替利他塞普与霉酚酸酯治疗IgA肾病:疗效、肾脏结局和安全性的现实世界比较研究

IF 4.6 2区 医学 Q1 UROLOGY & NEPHROLOGY
Clinical Kidney Journal Pub Date : 2025-08-12 eCollection Date: 2025-09-01 DOI:10.1093/ckj/sfaf261
Yangyang He, Shasha Chen, Kaixiang Liu, Xintong Wu, Min Yu, Wei Wang, Kun Peng, Li Wang, Guisen Li, Xisheng Xie, Wei Qin, Xiang Zhong
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引用次数: 0

摘要

背景:本研究旨在评估telitacicept与霉酚酸酯(MMF)在高危进行性免疫球蛋白A肾病(IgAN)中的疗效和安全性。方法:这项回顾性、多中心队列研究纳入了接受telitacicept或MMF联合低剂量类固醇治疗的高风险进行性IgAN患者。从治疗开始到12个月收集临床数据。结果:共纳入104例患者,其中56例接受MMF治疗,48例接受telitacicept治疗。平均年龄36.9±11.8岁。基线特征在各组间平衡良好,但血清白蛋白、尿酸和基于牛津分类的肾小管病理存在显著差异。在12个月时,telitacicept联合低剂量类固醇显示出更好的蛋白尿减少(-62.5%对-52.9%,P = 0.041)和肾功能稳定(估计肾小球滤过率改善4.1%,而MMF组下降5.3%,P = 0.085)。与MMF +低剂量类固醇相比,Telitacicept +低剂量类固醇获得更高的完全缓解率(33.3%对16.1%,P = 0.04)和显著更低的无缓解率(29.2%对48.2%,P = 0.048)。累积缓解率(完全+部分)在所有时间点都有利于telitacicept,在12个月时差异最大。值得注意的是,telitacicept所需的累积糖皮质激素剂量显著降低(P P = 0.032),且无严重并发症报道。多变量分析表明,telitacicept与达到12个月完全缓解的可能性较高相关[校正风险比6(95%可信区间1.41-25.62)]。结论:与MMF相比,Telitacicept在降低高风险IgAN患者的蛋白尿方面可能具有更好的疗效,同时降低糖皮质激素的联合需求,并显示出更有利的安全性。这些优势使其成为一种有前景的治疗选择,需要进一步的随机验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Telitacicept versus mycophenolate mofetil in IgA nephropathy: a real-world comparative study of efficacy, renal outcomes and safety.

Telitacicept versus mycophenolate mofetil in IgA nephropathy: a real-world comparative study of efficacy, renal outcomes and safety.

Telitacicept versus mycophenolate mofetil in IgA nephropathy: a real-world comparative study of efficacy, renal outcomes and safety.

Telitacicept versus mycophenolate mofetil in IgA nephropathy: a real-world comparative study of efficacy, renal outcomes and safety.

Background: This study aimed to evaluate the efficacy and safety of telitacicept versus mycophenolate mofetil (MMF) in high-risk progressive immunoglobulin A nephropathy (IgAN).

Methods: This retrospective, multicentre cohort study included patients with high-risk progressive IgAN who received telitacicept or MMF therapy, both combined with low-dose steroids. Clinical data were collected from treatment initiation to 12 months.

Results: A total of 104 patients were included, with 56 receiving MMF and 48 receiving telitacicept. The average age was 36.9 ± 11.8 years. Baseline characteristics were well balanced between groups, except for serum albumin, uric acid and tubular pathology based on the Oxford classification, which showed significant differences. At 12 months, telitacicept plus low-dose steroids demonstrated superior proteinuria reduction (-62.5% versus -52.9%, P = .041) and stabilized renal function (4.1% improvement in estimated glomerular filtration rate versus 5.3% decline with MMF, P = .085). Telitacicept plus low-dose steroids achieved higher complete remission rates (33.3% versus 16.1%; P = .04) and significantly lower non-response rates (29.2% versus 48.2%, P = .048) compared with MMF plus low-dose steroids. Cumulative remission rates (complete + partial) favoured telitacicept at all time points, with the largest difference at 12 months. Notably, telitacicept required substantially lower cumulative glucocorticoid doses (P < .001) and exhibited a superior safety profile, with significantly fewer adverse events (22.9% versus 42.9%, P = .032) and no serious complications reported. Multivariable analysis indicated telitacicept was associated with a higher likelihood of achieving 12-month complete remission [adjusted hazard ratio 6 (95% confidence interval 1.41-25.62).

Conclusions: Telitacicept may offer better efficacy compared with MMF for proteinuria reduction in high-risk IgAN patients, while reducing combined glucocorticoid requirements and demonstrating a more favourable safety profile. These advantages position it as a promising therapeutic option, warranting further randomized validation.

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来源期刊
Clinical Kidney Journal
Clinical Kidney Journal Medicine-Transplantation
CiteScore
6.70
自引率
10.90%
发文量
242
审稿时长
8 weeks
期刊介绍: About the Journal Clinical Kidney Journal: Clinical and Translational Nephrology (ckj), an official journal of the ERA-EDTA (European Renal Association-European Dialysis and Transplant Association), is a fully open access, online only journal publishing bimonthly. The journal is an essential educational and training resource integrating clinical, translational and educational research into clinical practice. ckj aims to contribute to a translational research culture among nephrologists and kidney pathologists that helps close the gap between basic researchers and practicing clinicians and promote sorely needed innovation in the Nephrology field. All research articles in this journal have undergone peer review.
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