A novel approach to induce early remission in high-risk primary membranous nephropathy.

IF 4.8 2区医学 Q1 TRANSPLANTATION

Nephrology Dialysis Transplantation Pub Date : 2024-12-20 DOI:10.1093/ndt/gfae138

Zinaida Kochoyan, Vladimir A Dobronravov

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引用次数: 0

Abstract

Background: This prospective single-arm trial with historic controls evaluated the efficacy and safety of treatment based on a combination of rituximab, intravenous cyclophosphamide and corticosteroids (RCP) administered at lower cumulative doses for the induction of early remission in primary membranous nephropathy (PMN).

Methods: We prospectively enrolled 30 high-risk PMN patients with persistent nephrotic syndrome (NS) and elevated antibodies to the phospholipase A2 receptor who underwent RCP therapy. We compared the effectiveness of RCP with that of historic controls who received rituximab-based therapy (RTX, n = 15) or cyclosporine + corticosteroids (CSA, n = 42). The primary outcomes were complete remission (CR) and overall remission (OR) by Month 12 and the time to remission.

Results: In the RCP group, the OR and CR rates by 12 months (97% and 60%) were higher than those in the RTX group (60% and 7%, P ≤ .009) and the CSA group (50% and 24%, P ≤ .003). The median time to OR [2.8 (1.6-3.9) months] was shorter compared with RTX [7.1 (3.4-17.5) months, P = .008] and CSA [7.3 (6.0-13.6) months, P < .001]. In adjusted Cox regression, hazard ratios for OR and CR attainment for RCP versus other treatments were 5.2 (95% CI 2.8-9.6) and 4.8 (95% CI 2.2-10.3), respectively. Propensity score-matched group analyses confirmed these results. One serious adverse event occurred in the RCP group in the follow-up of 56 patient-years.

Conclusions: RCP therapy is considered effective and safe for inducing early remission in high-risk PMN patients.

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诱导高风险原发性膜性肾病早期缓解的新方法。

背景与假设这项有历史对照的前瞻性单臂试验评估了基于较低累积剂量的利妥昔单抗、静脉注射环磷酰胺和皮质类固醇（RCP）联合疗法诱导原发性膜性肾病（PMN）早期缓解的疗效和安全性：我们前瞻性地招募了30名患有顽固性肾病综合征（NS）和磷脂酶A2受体抗体升高的高危原发性膜性肾病患者，他们都接受了RCP治疗。我们将 RCP 的疗效与接受利妥昔单抗疗法（RTX，n = 15）或环孢素+皮质类固醇疗法（CSA，n = 42）的历史对照组进行了比较。主要结果是第12个月时的完全缓解（CR）和总体缓解（OR）以及达到缓解的时间：RCP组12个月的OR和CR率（97%和60%）高于RTX组（60%和7%，P≤0.009）和CSA组（50%和24%，P≤0.003）。与RTX（7.1（3.4-17.5）个月，P = 0.008）和CSA（7.3（6.0-13.6）个月，P 结论：RCP治疗被认为是有效和安全的：RCP疗法被认为是诱导高危PMN患者早期缓解的有效且安全的方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nephrology Dialysis Transplantation 医学-泌尿学与肾脏学

CiteScore

10.10

自引率

4.90%

发文量

1431

审稿时长

1.7 months

期刊介绍： Nephrology Dialysis Transplantation (ndt) is the leading nephrology journal in Europe and renowned worldwide, devoted to original clinical and laboratory research in nephrology, dialysis and transplantation. ndt is an official journal of the [ERA-EDTA](http://www.era-edta.org/) (European Renal Association-European Dialysis and Transplant Association). Published monthly, the journal provides an essential resource for researchers and clinicians throughout the world. All research articles in this journal have undergone peer review. Print ISSN: 0931-0509.