#358 The efficacy and safety of ripertamab (SCT400) in the treatment of primary membranous nephropathy: a single center retrospective study

Abstract

Abstract Background and Aims Anti-CD20 monoclonal antibody is gaining increasing clinical acceptance in the treatment of primary membranous nephropathy (PMN). Ripertamab, a novel anti-CD20 monoclonal antibody developed in China, has been shown to be non-inferior to rituximab in efficacy and safety in patients with B-cell non Hodgkin's lymphoma. We aimed to identify the efficacy and safety of ripertamab in PMN retrospectively. Method The PMN patients who were diagnosed by renal biopsy and received ripertamab-based therapy between November 1 2022 and June 30 2023 were included. The inclusion criteria were: aged ≥ 18 years, and total B-lymphocyte ratio < 1% after using ripertamab. The exclusion criteria were: follow-up < 6 months, incomplete clinical data, secondary membranous nephropathy due to malignant tumor, systemic lupus erythematosus, hepatitis, etc. The primary outcome was clinical efficacy at 6 months after initial of treatment and secondary outcomes were clinical efficacy at 3 months, safety and the occurrence of adverse events. Complete remission (CR) was defined as urine protein/creatinine ratio (UPCR) < 300 mg/g or 24-hour urinary protein (UP) < 0.3 g, serum albumin >35 g, and stable renal function (eGFR with ≤50% reduction compared with baseline). Partial remission (PR) was defined as UPCR or UP with ≥ 50% reduction compared with baseline, serum albumin >30 g, and stable renal function. No response (NR) was defined as UPCR or UP with < 50% reduction compared with baseline. Results A total of 31 patients were included in this retrospective study. The baseline characteristics of the study population and ripertamab treatment responses were described in Table 1. At 6 months, 20 of 31 (64.6%) patients achieved CR (n = 10, 32.3%) or PR (n = 10, 32.3%) after ripertamab treatment (Table 2). Furthermore, 21 of 31 (67.7%) patients who were not given any immunosuppressive therapy before receiving ripertamab achieved CR or PR. Non-responders showed a higher level of proteinuria and a worse renal function at baseline than those of responders. All patients achieved complete B-cell depletion. No adverse events were observed in patients in this study. Conclusion Ripertamab can effectively induce remission of PMN and have a favorable safety profile.