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贝利木单抗/增殖诱导配体双重抑制剂泰吉华单抗治疗IgA肾病的疗效和安全性:一项回顾性病例对照研究

Efficacy and safety of telitacicept, a BLyS/APRIL dual inhibitor, in the treatment of IgA nephropathy: a retrospective case-control study.

作者信息

Wang Meng, Ma Jianfei, Yao Li, Fan Yi

机构信息

Department of Nephrology, First Hospital of China Medical University, Shenyang, Liaoning Province, China.

出版信息

Clin Kidney J. 2024 Sep 13;17(10):sfae285. doi: 10.1093/ckj/sfae285. eCollection 2024 Oct.

DOI:10.1093/ckj/sfae285
PMID:39391591
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11464987/
Abstract

BACKGROUND

Telitacicept, a B lymphocyte stimulator/A proliferation-inducing ligand dual-target fusion protein, has recently been used in autoimmune diseases. We assessed the efficacy and safety of telitacicept in immunoglobulin A nephropathy (IgAN) patients.

METHODS

This study included 42 IgAN patients who received telitacicept treatment, forming the 'whole telitacicept group'. Among them, 20 patients who had not previously received corticosteroid (CS) therapy or immunosuppressive (IS) agents were categorized as the 'newly treated telitacicept subgroup'. Additionally, 28 patients who were selected to match historical controls received conventional IS therapy (CS therapy with/without IS agents) and were classified as the 'conventional IS group'. Telitacicept was partially used in combination with conventional IS therapy, including initial CS in different doses. Various indicators were compared at 4-week intervals up to 24 weeks among the three groups.

RESULTS

After 24 weeks of treatment, the 24-hour proteinuria decreased from 1.70 g [interquartile range (IQR) 1.05-2.58] to 0.21 g (IQR 0.39-0.13) ( = .043) in the newly treated telitacicept subgroup, from 1.78 g (IQR 0.97-2.82) to 0.44 g (IQR 1.48-0.16) ( = .001) in the conventional IS group and from 1.07 g (IQR 0.66-1.99) to 0.26 g (IQR 0.59-0.17) ( = .028) in the whole telitacicept group. The estimated glomerular filtration rate (eGFR) increased from 76.58 ± 30.26 ml/min/1.73 m to 80.30 ± 26.76 ml/min/1.73 m ( = .016) in the newly treated telitacicept subgroup, from 72.73 ± 33.41 ml/min/1.73 m to 84.08 ± 26.81 ml/min/1.73 m ( = .011) in the conventional IS group and from 70.10 ± 32.88 ml/min/1.73 m to 71.21 ± 31.49 ml/min/1.73 m ( = .065) in the whole telitacicept group. During follow-up periods, the efficacy rates of the three groups did not show statistically significant differences and no serious adverse events were observed.

CONCLUSIONS

Telitacicept may be a safe and effective treatment for IgAN, offering reductions in proteinuria and increases in eGFR similar to conventional IS therapy. After a 24-week follow-up, the incidence of adverse events was lower for telitacicept than for conventional IS therapy.

摘要

背景

泰它西普是一种B淋巴细胞刺激因子/A增殖诱导配体双靶点融合蛋白,最近已用于自身免疫性疾病。我们评估了泰它西普在免疫球蛋白A肾病(IgAN)患者中的疗效和安全性。

方法

本研究纳入42例接受泰它西普治疗的IgAN患者,组成“泰它西普全组”。其中,20例既往未接受过皮质类固醇(CS)治疗或免疫抑制剂(IS)治疗的患者被归类为“初治泰它西普亚组”。此外,选择28例患者与历史对照匹配,接受传统IS治疗(CS治疗联合/不联合IS药物),并归类为“传统IS组”。泰它西普部分与传统IS治疗联合使用,包括不同剂量的初始CS。在三组中,每隔4周比较各项指标,直至24周。

结果

治疗24周后,初治泰它西普亚组24小时蛋白尿从1.70 g[四分位间距(IQR)1.05 - 2.58]降至0.21 g(IQR 0.39 - 0.13)(P = 0.043),传统IS组从1.78 g(IQR 0.97 - 2.82)降至0.44 g(IQR 1.48 - 0.16)(P = 0.001),泰它西普全组从1.07 g(IQR 0.66 - 1.99)降至0.26 g(IQR 0.59 - 0.17)(P = 0.028)。初治泰它西普亚组估计肾小球滤过率(eGFR)从76.58 ± 30.26 ml/min/1.73 m²升至80.30 ± 26.76 ml/min/1.73 m²(P = 0.016),传统IS组从72.73 ± 33.41 ml/min/1.73 m²升至84.08 ± 26.81 ml/min/1.73 m²(P = 0.011),泰它西普全组从70.10 ± 32.88 ml/min/1.73 m²升至71.21 ± 31.49 ml/min/1.73 m²(P = 0.065)。在随访期间,三组的有效率未显示出统计学显著差异,且未观察到严重不良事件。

结论

泰它西普可能是一种治疗IgAN的安全有效方法,与传统IS治疗相似,可降低蛋白尿并提高eGFR。经过24周的随访,泰它西普的不良事件发生率低于传统IS治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/daab/11464987/7d87b7d5a4e0/sfae285fig11.jpg
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