Efficacy and Safety of Rituximab Second-Line Therapy for Membranous Nephropathy: A Prospective, Matched-Cohort Study

Efficacy and Safety of Rituximab Second-Line Therapy for Membranous Nephropathy: A Prospective, Matched-Cohort Study
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DOI:
10.1159/000327611
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发表时间:
2011-01-01
影响因子:
4.2
通讯作者:
Ruggenenti, Piero
Ruggenenti, Piero
中科院分区:
医学3区
文献类型:
--
作者:
Cravedi, Paolo;Sghirlanzoni, Maria Chiara;Ruggenenti, Piero

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背景/目标:在继发于特发性膜性肾病(IMN)的肾病综合征(NS)患者中,使用B细胞耗竭抗体利妥昔单抗进行一线免疫抑制可减少蛋白尿并诱导疾病缓解。在这里,我们评估了利妥昔单抗是否对既往免疫抑制治疗无效的患者同样有效。研究方法:这项学术、配对队列研究比较了11例连续IMN患者的2年结局,这些患者接受二线利妥昔单抗治疗NS,这些患者在既往单独使用类固醇或联合烷化剂、环孢素或免疫球蛋白G治疗后持续或复发,(+/- 5岁),性别和蛋白尿-(+/- 1 g/24 h)匹配的参考患者给予一线利妥昔单抗治疗。结果:患者和参考患者的基线特征相似。与基线相比,利妥昔单抗治疗后1年和2年,24小时蛋白尿同样下降(患者分别下降50.5 +/- 25.1%和60.9 +/- 17.4%,参考患者分别下降52.7 +/- 31.5%和69.4 +/- 40.4%;所有比较与基线相比,p < 0.01)。8例患者和7例参考患者实现完全(3 vs. 2)或部分(每个队列5例)蛋白尿缓解。两组的低白蛋白血症和高脂血症均正常化。每个队列1例受试者发生自限性输注相关反应。结论:利妥昔单抗降低非选择性免疫抑制无反应或仅有短暂反应的IMN患者的蛋白尿与既往无免疫抑制的患者一样有效和安全。版权所有(C)2011 S. Karger AG,巴塞尔
Background/Aims: First-line immunosuppression with the B-cell depleting antibody rituximab reduced proteinuria and induced remission of the disease in patients with nephrotic syndrome (NS) secondary to idiopathic membranous nephropathy (IMN). Here we evaluated whether rituximab is equally effective in patients who failed to respond to previous immunosuppressive treatment. Methods: This academic, matched-cohort study, compared 2-year outcomes of 11 consecutive IMN patients who received second-line rituximab therapy for NS persisting or relapsing after previous treatment with steroids alone or combined with alkylating agents, cyclosporine, or immunoglobulin G, with those of 11 age- (+/- 5 years), gender-and proteinuria-(+/- 1 g/24h) matched reference patients given first-line rituximab therapy. Results: Patients' and reference patients' baseline characteristics were similar. Compared to baseline, 24-hour proteinuria similarly declined at 1 and 2 years post-rituximab (by 50.5 +/- 25.1% and 60.9 +/- 17.4% in patients and by 52.7 +/- 31.5% and 69.4 +/- 40.4% in reference patients, respectively; p < 0.01 for all comparisons vs. baseline). 8 patients and 7 reference patients achieved full (3 vs. 2) or partial (5 per cohort) proteinuria remission. Hypoalbunninemia and hyperlipidemia normalized in both groups. Self-limited infusion-related reactions occurred in 1 subject per cohort. Conclusion: Rituximab reduced proteinuria in IMN patients with no or only transient response to unselective immunosuppression as effectively and safely as in patients without previous immunosuppression. Copyright (C) 2011 S. Karger AG, Basel