Extending the evidence on ustekinumab safety in Crohn’s disease: A pharmacovigilance disproportionality analysis of FAERS data

doi:10.3748/wjg.120684

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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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. Aug 7, 2026; 32(29): 120684
Published online Aug 7, 2026. doi: 10.3748/wjg.120684

Extending the evidence on ustekinumab safety in Crohn’s disease: A pharmacovigilance disproportionality analysis of FAERS data

Qiu-Han Yao, Wei-Yu Yang

Qiu-Han Yao, Institute of Open Education, Xiamen City University, Xiamen Open University, Xiamen 361000, Fujian Province, China

Wei-Yu Yang, Department of Thoracic Surgery, Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen 361000, Fujian Province, China

Author contributions: Yao QH wrote the original draft; Yang WY contributed to conceptualization, writing, reviewing and editing; Yao QH and Yang WY participated in drafting the manuscript; all authors have read and approved the final version of the manuscript.

Conflict-of-interest statement: The authors declare that they have no competing interests.

Corresponding author: Wei-Yu Yang, MD, PhD, Assistant Professor, Department of Thoracic Surgery, Zhongshan Hospital of Xiamen University, School of Medicine, Xiamen University, No. 201 Hubin South Road, Siming District, Xiamen 361000, Fujian Province, China. yangweiyu@alu.cau.edu.cn

Received: March 5, 2026
Revised: April 2, 2026
Accepted: April 20, 2026
Published online: August 7, 2026
Processing time: 134 Days and 10.5 Hours

Core Tip

Core Tip: Compared with the small clinical cohort reported earlier, this study provides a broader real-world safety evaluation of ustekinumab in Crohn’s disease using 21441 United States Food and Drug Administration Adverse Event Reporting System reports. Infections were the predominant reported adverse events (AEs), and additional cardiovascular and neuropsychiatric disproportionality signals were detected. Because 28.4% of reported AEs occurred within 60 days and nearly half after 180 days, both early and extended monitoring are important. These findings offer practical guidance for individualized safety surveillance during ustekinumab treatment.