Safety signals of tocilizumab in pediatric patients: A real-world pharmacovigilance analysis based on the FAERS database with network pharmacology insights.
4 affiliations
- 1Department of Pediatrics, Yancheng Maternal and Child Health Care Hospital Affiliated to Yangzhou University, Yancheng, China.
- 2Department of Dermatology, Yancheng Maternal and Child Health Care Hospital Affiliated to Yangzhou University, Yancheng, China.
- 3Department of General Surgery, Yancheng First Hospital, Affiliated Hospital of Nanjing University Medical School, Yancheng, China.
- 4Pediatric Intensive Care Unit, Yancheng First Hospital, Affiliated Hospital of Nanjing University Medical School, Yancheng, China.
Abstract
Tocilizumab, a humanized monoclonal antibody targeting the interleukin-6 receptor, is widely used in immune-mediated diseases, yet its real-world safety in pediatric populations remains insufficiently characterized. This retrospective pharmacovigilance study analyzed adverse event (AE) reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database (2010-2025), focusing on pediatric cases where tocilizumab was the primary suspect drug. After data cleaning, 1,485 reports were included. Four classical disproportionality methods - reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multiple gamma Poisson shrinker (MGPS) - were used to identify safety signals. Time-to-onset, stratified, and Weibull analyses were applied to characterize adverse event patterns, and network pharmacology was used to explore potential underlying mechanisms. Females accounted for 58.9% of reports, and adolescents aged 12-17 years represented the largest group. A total of 109 safety signals were identified. The most frequently reported AEs included juvenile idiopathic arthritis (ROR = 28.62, 95% CI: 24.30-33.72), haemophagocytic lymphohistiocytosis (ROR = 15.83, 95% CI: 13.18-19.02), and decreased white blood cell count (ROR = 12.14, 95% CI: 9.90-14.88). Potential unlisted AEs, such as sudden hearing loss (ROR = 48.11, 95% CI: 16.74-138.26) and psoriasis (ROR = 11.44, 95% CI: 8.81-14.85), were also detected. Most AEs occurred within 30 days, with a median onset of 14 days, and showed an early failure pattern. Network pharmacology suggested psoriasis may involve JAK-STAT and Th17/Th1 pathways, though further validation is needed. Overall, this study provides real-world evidence to support improved safety monitoring in pediatric patients.
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BibTeX
@article{wu2026safety,
title = {{Safety signals of tocilizumab in pediatric patients: A real-world pharmacovigilance analysis based on the FAERS database with network pharmacology insights.}},
author = {Gang Wu and Xueqing Ma and Bin Zhu and Ben Liu},
journal = {Human vaccines \& immunotherapeutics},
year = {2026},
month = oct,
doi = {10.1080/21645515.2026.2744469},
url = {https://europepmc.org/article/MED/42873988},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Safety signals of tocilizumab in pediatric patients: A real-world pharmacovigilance analysis based on the FAERS database with network pharmacology insights.
AU - Gang Wu
AU - Xueqing Ma
AU - Bin Zhu
AU - Ben Liu
PY - 2026
DA - 2026/10/14
JO - Human vaccines & immunotherapeutics
DO - 10.1080/21645515.2026.2744469
UR - https://europepmc.org/article/MED/42873988
AB - Tocilizumab, a humanized monoclonal antibody targeting the interleukin-6 receptor, is widely used in immune-mediated diseases, yet its real-world safety in pediatric populations remains insufficiently characterized. This retrospective pharmacovigilance study analyzed adverse event (AE) reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database (2010-2025), focusing on pediatric cases where tocilizumab was the primary suspect drug. After data cleaning, 1,485 reports were included. Four classical disproportionality methods - reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multiple gamma Poisson shrinker (MGPS) - were used to identify safety signals. Time-to-onset, stratified, and Weibull analyses were applied to characterize adverse event patterns, and network pharmacology was used to explore potential underlying mechanisms. Females accounted for 58.9% of reports, and adolescents aged 12-17 years represented the largest group. A total of 109 safety signals were identified. The most frequently reported AEs included juvenile idiopathic arthritis (ROR = 28.62, 95% CI: 24.30-33.72), haemophagocytic lymphohistiocytosis (ROR = 15.83, 95% CI: 13.18-19.02), and decreased white blood cell count (ROR = 12.14, 95% CI: 9.90-14.88). Potential unlisted AEs, such as sudden hearing loss (ROR = 48.11, 95% CI: 16.74-138.26) and psoriasis (ROR = 11.44, 95% CI: 8.81-14.85), were also detected. Most AEs occurred within 30 days, with a median onset of 14 days, and showed an early failure pattern. Network pharmacology suggested psoriasis may involve JAK-STAT and Th17/Th1 pathways, though further validation is needed. Overall, this study provides real-world evidence to support improved safety monitoring in pediatric patients.
SN - 2164-5515
SN - 2164-554X
ER -