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CLINICAL TRIAL article

Front. Immunol.

Sec. Autoimmune and Autoinflammatory Disorders : Autoimmune Disorders

Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1633532

This article is part of the Research TopicAutoimmune Diseases: from molecular mechanisms to therapy developmentView all 20 articles

B cell and anti-PLA2R antibody-guided rituximab therapy in idiopathic membranous nephropathy: a prospective multi-center cohort study in the east coastal region of China

Provisionally accepted
Yili XuYili Xu1Liang WangLiang Wang2Chunming JiangChunming Jiang3Dong SunDong Sun4Min YangMin Yang5Jin LiuJin Liu1Xiaobin LiuXiaobin Liu2Cheng WanCheng Wan3Caixia LiuCaixia Liu4Bo ZhangBo Zhang1Guangyu BiGuangyu Bi6Lianhua ChenLianhua Chen7Liyuan ZhangLiyuan Zhang8Guoyuan LuGuoyuan Lu9Liang ZhangLiang Zhang10Hua ZhouHua Zhou5Xiaobo ZhangXiaobo Zhang8Gang ZhouGang Zhou11Fang LuFang Lu1Chengning ZhangChengning Zhang1Bin SunBin Sun1Ming ZengMing Zeng1Shuaibo BianShuaibo Bian10Li ZhangLi Zhang1Ningning WangNingning Wang1Lei ShenLei Shen9Yanggang YUANYanggang YUAN1*Chang XingChang Xing1*Huijuan MaoHuijuan Mao1*
  • 1First Affiliated Hospital, Nanjing Medical University, Nanjing, China
  • 2Wuxi People’s Hospital Affiliated to Nanjing Medical University, Wuxi, Jiangsu Province, China
  • 3Department of Nephrology, Nanjing Drum Tower Hospital, Nanjing, Jiangsu Province, China
  • 4The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province, China
  • 5First People's Hospital of Changzhou, Changzhou, Jiangsu Province, China
  • 6Northern Jiangsu People's Hospital, Yangzhou University, Yangzhou, Jiangsu Province, China
  • 7Huai'an First People's Hospital, Huai'an, Jiangsu, China
  • 8Huaian First People's Hospital, Huaian, China
  • 9First Affiliated Hospital of Soochow University, Suzhou, China
  • 10Suqian First Hospital, Suqian, China
  • 11Northern Jiangsu People's Hospital, Yangzhou, China

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Abstract Introduction: This study assessed the safety and efficacy of B cell and anti-PLA2R antibody targeted low-dose rituximab therapy in patients with IMN. Methods: It is a multicenter, investigator-initiated, open-label, prospective cohort study. Recruited patients were identified from ten hospitals in the east coastal region of China between November 1st, 2019 to June 15th, 2023. In this study, enrolled patients were assigned to individualized Rituximab therapy (Peripheral B cells and anti-PLA2R targeted) and the standard Rituximab therapy (1000mg X 2 or 375mg/m2 X 3~4) accordingly: the individualized group (n=78), the standardized group (n=62). Odds ratio (OR) and 95%CIs for response were estimated using multivariate logistic regression models, adjusting for key confounders in the cohort, with inverse probability of treatment weighting (IPTW) to adjust for demographic and clinical characteristics. The primary outcome was a composite of complete or partial remission of proteinuria. Results: A total of 140 patients' data were available for statistical analysis. The analysis was completed on June 10th, 2024. Characteristics were well-balanced between the two groups after IPTW. Patients were followed up every 2 months for one year from the first injection of Rituximab. At 12 months, 57 out of 78 patients (73.1%) in the individualized therapy group and 40 of 62 (64.5%) in the standard therapy group had complete or partial remission [The Adjust Risk Difference of response and 95% confidence interval were 0.1(-0.05 to 0.26); P=0.001 for noninferiority]. In weighted cohort, 74.1% in the individualized therapy group and 70.5% in the standard therapy group had complete or partial remission (p=0.5). The median (interquartile range) of

Keywords: Idiopathic membranous nephropathy, rituximab, targets driven, prospective cohort, Non-randomized clinical trials

Received: 22 May 2025; Accepted: 25 Aug 2025.

Copyright: © 2025 Xu, Wang, Jiang, Sun, Yang, Liu, Liu, Wan, Liu, Zhang, Bi, Chen, Zhang, Lu, Zhang, Zhou, Zhang, Zhou, Lu, Zhang, Sun, Zeng, Bian, Zhang, Wang, Shen, YUAN, Xing and Mao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Yanggang YUAN, First Affiliated Hospital, Nanjing Medical University, Nanjing, China
Chang Xing, First Affiliated Hospital, Nanjing Medical University, Nanjing, China
Huijuan Mao, First Affiliated Hospital, Nanjing Medical University, Nanjing, China

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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