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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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]
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
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.
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; 32(29): 120684
The article by Ma et al[1] evaluated ustekinumab in postoperative Crohn’s disease (CD). The authors reported that the majority of patients (81.7%) achieved endoscopic improvement after ustekinumab therapy, and that only few adverse events (AEs) were observed (n = 7). Their study provides useful real-world clinical evidence, particularly because the multicenter design enhances the relevance of the findings to routine practice.
The clinical use of ustekinumab in CD has received increasing attention[2-4]. A multicenter study conducted in Spain enrolled patients with active CD who had received ustekinumab for at least 6 months. The results suggested that ustekinumab was effective in the treatment of CD, including in patients with refractory disease[5]. Another Dutch study involving 252 patients with CD found that approximately one-third achieved corticosteroid-free clinical remission after 104 weeks of ustekinumab treatment[6].
While the findings of Ma et al[1] are clinically important, some limitations merit further consideration. First, as the authors noted, the relatively small cohort (n = 71) may limit the reliability of the findings. Second, the study assessed only a narrow spectrum of AEs, including upper respiratory infection, renal impairment, liver function abnormality, and hand numbness. The study omitted other clinically significant ustekinumab-associated AEs, such as abscess[7,8], allergic reactions[9,10], neurologic disorders[11,12], although such AEs may influence treatment decisions, require hospitalization, or necessitate drug discontinuation. Third, their study merely reported incidence counts without evaluating key safety dimensions, including time to onset, signal strength, or providing concrete guidance for clinical risk mitigation. Therefore, to address these limitations, we conducted a pharmacovigilance analysis to characterize AEs associated with ustekinumab in patients with CD.
The United States Food and Drug Administration Adverse Event Reporting System (FAERS) provides a useful complementary data source for post-marketing safety evaluation[13]. Although FAERS cannot establish causality, it enables large-scale signal detection across broad AE categories and can help identify uncommon, delayed, or unexpectedly reported events that may not be captured in smaller clinical cohorts. To date, large-scale studies specifically characterizing ustekinumab-associated safety signals in patients with CD remain limited.
Therefore, this study aimed to characterize the AE profile of ustekinumab in CD using FAERS, with a focus on disproportionality signals, time-to-onset patterns, and clinically relevant implications for safety monitoring.
BIBLIOGRAPHIC RETRIEVAL
This study was a retrospective pharmacovigilance analysis based on the FAERS, a spontaneous reporting database used for post-marketing drug safety surveillance. We extracted AE reports from FAERS covering the period from 2004 Q1 to 2025 Q2. This time window was selected to ensure complete retrieval from the full available FAERS dataset and consistent data processing across reporting periods. Querying the entire database minimized the risk of incomplete capture of eligible ustekinumab-associated reports in CD. Only reports in which ustekinumab was designated as the primary suspect drug were included to improve specificity. Concomitant medications were not excluded from the dataset; however, because FAERS lacks sufficient clinical granularity for reliable causal adjustment, no formal adjustment for concomitant drug exposure was performed. Therefore, the observed safety signals should be interpreted as reporting associations rather than drug-specific causal effects. To improve specificity, only reports in which the indication was CD were included in the analysis. Duplicate reports were removed according to the United States Food and Drug Administration-recommended deduplication strategy[14]. When multiple records shared the same CASEID, the report with the most recent FDAISR and case version was retained. Demographic and clinical variables, including sex, age, reporter type, reporting country, serious outcomes, preferred terms (PTs), therapy start date, and event date, were extracted for descriptive analyses.
To detect AE signals, we conducted disproportionality analyses using the reporting odds ratio (ROR) and proportional reporting ratio (PRR). Disproportionality analysis is a widely used method in pharmacovigilance research[15]. The ROR estimates the relative odds of reporting a specific AE with ustekinumab compared with that for all other drugs in the database[16]. The PRR is calculated by dividing the proportion of AE reports attributed to ustekinumab by the corresponding proportion for other drugs[17]. Positive signals were defined according to conventional pharmacovigilance criteria: For the ROR, the lower limit of the 95%CI exceeding 1; and for the PRR, a PRR ≥ 2, a χ2 value ≥ 4, and at least three reported cases. These thresholds were selected because they are established signal detection criteria intended for exploratory pharmacovigilance screening. From a pharmacovigilance perspective, a higher ROR or PRR suggests that a specific AE is reported more frequently with ustekinumab than expected relative to the background reporting pattern in FAERS. All detected signals should be interpreted cautiously and regarded as hypothesis-generating.
Time to onset was calculated in days as the interval between the recorded therapy start date and the AE onset date[18]. Only reports with complete and internally consistent date information were included in the time-to-onset analysis, whereas reports with missing, implausible, or contradictory dates were excluded from this analysis. Missing data were not imputed; instead, analyses were conducted based on the available data for each variable. In addition, extreme values deemed implausible and likely to result from recording errors were removed during data cleaning. Because FAERS is a spontaneous reporting system, this study was intended for signal detection and hypothesis generation rather than the estimation of incidence or the assessment of causality[19]. Statistical analyses and data processing were performed using R version 4.3.2[20,21]. The R scripts used for data cleaning, deduplication, disproportionality analysis, and time-to-onset analysis are available from the corresponding author.
Because FAERS is a spontaneous reporting system, it is inherently subject to underreporting, selective reporting, stimulated reporting, duplicate submission, variable report quality, and incomplete clinical information. In addition, important covariates such as disease severity, comorbidities, dose, and concomitant treatments are often unavailable or incompletely recorded. Accordingly, the present analysis was designed for signal detection and hypothesis generation, and should not be used to estimate incidence or establish causality.
MAIN FINDINGS
A comprehensive analysis of ustekinumab-associated AE reports identified 21441 cases during the study period (Table 1). Demographic analyses showed a marked sex imbalance, with females accounting for 56.8% of reports and males 34.8%; the remainder had missing or unreported sex information. Age stratification showed the following distribution among reports with available age data: (1) < 18 years, 2.6%; (2) 18-64 years, 51.1%; (3) 65-85 years, 9.2%; and (4) > 85 years, 0.3%. The 36.8% of reports lacked age information, which may introduce reporting bias and limit the interpretability of age-related patterns. Reporting peaked in 2020, comprising 24.1% of all cases. Reports were submitted primarily by consumers (41.6%), followed by healthcare professionals (25.4%) and physicians (15.3%). The United States contributed the largest share of reports (55.5%). Regarding clinical outcomes, hospitalization was the most common serious outcome (22.2%), and death was reported in 1.4% of cases.
Table 1 Basic characteristics of Crohn’s disease patients with adverse events associated with ustekinumab from the United States Food and Drug Administration Adverse Event Reporting System database, n (%).
The time to onset of ustekinumab-associated AEs was assessed in days to characterize the temporal distribution of reported reactions after treatment initiation (Figure 1). Overall, the distribution suggested a bimodal pattern. 16.0% of AEs occurred within the first 30 days after ustekinumab initiation; thereafter, the reporting frequency declined as treatment duration increased. Specifically, 12.4% of events were reported between 31 days and 60 days, 5.5% between 61 days and 90 days, 6.0% between 91 days and 120 days, 4.0% between 121 days and 150 days, and 4.2% between 151 days and 180 days. Notably, a substantial proportion of events were also reported at later time points, including 18.4% between 181 days and 360 days, 16.6% between 361 days and 720 days, and 16.9% beyond 720 days. This temporal pattern suggests that AE monitoring should not be limited to the initial treatment period alone. Early vigilance may be particularly important for treatment-related reactions and acute infectious complications, whereas extended follow-up may be necessary to detect delayed or cumulative events.
Figure 1
Time to onset analysis of adverse events after treatment with ustekinumab.
Table 2 presents the frequencies of positive signals for the 40 most commonly reported PTs associated with ustekinumab. It should be noted that a statistically detected disproportionality signal does not necessarily imply clinical importance or causality; rather, it indicates that a given event was reported more frequently than expected relative to the overall FAERS background. From a clinical perspective, events that are both commonly reported and biologically plausible may be more relevant for routine safety monitoring than rare signals with extreme disproportionality estimates. To improve interpretability, the reported PTs were further considered within broader clinical categories, including infections, treatment-related or hypersensitivity reactions, cardiovascular events, neuropsychiatric events, and other organ-specific events. Among the most frequently reported PTs, lower respiratory tract infection (n = 909), infusion-related reaction (n = 698), and Clostridioides difficile infection (n = 484) were the three most common, indicating that infectious complications and treatment-related reactions constituted the dominant reported AE profile. These findings are clinically relevant because they are broadly consistent with the established immunomodulatory safety profile of ustekinumab and underscore the importance of infection surveillance during treatment[22-24].
Table 2 Top 40 preferred terms associated with ustekinumab in Crohn’s disease, ranked by reporting frequency.
Table 3 summarizes signal strength for the top 40 PTs, with the strongest signals observed for cavernous sinus thrombosis, rubella, mastocytosis, and vagus nerve disorder. However, several of these findings were based on very small numbers of reports, in some instances no more than five cases, and therefore should be interpreted with particular caution. Importantly, signal strength does not necessarily correspond to clinical frequency; rather, it reflects the degree of disproportionate reporting relative to the overall FAERS database[25,26]. Thus, highly ranked signals may represent rare but notable events that require further confirmation, whereas more frequently reported events may have greater immediate clinical relevance for routine monitoring.
Table 3 Top 40 preferred terms associated with ustekinumab in Crohn’s disease, ranked by signal strength.
Taken together, Tables 2 and 3 illustrate two complementary aspects of the safety profile of ustekinumab. Table 2 reflects the AEs most commonly reported in clinical practice, whereas Table 3 highlights events with disproportionately strong reporting signals compared with the overall reporting background in FAERS. From a clinical perspective, commonly reported infectious events may be more relevant for routine monitoring, whereas strong but rare signals may serve primarily as pharmacovigilance alerts that warrant further investigation rather than being interpreted as evidence of causality[27,28].
DISCUSSION
To complement and extend the recent study by Ma et al[1], we conducted a pharmacovigilance analysis to characterize AEs associated with ustekinumab in patients with CD. Our results provide additional evidence to inform the monitoring and management of ustekinumab in CD. Our pharmacovigilance analysis corroborated the established safety profile of ustekinumab[29,30]. Infections were the most frequently reported AEs, with lower respiratory tract infection, cellulitis, kidney infection, and upper respiratory tract infection among the most commonly reported events. These findings are consistent with current clinical guidelines and the prescribing information for ustekinumab[31,32].
Patients receiving ustekinumab may be at increased risk of infection owing to immunomodulation, consistent with the strong disproportionality signals observed for infectious events. This predisposition may be attributable to the inhibition of the IL-12/23 signaling pathway, which plays a pivotal role in host defense[33,34]. Previous studies comparing biologics with respect to infection risk have suggested that, overall, ustekinumab is associated with the lowest risk in maintenance trials[35]. In addition, a recent retrospective cohort study evaluated the risk of Clostridioides difficile infection among patients with CD treated with ustekinumab compared with anti-tumor necrosis factor (TNF) agents[36]. The study reported no significant increase in risk with ustekinumab relative to anti-TNF therapy. Our current data indicate that certain infectious events were reported disproportionately often in the FAERS database and may warrant continued pharmacovigilance attention.
Our pharmacovigilance study also identified several potentially novel ustekinumab-related AEs, including left ventricular dysfunction, dilated cardiomyopathy, acute coronary syndrome, and pulseless electrical activity, as well as neuropsychiatric events such as suicide, abnormal dreams, obsessive-compulsive disorder, and autoscopy. These observations extend prior evidence and underscore the importance of carefully considering patients’ psychiatric history when initiating ustekinumab[37]. Patients at heightened risk of nonadherence to or discontinuation of biologic therapy may warrant closer surveillance and proactive psychiatric support. These observations may also reflect alternative explanations, including underlying disease burden, comorbid cardiovascular or psychiatric illness, concomitant medications, residual confounding, reporting bias, and incomplete case information. These findings highlight the need for further research to elucidate the underlying mechanisms.
Overall, our pharmacovigilance analysis corroborated the established safety profile of ustekinumab, with infections representing the predominant category of reported AEs. At the same time, several cardiovascular and neuropsychiatric PTs were identified as disproportionality signals in the FAERS database. However, these findings should be interpreted with caution. In particular, some of these signals were based on small numbers of reports and were accompanied by wide confidence intervals, which limited their robustness and clinical interpretability. Therefore, rather than representing conclusive evidence of novel ustekinumab-related adverse reactions, these observations should be regarded as hypothesis-generating safety signals that warrant further evaluation in well-designed pharmacoepidemiological, clinical, and mechanistic studies. From a clinical perspective, these findings suggest that unusual cardiovascular or neuropsychiatric symptoms arising during ustekinumab therapy may warrant attention, particularly in patients with relevant comorbidities; however, a direct causal relationship cannot be established on the basis of spontaneous reporting data alone.
Given these findings, clinicians should remain aware of the possibility of rare but potentially serious AEs during ustekinumab therapy, particularly in patients with underlying cardiovascular disease or psychiatric comorbidities. Rather than implying routine diagnostic requirements, our results support careful clinical monitoring and individualized assessment during treatment. Before initiating therapy, risk stratification may be undertaken through baseline assessments, including appropriate imaging studies[38,39] and standardized psychiatric rating scales[40,41], as part of an individualized risk-benefit evaluation. During treatment, structured monitoring within the first two months is essential, given that 28.4% of AEs occurred within 60 days of exposure. Moreover, continued surveillance beyond six months is warranted, as nearly half of reported AEs arose after 180 days. Symptom checklists[42,43] and targeted laboratory testing[44,45] may facilitate early detection and timely intervention. Regulatory authorities should also consider revising the ustekinumab product labeling to describe potential risks more explicitly.
In general, ustekinumab was found to be well tolerated in most patients[46-48]. A multicenter prospective cohort study conducted in Australia by An et al[49] reported 161 AEs among 197 patients with CD, including 41 hospitalizations; however, only eight patients discontinued treatment because of AEs. Similarly, a study of 2574 patients by Sandborn et al[50] showed that, across a pooled inflammatory bowel disease population, the safety profile of ustekinumab over one year was favorable and generally comparable to placebo.
The identification of additional AEs has important clinical implications. First, it encourages clinicians to consider a potential association with ustekinumab when patients develop compatible symptoms during therapy, thereby supporting more accurate and timely diagnosis. This is particularly pertinent for high-risk individuals, for whom a more rigorous risk-benefit assessment should precede treatment initiation. In addition, patient management may be strengthened by educating patients to recognize and promptly report such events. Collectively, these measures may enable earlier risk detection, more timely intervention, and improved patient safety.
The apparent differences between FAERS-derived signals and findings from randomized controlled trials or prospective cohorts should also be considered. Controlled trials generally include stricter eligibility criteria, protocol-driven follow-up, adjudicated outcome collection, and relatively limited sample sizes for rare events, whereas FAERS captures reports from broader and more heterogeneous populations. As a result, rare, delayed, or unexpected events may be more likely to emerge in spontaneous reporting systems, while controlled studies provide more reliable estimates of comparative risk under defined conditions. The novelty of this study lies in its use of a large FAERS dataset to provide a broader real-world assessment of ustekinumab-associated AEs in CD, identify additional potential cardiovascular and neuropsychiatric safety signals, and characterize temporal patterns through time-to-onset analysis.
Several limitations inherent to FAERS should be acknowledged. First, FAERS is a spontaneous reporting system and is therefore subject to underreporting[51], selective reporting[52], stimulated reporting[53], duplicate submission[54], and variable report quality[55]. Second, important clinical information is often incomplete or unavailable[56,57], including disease severity, comorbidities, concomitant medications, treatment duration, and dose, which may introduce substantial residual confounding. Reporting patterns may also be influenced by time since approval, including possible Weber-effect-type spikes or other temporal fluctuations in reporting intensity. Third, disproportionality analysis reflects reporting patterns rather than true event frequency and therefore cannot be used to estimate incidence or establish causality[58,59]. Fourth, some statistically significant signals may be clinically implausible or reflect data noise, misclassification, confounding by indication, or incomplete case filtering, particularly when based on very small case numbers[60,61]. For this reason, signals involving congenital, neonatal, or other low-plausibility events should be interpreted with particular caution. Finally, because the United States accounted for the largest share of reports in our dataset, geographical reporting bias cannot be excluded. Accordingly, the findings of this study should be considered preliminary and hypothesis-generating, and require confirmation in prospective studies and other real-world data sources.
CONCLUSION
In conclusion, our pharmacovigilance analysis supports the established safety profile of ustekinumab in CD, with infections remaining the predominant reported AEs. At the same time, several additional cardiovascular and neuropsychiatric signals were identified, although these findings should be interpreted cautiously because spontaneous reporting data cannot establish causality. Further prospective studies and other real-world investigations are needed to validate these observations. We acknowledge the valuable contributions of Ma et al[1]. Building on their important contributions, our pharmacovigilance analysis provides additional insight into the clinical application of ustekinumab in CD.
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