Objective: To analyze the related severe adverse events (SAE) of rituximab (RTX) in children with primary nephrotic syndrome (PNS)

explore the related risk factors of SAE in the treatment of children with RTX during PNS

and provide a reference for the safe use of RTX in clinical practice. Methods: A retrospective study was carried out based on the data of children with PNS treated with RTX from December 2016 to December 2020 in the Department of Kidney and Immunology

Children’ s Hospital of Soochow University

including the patient’s gender

age

name of SAE and specific clinical manifestations. Multivariate analysis was performed using Cox regression to analyze the SAE related causes. Kaplan-Meier curve was used to describe the changes of survival

and Log-Rank test was used to compare the differences of survival curves. Results: A total of 44 children with PNS were collected. The age of onset was 4. 73±0. 35 years old

the age of initial RTX use was 10. 16±3. 47 years old

and the follow-up time was 1. 50(2. 05)years. Of the 44 patients

12 had at least one SAE that may be related to RTX. There were 10 male patients (83. 33%) and 2 female patients (16. 67%). Hypersensitivity reactions and infections were the more common SAE. Age at initial RTX use was a risk factor for SAE. The risk of SAE was reduced by 23. 8% for each 1-year increase in age at initiation of RTX. Conclusion: RTX is generally considered safe in children. Younger children are at higher risk of SAE with RTX.