The Efficacy and Safety of Early Treatment with Rituximab in Children with steroid-sensitive Nephrotic Syndrome: A Randomized Controlled Trial

Objective: To evaluate the efficacy and safety of early Rituximab (RTX) treatment in reducing relapses within two years for newly diagnosed steroid-sensitive nephrotic syndrome (SSNS). Methods: A randomized controlled trial was conducted in the Anhui Children's Hospital from June 2021 to February 2022. This prospective study included 30 children diagnosed with initial SSNS who were randomly divided into RTX and steroid control groups. The RTX group received 375 mg/m2 RTX within one week, while the control group underwent standard treatment according to current evidence-based guidelines. Kaplan-Meier analysis was used to assess relapse-free survival rates and the incidence of frequent relapsing nephrotic syndrome/steroid-dependent nephrotic syndrome (FRNS/SDNS). Analysis of variance was employed to evaluate IL-8 levels before and after treatment. Results: The two-year survival curves, with relapse as the endpoint event, showed significant differences between the RTX and steroid control groups (log-rank test c2=5.49, P<0.05). The two-year relapse-free survival rates were 57.14% and 21.42% for the RTX and control groups, respectively. In the RTX group, IL-18 decreased significantly from 55.90±12.36 pre-treatment to 24.98±1.96 one month post-treatment (P<0.05). Conclusion: Early RTX treatment can improve relapse-free survival rates in pediatric SSNS patients. IL-18 levels decrease one month after RTX treatment. This therapy is relatively safe, and no severe adverse reactions were observed.