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Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Gastroenterol. May 21, 2026; 32(19): 117160
Published online May 21, 2026. doi: 10.3748/wjg.v32.i19.117160
Letter to the Editor: Missing mechanistic data and small inflammatory bowel disease cohorts: Key barriers in ustekinumab switching
Qin-Jian Wang, Zheng Zhu, Guang-Rong Lu
Qin-Jian Wang, Guang-Rong Lu, Department of Gastroenterology, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou 325000, Zhejiang Province, China
Zheng Zhu, The Second School of Medicine, Wenzhou Medical University, Wenzhou 325000, Zhejiang Province, China
Co-first authors: Qin-Jian Wang and Zheng Zhu.
Author contributions: Wang QJ and Zhu Z contributed to manuscript writing and editing as co-first authors; Lu GR contributed to conceptualization and critical revisions; all authors have read and approved the final manuscript.
AI contribution statement: During the process of writing the manuscript, I only used translation tools like DeepL and did not use AI tools such as ChatGPT. The main body of the paper has not been generated using AI tools. Only DeepL was used to translate and polish some sentences, without using AI tools to analyze data or assist in manuscript writing. AI tools were not involved in the design of the research or the interpretation of the results.
Supported by Wenzhou Science and Technology Bureau, No. Y20240207.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
Corresponding author: Guang-Rong Lu, Deputy Chief Physician, Department of Gastroenterology, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, No. 109 Xueyuan Western Road, Wenzhou 325000, Zhejiang Province, China. 290636246@qq.com
Received: December 1, 2025
Revised: January 24, 2026
Accepted: February 12, 2026
Published online: May 21, 2026
Processing time: 169 Days and 18.8 Hours
Abstract

This comment discusses the real-world study by Kritzinger et al, published in the recent issue of the World Journal of Gastroenterology, which reports preserved short-term clinical efficacy, stable biomarkers, and high treatment persistence after a mandatory non-medical switch from originator ustekinumab to a biosimilar in inflammatory bowel disease. While acknowledging the novelty and clinical relevance of these findings, the letter highlights two key limitations that constrain their applicability to challenging bedside scenarios. First, outcomes are largely based on symptom scores and routine biomarkers, with limited systematic assessment of endoscopic or radiologic targets, making alignment with current treat-to-target strategies uncertain. Second, the cohort predominantly comprises long-standing, clinically stable ustekinumab responders, limiting extrapolation to high-risk patients with active or only partial disease control at the time of switching. Additionally, the comment addresses the economic drivers of biosimilar policies, potential nocebo effects in mandatory switching scenarios, and the importance of shared decision-making for vulnerable patients.

Keywords: Inflammatory bowel disease; Ustekinumab; Biosimilar switching; Therapeutic drug monitoring; Treat-to-target strategy; Nocebo effect; Shared decision-making

Core Tip: Kritzinger et al report high treatment persistence and stable clinical outcomes after non-medical switching from originator ustekinumab to its biosimilar in inflammatory bowel disease. While reassuring, the findings derive from a cohort of long-term, stable responders and lack systematic evaluation of objective endpoints such as endoscopic healing. These limitations restrict generalizability to higher-risk patients – those with active or partially controlled disease – at the time of switch. Future studies must incorporate treat-to-target endpoints and focus on vulnerable subgroups to guide individualized biosimilar conversion strategies in real-world practice.

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