Chinese Journal of Evidence-Based Pediatrics ›› 2023, Vol. 18 ›› Issue (1): 21-26.DOI: 10.3969/j.issn.1673-5501.2023.01.003

Previous Articles     Next Articles

Adverse events of rituximab for children with steroid-sensitive nephrotic syndrome: A systematic review and meta-analysis

SHAO Leilin1a, LIU Jialu1a, CHEN Qiuxia2, SHEN Qian1a, ZHANG Chongfan1b,  WANG Huishan1b, WANG Yingwen1c, ZHANG Aihua2, XIA Zhengkun3, XU Hong1a   

  1. 1 Children's Hospital of Fudan University, Shanghai 201102, China, a Department of Nephrology, Shanghai Kidney Development and Pediatric Kidney Disease Research Center, b Fudan University GRADE Center, c Department of Nursing; 2 Department of Nephrology, Children's Hospital of Nanjing Medical University, Nanjing 210093, China; 3 General Hospital of the Eastern Theater of the Chinese People's Liberation Army, Nanjing 210002, China
  • Received:2023-04-04 Revised:2023-04-04 Online:2023-02-25 Published:2023-02-25
  • Contact: XU Hong, email: hxu@shmu.edu.cn;ZHANG Aihua, email: bszah@163.com

Abstract: Background:Over the past 20 years, rituximab (RTX) has shown better efficacy than other immunosuppressants in the treatment of children with steroid-sensitive nephrotic syndrome (SSNS), but reports of adverse events still need to be accumulated. Objective:To understand the adverse events of rituximab for children with SSNS. Design:Systematic review and meta-analysis. Methods:PubMed, Embase, Cochrane, Scopus and Chinese Biology Medicine databases were searched from the inception to June 26, 2022, with the keywords of SSNS and RTX. The preliminary screening, full text screening and data extraction were all completed by the same two reviewers. Unsure or controversial literature was submitted to a third reviewer. At least one RTX intervention for children aged between 1 and 22 years with SSNS was included. Main outcome measures:The incidences of adverse events. Results:A total of 47 studies (5 in Chinese and 42 in English) were included in the analysis, including 7 doublearm intervention studies (5 randomized controlled trials, 2 nonrandomized study) and 40 case series reports. Comparing RTX with placebo or conventional immunosuppressants (control group) in SSNS children, there were no statistically significant differences in the incidences of adverse events (7 studies, 130/184 vs 107/177), serious adverse events (4 studies, 14/140 vs 9/122), infusion reaction (1 study, 19/24 vs 13/24) and infection (2 studies, 33/56 vs 23/38). In case series reports of SSNS children treated with RTX, the incidences of adverse events, serious adverse events, infusion reaction, infection and serum sickness were 59 percent (95%CI: 55 percent to 63percent), 7 percent (95%CI: 6 percent to 9 percent),31 percent (95%CI: 28 percent to 35 percent), 21 percent (95%CI: 18 percent to 24 percent) and 5 percent (95%CI: 2 percent to 10 percent), respectively. Studies reporting both neutropenia and agranulocytosis revealed the incidence of neutropenia was 9 percent (95%CI: 5 percent to 17 percent) and the incidence of agranulocytosis was 4 percent (95%CI: 2 percent to 10 percent). Studies focusing on hypogammaglobulinemia revealed the incidence of hypogammaglobulinemia was 51 percent (95%CI: 42 percent to 60 percent). Conclusions:RTX treatment of SSNS did not increase the incidences of adverse events, serious adverse events and infection, but hypogammaglobulinemia and serum sickness should be of concern.

Key words: Children, Steroid-sensitive nephrotic syndrome, Rituximab, Adverse events, Safety