A prospective cohort study of rituximab in the treatment of refractory nephrotic syndrome

Jing Xu,Zhen Qu,Li Wan,Ying Ding,Qinghua Yang

doi:10.1007/s11255-021-02860-4

Abstract

ObjectiveTo explore the efficacy and safety of rituximab (RTX) in the treatment of autoimmune nephropathy manifested as refractory nephrotic syndrome (RNS).MethodsA single-center prospective cohort study was conducted on RNS patients treated with RTX between March 2017 and December 2019. The subjects were divided into the primary nephropathy (PN) group and the secondary nephropathy (SN) group. Based on the estimated glomerular filtration rate (eGFR) before RTX treatment, the SN group was then divided into the SN-1 group (eGFR ≥ 30 ml/min) and the SN-2 group (eGFR < 30 ml/min). Biochemical parameters and clinical data were recorded during follow-up.ResultsFifty-four patients were followed up for at least 6 months. The overall remission rates were 65%, 66.7%, 27.3% in the PN, SN-1, and SN-2 groups, respectively (P = 0.022). Kaplan–Meier analysis showed a significant difference of the renal survival among the three subgroups (P < 0.001). Multivariate Cox regression analysis showed that eGFR value before treatment was an independent predictor (HR 0.919, 95%CI 0.863–0.979) for renal survival. In terms of adverse events, infection accounted for 56.6%. The incidence of severe infection was 10%, 25% and 50% in PN group, SN-1 group and SN-2 group, respectively.ConclusionsRTX may be a promising option in RNS patients with eGFR ≥ 30 ml/min/1.73m2. However, it has little effect on prognosis in patients with secondary RNS with eGFR < 30 ml/min/1.73m2, but with a high risk of severe infection.

Highlights

Rituximab (RTX), a chimeric anti-CD20 monoclonal antibody, has been initially approved for the treatment of nonHodgkin’s lymphoma [1]
The indications of RTX as an immunosuppressive agent have extended to primary glomerular diseases such as idiopathic membranous nephropathy (IMN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and nephropathy secondary to autoimmune diseases such as anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV), lupus nephritis (LN), thrombotic microangiopathy (TMA)
In the secondary nephropathy (SN)-1 (n = 12) and SN-2 (n = 22) groups, the primary diseases leading to NC include systemic lupus erythematosus (SLE), AAV, and complement-mediated HUS (C-HUS) (Table 1)

Summary

Introduction

Rituximab (RTX), a chimeric anti-CD20 monoclonal antibody, has been initially approved for the treatment of nonHodgkin’s lymphoma [1]. The indications of RTX as an immunosuppressive agent have extended to primary glomerular diseases such as idiopathic membranous nephropathy (IMN), minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and nephropathy secondary to autoimmune diseases such as anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV), lupus nephritis (LN), thrombotic microangiopathy (TMA). In terms of primary glomerular diseases, the efficacy and safety of RTX in the treatment of IMN have been proved. Dahan et al [2] found a positive effect of RTX on proteinuria remission in IMN patients and proved that addition of RTX to non-immunosuppressive antiproteinuric treatment (NIAT) does not affect safety. GEMRITUX study [4] has reported that in the treatment of IMN, using RTX alone has similar efficacy and fewer side effects compared with a combination of glucocorticoids and cyclophosphamide. In terms of nephropathy secondary to autoimmune diseases, Rovin’s study [11] has shown no statistical difference in

Methods

Results

Conclusion