{"title":"b细胞驱动的利妥昔单抗治疗难治性特发性膜性肾病的疗效和安全性","authors":"Kaiqi Guo, Huaxia Zhu, Xingcheng Xu, Lanlan Huang, Huimin Li, Xiaowei Li","doi":"10.1186/s40360-025-00954-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Rituximab (RTX) is known to be effective in the treatment of idiopathic membranous nephropathy (IMN), but the specific dosing regimens have not been standardized. The aim of this retrospective study was to assess the clinical efficacy and safety of a B-cell-driven RTX regimen for the treatment of refractory IMN.</p><p><strong>Methods: </strong>The data of 24 refractory IMN patients who underwent a B-cell-driven RTX regimen at Fuyang People's Hospital of Anhui Medical University between October 2018 and November 2021 were retrospectively analysed.</p><p><strong>Results: </strong>In total, 24 patients, comprising 17 males, with a mean age of 52.17 ± 8.28 years, were enrolled. After treatment with the B-cell-driven RTX regimen, 4 (16.67%) patients achieved complete remission, 11 (45.83%) patients achieved partial remission, the overall treatment efficacy was 62.50%, and there were 4 (16.67%) cases of relapse. The cumulative remission RTX dose was 2.40 g (IQR, 2.10 to 3.50), and the total cumulative RTX dose was 2.85 g (IQR, 2.40 to 4.20). B-cell depletion was achieved in 23 (95.83%) patients after the first dose of RTX was applied and in 1 patient after the second dose of RTX was applied. There was a significant difference in clinical remission between patients with and without a change in anti-PLA2R antibody status from positive to negative (P < 0.001). Two (8.33%) patients experienced infusion reactions, and 5 (20.83%) patients experienced nonserious infections. Treatment was discontinued in one patient due to severe pneumonia.</p><p><strong>Conclusion: </strong>A B-cell-driven RTX regimen can induce partial or complete remission in patients with refractory IMN and is safe.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"131"},"PeriodicalIF":2.8000,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12232057/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of a B-cell-driven rituximab regimen for the treatment of refractory idiopathic membranous nephropathy.\",\"authors\":\"Kaiqi Guo, Huaxia Zhu, Xingcheng Xu, Lanlan Huang, Huimin Li, Xiaowei Li\",\"doi\":\"10.1186/s40360-025-00954-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Rituximab (RTX) is known to be effective in the treatment of idiopathic membranous nephropathy (IMN), but the specific dosing regimens have not been standardized. The aim of this retrospective study was to assess the clinical efficacy and safety of a B-cell-driven RTX regimen for the treatment of refractory IMN.</p><p><strong>Methods: </strong>The data of 24 refractory IMN patients who underwent a B-cell-driven RTX regimen at Fuyang People's Hospital of Anhui Medical University between October 2018 and November 2021 were retrospectively analysed.</p><p><strong>Results: </strong>In total, 24 patients, comprising 17 males, with a mean age of 52.17 ± 8.28 years, were enrolled. After treatment with the B-cell-driven RTX regimen, 4 (16.67%) patients achieved complete remission, 11 (45.83%) patients achieved partial remission, the overall treatment efficacy was 62.50%, and there were 4 (16.67%) cases of relapse. The cumulative remission RTX dose was 2.40 g (IQR, 2.10 to 3.50), and the total cumulative RTX dose was 2.85 g (IQR, 2.40 to 4.20). B-cell depletion was achieved in 23 (95.83%) patients after the first dose of RTX was applied and in 1 patient after the second dose of RTX was applied. There was a significant difference in clinical remission between patients with and without a change in anti-PLA2R antibody status from positive to negative (P < 0.001). Two (8.33%) patients experienced infusion reactions, and 5 (20.83%) patients experienced nonserious infections. Treatment was discontinued in one patient due to severe pneumonia.</p><p><strong>Conclusion: </strong>A B-cell-driven RTX regimen can induce partial or complete remission in patients with refractory IMN and is safe.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>\",\"PeriodicalId\":9023,\"journal\":{\"name\":\"BMC Pharmacology & Toxicology\",\"volume\":\"26 1\",\"pages\":\"131\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-07-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12232057/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Pharmacology & Toxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s40360-025-00954-8\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Pharmacology & Toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s40360-025-00954-8","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
背景:利妥昔单抗(RTX)已知对特发性膜性肾病(IMN)有效,但具体给药方案尚未标准化。这项回顾性研究的目的是评估b细胞驱动RTX方案治疗难治性IMN的临床疗效和安全性。方法:回顾性分析2018年10月至2021年11月在安徽医科大学阜阳人民医院接受b细胞驱动RTX治疗的24例难治性IMN患者的资料。结果:共纳入24例患者,其中男性17例,平均年龄52.17±8.28岁。经b细胞驱动RTX方案治疗后,完全缓解4例(16.67%),部分缓解11例(45.83%),总疗效62.50%,复发4例(16.67%)。累计缓解RTX剂量为2.40 g (IQR, 2.10 ~ 3.50),累计RTX总剂量为2.85 g (IQR, 2.40 ~ 4.20)。第一次给药后,23例(95.83%)患者b细胞消失,第二次给药后,1例患者b细胞消失。抗pla2r抗体状态从阳性到阴性变化的患者和未发生抗pla2r抗体状态从阳性到阴性变化的患者的临床缓解有显著差异(P)结论:b细胞驱动的RTX方案可以诱导难治性IMN患者部分或完全缓解,并且是安全的。临床试验号:不适用。
Efficacy and safety of a B-cell-driven rituximab regimen for the treatment of refractory idiopathic membranous nephropathy.
Background: Rituximab (RTX) is known to be effective in the treatment of idiopathic membranous nephropathy (IMN), but the specific dosing regimens have not been standardized. The aim of this retrospective study was to assess the clinical efficacy and safety of a B-cell-driven RTX regimen for the treatment of refractory IMN.
Methods: The data of 24 refractory IMN patients who underwent a B-cell-driven RTX regimen at Fuyang People's Hospital of Anhui Medical University between October 2018 and November 2021 were retrospectively analysed.
Results: In total, 24 patients, comprising 17 males, with a mean age of 52.17 ± 8.28 years, were enrolled. After treatment with the B-cell-driven RTX regimen, 4 (16.67%) patients achieved complete remission, 11 (45.83%) patients achieved partial remission, the overall treatment efficacy was 62.50%, and there were 4 (16.67%) cases of relapse. The cumulative remission RTX dose was 2.40 g (IQR, 2.10 to 3.50), and the total cumulative RTX dose was 2.85 g (IQR, 2.40 to 4.20). B-cell depletion was achieved in 23 (95.83%) patients after the first dose of RTX was applied and in 1 patient after the second dose of RTX was applied. There was a significant difference in clinical remission between patients with and without a change in anti-PLA2R antibody status from positive to negative (P < 0.001). Two (8.33%) patients experienced infusion reactions, and 5 (20.83%) patients experienced nonserious infections. Treatment was discontinued in one patient due to severe pneumonia.
Conclusion: A B-cell-driven RTX regimen can induce partial or complete remission in patients with refractory IMN and is safe.
期刊介绍:
BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.