https://doi.org/10.1016/j.apsb.2025.11.025
This new article publication from Acta Pharmaceutica Sinica B , discusses therapeutic drug monitoring of biologics in inflammatory bowel disease.
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. Five clinical questions were proposed 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 the authors 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.
Keywords: Therapeutic drug monitoring, Biologics, Inflammatory bowel disease, Multidisciplinary guideline
Graphical Abstract: available https://ars.els-cdn.com/content/image/1-s2.0-S2211383525007749-ga1_lrg.jpg
This is the first evidence-based clinical practice guideline on therapeutic drug monitoring in patients with inflammatory bowel disease developed using the GRADE approach.
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The Journal of the Institute of Materia Medica, the Chinese Academy of Medical Sciences and the Chinese Pharmaceutical Association .
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CiteScore: 24.3
Impact Factor: 14.6 (Top 6 journal in the category of Pharmacology and pharmacy)
JIF without self-citation: 13.8
ISSN 2211-3835
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Chen Shi, Hong Zhou, Liangru Zhu, Liyan Miao, Hong Yang, Kaichun Wu, Bikui Zhang, Jinhan He, Mengli Chen, Qian Cao, Jie Liang, Ren Mao, Xiao Chen, Rongsheng Zhao, Bo Zhang, Houwen Lin, Jingwen Wang, Xiaoyang Lu, Jun Xia, Xiaomei Yao, Rong Lin, Minhu Chen, Yu Zhang, Therapeutic drug monitoring of biologics in inflammatory bowel disease: An evidence-based multidisciplinary guideline, Acta Pharmaceutica Sinica B, Volume 16, Issue 1, 2026, Pages 616-641, ISSN 2211-3835, https://doi.org/10.1016/j.apsb.2025.11.025