Journal Article

Evaluation of the real-world safety of Canakinumab in the treatment of systemic juvenile idiopathic arthritis in children aged 0–16: a comprehensive analysis based on FAERS data

Qi, Yifan, Liu, Jianjia, Xiao, Peng, Wan, Hejia, Huang, Yong, Zhang, Xinyue, Wei, Bingqi, Zhang, Guilong, Chen, Liu

2025

Overview

Background Canakinumab is a fully human monoclonal antibody that primarily targets interleukin-1β (IL-1β) and is primarily indicated for systemic juvenile idiopathic arthritis (sJIA). Since it is predominantly used in children aged 0–16 years, exploring its safety in real-world settings is of paramount importance. Methods This study evaluated the real-world safety of Canakinumab in clinical practice by analyzing adverse events (AEs) associated with the use of the drug in the 0–16 year age group with sJIA from 2014 to 2023, using data retrieved from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis of relevant AEs was performed via four methods: the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the multi-item gamma Poisson shrinker (MGPS), and the Bayesian confidence propagation neural network (BCPNN). Additionally, the Weibull shape parameter (WSP) test distribution was employed to model the risk of AEs over time. Results A total of 439 adverse events (AEs) were included in this study. Positive signals were identified for several adverse reactions listed on the drug label, including inappropriate schedule of product administration, incorrect dose administered, rash, illness, gastroenteritis, thrombocytopenia, lymphadenopathy, leukopenia, transaminases increased, aspartate aminotransferase increased and alanine aminotransferase increased. Furthermore, the study identified potential adverse reactions not mentioned on the label, such as hemophagocytic lymphohistiocytosis, COVID-19, nasal congestion and increased serum ferritin. These findings underscore the importance of AE monitoring, particularly emphasizing the value of early detection. Conclusion This FAERS-based pharmacovigilance study provides preliminary safety data on the use of Canakinumab in children aged 0–16 years with sJIA, confirming several known adverse reactions and revealing additional potential risks. These findings offer clinicians valuable safety information for the use of Canakinumab in the treatment of sJIA.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adverse Drug Reaction Reporting Systems - statistics & numerical data / Age groups / Algorithms / Analysis / Antibodies, Monoclonal, Humanized - adverse effects / Antirheumatic Agents - adverse effects / Arthritis / Arthritis, Juvenile - drug therapy / Bayes Theorem / Canakinumab / Care and treatment / Child / Child, Preschool / Children / Complications and side effects / Comprehensive analysis / Cytokines / Drug-Related Side Effects and Adverse Reactions - epidemiology / Drug-Related Side Effects and Adverse Reactions - etiology / FAERS / FDA approval / Female / Ferritin / Gastroenteritis / Humans / Immune system / Infant / Infant, Newborn / Interleukins / Lymphatic diseases / Lymphatic system / Male / Medicine / Medicine & Public Health / Neural networks / Odds Ratio / Patients / Pediatrics / Pharmacovigilance / Poisoning / Poisson Distribution / Real-world safety / Rheumatology / Safety and security measures / Side effects / Statistical analysis / Systemic juvenile idiopathic arthritis / United States - epidemiology