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Kidney Week

Abstract: FR-PO672

Efficacy and Safety of Single-Dose Rituximab Biosimilar in the Initial Episode of Paediatric Steroid-Sensitive Nephrotic Syndrome

Session Information

  • Pediatric Nephrology - II
    November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Pediatric Nephrology

  • 1900 Pediatric Nephrology

Authors

  • Jialu, Liu, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, China
  • Xu, Hong, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, China
  • Shen, Qian, Children’s Hospital of Fudan University, National Children’s Medical Center, Shanghai, China
Background

The 12-month relapse-free survival rate is less than 30% in steroid-sensitive nephrotic syndrome (SSNS) children after the standard corticosteroid therapy. Rituximab is effective in reducing the relapse in children with frequent relapse or steroid dependent NS. Accordingly, we hypothesize rituximab added to guideline-recommended corticosteroid therapy is effective for maintaining remission for the first year of onset.

Methods

An open-label, single-arm, multicentre trial was performed at eight centers in China with a 12-month follow-up (NCT04783675). The first episode of SSNS children treated with standard corticosteroids was eligible for inclusion. Eligible patients received a single dose of 375 mg/m2 rituximab biosimilar within one week after achieving remission. The primary outcome was the 12-month relapse-free survival rate after rituximab was added to corticosteroid therapy, was compared with historical controls treated without rituximab on NCT03878914.

Results

Totally, 44 children were treated with rituximab and all but one patient completed one year of follow-up. Rituximab therapy was associated with a significantly higher 12-month relapse-free survival rate than the historical control (32 [74.4%] vs 10 [30.3%] children; P <0.001; hazard ratio, 1.89; 95%CI, 1.15-3.11). The median time to first relapse was 123 days (95%CI, 73 to 201 days). The treatment was well tolerated. During infusion, three participants reported throat irritation. Besides two patients with a decreased neutrophil count, all other adverse events were fully resolved.

Conclusion

In children with the initial episode of SSNS, rituximab appears to be an effective and safe treatment for maintaining disease remission. It provides evidence for the initial treatment strategy of SSNS in children to prevent the recurrence.