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; 32(29): 120684 [DOI: 10.3748/wjg.120684]
Corresponding Author of This Article
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
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Gastroenterology & Hepatology
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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; 32(29): 120684 [DOI: 10.3748/wjg.120684]
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 10.6 Hours
Abstract
A previous retrospective study reported that most postoperative Crohn’s disease (CD) patients achieved clinical remission after ustekinumab therapy, with few adverse events (AEs) observed. While their findings were clinically significant, some limitations warrant consideration. First, the authors acknowledged that the small cohort size (n = 71) may limit the reliability. Second, their study examined only a narrow spectrum of AEs. Third, their analysis presented only AE incidence counts without assessing crucial safety parameters, including temporal patterns, strength characteristics, or clinical risk mitigation strategies. To address these limitations, we conducted a pharmacovigilance analysis using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database from 2004 (Q1) to 2025 (Q2). Disproportionality analyses were performed using the reporting odds ratio (ROR) and proportional reporting ratio to characterize ustekinumab-associated AEs in CD. A total of 21441 AE reports were identified. Our results indicated that infections remain the predominant AE category reported with ustekinumab [lower respiratory tract infection (ROR = 7.26, 95%CI: 6.7-7.87), clostridium difficile infection (ROR = 3, 95%CI: 2.71-3.31), and abscess (ROR = 2.01, 95%CI: 1.82-2.21)], consistent with its established safety profile. In addition, several cardiovascular and neuropsychiatric disproportionality signals were detected, including left ventricular dysfunction, dilated cardiomyopathy, acute coronary syndrome, pulseless electrical activity, suicide, abnormal dreams, obsessive-compulsive disorder, and autoscopy. Early monitoring within the first two months and continued surveillance beyond six months may be warranted, particularly in high-risk populations. These findings complement and extend those of previous study. However, FAERS has some limitations, including underreporting, reporting bias, and the inability to determine causality; therefore, these findings require confirmation in further studies.
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.
