treatment, what indicators should be monitored, when TDM should be initiated, what the therapeutic drug trough concentration thresholds are, and which TDM method (proactive or reactive) can better improve therapeutic outcomes.

Acta Pharmaceutica Sinica BVol. 16(1)
Union Hospital (HK), University of Nottingham Ningbo China (CN), Central South University (CN), Sun Yat-sen University (CN), Shanghai Jiao Tong University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Sichuan University (CN), Peking Union Medical College Hospital (CN), Sir Run Run Shaw Hospital (CN), Chinese PLA General Hospital (CN), Soochow University (CN), National Clinical Research Center for Digestive Diseases (CN), West China Hospital of Sichuan University (CN), People's Liberation Army No. 150 Hospital (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), Peking University Third Hospital (CN), First Affiliated Hospital of Soochow University (CN), Second Xiangya Hospital of Central South University (CN), Xijing Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Huazhong University of Science and Technology (CN), Hubei University (CN), Zhejiang University (CN), McMaster University (CA), Air Force Medical University (CN)
Openalex Percentile: Top 61%
Inflammatory Bowel Disease
DOIOpen Access PDFOpenAlex
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