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Abstract: PO2339

Risk of Rituximab-Associated Severe Adverse Events Increases with Young Age in Children with Nephrotic Syndrome

Session Information

Category: Pediatric Nephrology

  • 1700 Pediatric Nephrology

Authors

  • Laroche, Camille, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
  • Lemieux, Dominique, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
  • Lapeyraque, Anne-Laure, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
  • Flahault, Adrien, Centre Hospitalier Universitaire Sainte-Justine Centre de Recherche, Montreal, Quebec, Canada
Background

Rituximab prevents relapse in steroid-dependent frequently relapsing nephrotic syndrome (SDFRNS). We aimed to assess the safety of rituximab in children with steroid-resistant nephrotic syndrome (SRNS) or SDFRNS.

Methods

This single-center retrospective study included all children with SRNS/SDFRNS treated with rituximab since 2007 at our institution. All information concerning adverse events (AE) were obtained from medical records. Severity of adverse events was graded according to the Common Terminology Criteria for Adverse Events. We performed a survival analysis and log-rank tests or proportional hazards models to determine hazard ratios (HR) with 95% confidence intervals (CI) of risk factors associated with severe AE (SAE).

Results

Of the 38 children included in this study, most had a SDFRNS (n=36, 95%). Median age at diagnostic was 3.4 (interquartile range, 2.4-6.2) years and median age at rituximab initiation was 9.0 (6.8-13.6) years. Median [95% CI] time to relapse was 1.4 [1.16-2.27] years. Median follow-up time was 3.7 (2.2-4.9) years. No patient died during follow-up. Fourteen SAE occurred in 12 (32%) patients, including one case of Pneumocystis jiroveci pneumonia, 6 cases of severe neutropenia and 2 cases of inflammatory colitis. Rituximab initiation before 10 years of age was associated with a higher risk of SAE (HR [95%CI], 11.3 [1.44, 88.6], Figure 1) and all SAE occurred in children aged <10 years except for anaphylactic reactions. The occurrence of a SAE was not associated with an increased risk of relapse.

Conclusion

A young age at rituximab initiation for SRNS/SDFRNS is associated with an increased risk of SAE. Rituximab should be used with particular caution in children under 10 years old.

Funding

  • Government Support - Non-U.S.