Meta-Analysis
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Feb 27, 2024; 16(2): 571-584
Published online Feb 27, 2024. doi: 10.4240/wjgs.v16.i2.571
Is tumor necrosis factor-α monoclonal therapy with proactive therapeutic drug monitoring optimized for inflammatory bowel disease? Network meta-analysis
Fang-Yuan Zheng, Kai-Si Yang, Wen-Cheng Min, Xin-Zhu Li, Yu Xing, Shuai Wang, Ying-Shi Zhang, Qing-Chun Zhao
Fang-Yuan Zheng, Kai-Si Yang, Wen-Cheng Min, Xin-Zhu Li, Yu Xing, Shuai Wang, Ying-Shi Zhang, Qing-Chun Zhao, Teaching Hospital of Shenyang Pharmaceutical University, General Hospital of Northern Theater Command, Shenyang 110016, Liaoning Province, China
Co-first authors: Fang-Yuan Zheng and Kai-Si Yang.
Co-corresponding authors: Ying-Shi Zhang and Qing-Chun Zhao.
Author contributions: Zheng FY, Yang KS, Min WC, Li XZ, Xing Y, Zhang YS, and Zhao QC contributed to the conception and design of the study; Zheng FY, Yang KS, and Zhang YS contributed to the literature search and data extraction; Yang KS, Li XZ, and Xing Y contributed to risk of bias evaluation; Zheng FY, Yang KS, Zhang YS, and Zhao QC contributed to data analysis and interpretation; Zheng FY, Yang KS, Li XZ, Xing Y, Zhang YS, and Zhao QC wrote the first draft of the manuscript and edited the manuscript; all authors contributed to critical revision of the manuscript and approved the manuscript. As the co-first authors, Zheng FY and Yang KS have had the privilege of actively participating in every stage of the research process. From the initial conceptualization of the study to the finalization of the manuscript, Zheng FY and Yang KS have collaborated closely with fellow co-authors, exchanging ideas, refining methodologies, and interpreting results. Our collective efforts have resulted in a comprehensive and robust study, supported by a substantial body of evidence. Zheng FY and Yang KS have carefully analyzed the data, ensuring statistical rigor and validity. Furthermore, Zheng FY and Yang KS have critically evaluated the existing literature, drawing upon relevant studies to provide a solid foundation for the research. Zhang YS and Zhao QC as the co-corresponding authors of this article, expressed utmost support for the research presented in this study. Zhang YS and Zhao QC believe that the findings of this research will significantly contribute to the existing body of knowledge in our field. Furthermore, Zhang YS and Zhao QC have worked closely with a diverse team of experts from different institutions, disciplines, and backgrounds.
Supported by National College Students Innovation and Entrepreneurship Training Program of Shenyang Pharmaceutical University, No. 202210163003.
Conflict-of-interest statement: The authors deny any conflict of interest for this article.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2020 Checklist, and the manuscript was prepared and revised according to the PRISMA 2020 Checklist.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Qing-Chun Zhao, Professor, Teacher, Teaching Hospital of Shenyang Pharmaceutical University, General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang 110016, Liaoning Province, China. zhaoqingchun1967@163.com
Received: October 29, 2023
Peer-review started: October 29, 2023
First decision: December 6, 2023
Revised: December 14, 2023
Accepted: January 16, 2024
Article in press: January 16, 2024
Published online: February 27, 2024
Processing time: 119 Days and 1.1 Hours
Abstract
BACKGROUND

The efficacy and safety of anti-tumor necrosis factor-α (TNF-α) monoclonal antibody therapy [adalimumab (ADA) and infliximab (IFX)] with therapeutic drug monitoring (TDM), which has been proposed for inflammatory bowel disease (IBD) patients, are still controversial.

AIM

To determine the efficacy and safety of anti-TNF-α monoclonal antibody therapy with proactive TDM in patients with IBD and to determine which subtype of IBD patients is most suitable for proactive TDM interventions.

METHODS

As of July 2023, we searched for randomized controlled trials (RCTs) and observational studies in PubMed, Embase, and the Cochrane Library to compare anti-TNF-α monoclonal antibody therapy with proactive TDM with therapy with reactive TDM or empiric therapy. Pairwise and network meta-analyses were used to determine the IBD patient subtype that achieved clinical remission and to determine the need for surgery.

RESULTS

This systematic review and meta-analysis yielded 13 studies after exclusion, and the baseline indicators were balanced. We found a significant increase in the number of patients who achieved clinical remission in the ADA [odds ratio (OR) = 1.416, 95% confidence interval (CI): 1.196-1.676] and RCT (OR = 1.393, 95%CI: 1.182-1.641) subgroups and a significant decrease in the number of patients who needed surgery in the proactive vs reactive (OR = 0.237, 95%CI: 0.101-0.558) and IFX + ADA (OR = 0.137, 95%CI: 0.032-0.588) subgroups, and the overall risk of adverse events was reduced (OR = 0.579, 95%CI: 0.391-0.858) according to the pairwise meta-analysis. Moreover, the network meta-analysis results suggested that patients with IBD treated with ADA (OR = 1.39, 95%CI: 1.19-1.63) were more likely to undergo TDM, especially in comparison with patients with reactive TDM (OR = 1.38, 95%CI: 1.07-1.77).

CONCLUSION

Proactive TDM is more suitable for IBD patients treated with ADA and has obvious advantages over reactive TDM. We recommend proactive TDM in IBD patients who are treated with ADA.

Keywords: Inflammatory bowel disease; Therapeutic drug monitoring; Adalimumab; Infliximab; Network meta-analysis

Core Tip: The efficacy and safety of anti-tumor necrosis factor-α monoclonal antibody therapy [adalimumab (ADA) and infliximab] with therapeutic drug monitoring (TDM), which has been proposed for inflammatory bowel disease (IBD) patients, are still controversial. In this study, we found that proactive TDM was more suitable for IBD patients treated with ADA and had obvious advantages over reactive TDM.