Rituximab as a Maintenance Therapy in Pediatric Patients with Frequent-Relapsing or Steroid Dependent Nephrotic Syndrome: Efficacy, Safety, and Steroid Reduction

Abstract Background: Nephrotic syndrome is the most common glomerular disease in pediatrics. Rituximab has been shown to induce remission in nephrotic syndrome, yet the necessity and safety of its use in maintenance therapy remain uncertain. In this study, we detail our clinical experience with the application of rituximab in the maintenance treatment of pediatric nephrotic syndrome, aiming to offer an additional therapeutic option for patients. Methods: In a retrospective study conducted at the Second Xiangya Hospital of Central South University from January 2020 to June 2023, we evaluated pediatric patients with frequent-relapsing or steroid-dependent nephrotic syndrome who received rituximab treatment. All patients received induction therapy with rituximab for remission. Based on the subsequent maintenance treatment regimen, patients were divided into two groups: Group 1 (n=12) received traditional immunosuppressive therapy for maintenance, and Group 2 (n=23) received rituximab maintenance every six months. We collected and analyzed data regarding steroid discontinuation, treatment outcomes, and the incidence of adverse events. Results: The primary outcomes measured were steroid discontinuation rate and the minimum steroid dosage required to maintain remission. Group 2 exhibited a significantly higher steroid withdrawal rate (P<0.05) and a lower minimum steroid dose for remission maintenance (P<0.05) compared to Group 1. However, the differences in steroid-free survival time (P=0.390), time to first recurrence (P=0.794), and relapse-free survival duration (P=0.199) between the two groups were not statistically significant. Adverse events were observed in both groups, with infusion reactions and infections being the most common. No serious adverse events were reported in either group. Conclusions: In conclusion, our retrospective analysis demonstrates that rituximab maintenance therapy is an effective strategy for managing pediatric patients with frequent-relapsing or steroid-dependent nephrotic syndrome. The therapy significantly increased the steroid withdrawal rate and reduced the required steroid dosage, thereby potentially mitigating the long-term adverse effects associated with steroid use. The side effects observed were acceptable.