Abstract Background Rituximab (RTX) is a monoclonal antibody targeting CD20, recommended by KDIGO guideline as fist line treatment for membranous nephropathy (MN). RTX biosimilar is the first biosimilar licensed in China in 2019 as HLX01. However, its efficacy and safety for MN treatment is unclear. This study aimed to evaluate the the performance of RTX biosimilar for MN in the real-world setting. Methods This study retrospectively collected the medical records of 201 inpatients of MN treated with high-dose RTX biosimilar and followed up for one year from January 2020 to December 2022 at PUMCH. The efficacy was evaluated according to KDIGO guideline. Adverse reactions recorded in medical records during or after infusion were collected. Results Within one year of follow-up period, the overall effective rate of high-dose RTX biosimilar treatment for MN was 75.12% (151/201) with 53 patients achieving complete remission and 98 patients reaching partial remission. The median time to remission was 6 months. Among patients who gained remission, relapse rate was 7.95% (12/151) and among whom 7 patients gained remission again after re-administration. The overall effective rate was 78.79% (52/66) for treatment-naïve patients and 73.33% (99/135) for treated patients (P = 0.401). The adverse reactions included pruritus, flushed face, hypotension, fever, rash, oropharyngeal discomfort, chest distress, eyelid edema, nausea and vomiting, blocked or watery nose, with an overall incidence of 30.85% (62/201). Conclusions Rituximab biosimilar has acceptable efficacy and safety for MN patients, and the outcome is similar with that of innovator RTX product reported in literature, which may be taken as an alternative to innovator RTX as first-line treatment for MN.
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Zou et al. (2024) studied this question.
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