Publication Name	World Journal of Gastroenterology
Manuscript ID	120684
Country	China

Category	Gastroenterology & Hepatology
Manuscript Type	Opinion Review
Article Title	Extending the evidence on ustekinumab safety in Crohn’s disease: A pharmacovigilance disproportionality analysis of FAERS data
Manuscript Source	Invited Manuscript
All Author List	Qiu-Han Yao and Wei-Yu Yang
Funding Agency and Grant Number
Corresponding Author	Wei-Yu Yang, Assistant Professor, MD, PhD, 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
Key Words	Crohn’s disease; Ustekinumab; Safety; Pharmacovigilance; Adverse event
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.
Citation	Yao QH, Yang WY. Extending the evidence on ustekinumab safety in Crohn’s disease: A pharmacovigilance disproportionality analysis of FAERS data. World J Gastroenterol 2026; In press

Received	2026-03-05 02:14
Peer-Review Started	2026-03-05 02:14
First Decision by Editorial Office Director	2026-03-20 11:34
Return for Revision	2026-03-20 11:34
Revised	2026-04-02 23:15
Publication Fee Transferred
Second Decision by Editor	2026-04-20 02:56
Second Decision by Editor-in-Chief
Final Decision by Editorial Office Director	2026-04-20 07:47
Articles in Press	2026-04-20 07:47
Edit the Manuscript by Language Editor
Typeset the Manuscript

ISSN	1007-9327 (print) and 2219-2840 (online)
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Copyright	©Author(s) (or their employer(s)) 2026. No commercial re-use. See Permissions. Published by Baishideng Publishing Group Inc.
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