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新型B细胞靶向生物制剂治疗系统性红斑狼疮的疗效与安全性:一项系统评价和荟萃分析

Efficacy and Safety of New B Cell-Targeted Biologic Agent for the Treatment of Systemic Lupus Erythematosus: A Systematic Review and Meta-Analysis.

作者信息

Gómez-Urquiza José L, Romero-Bejar José L, Chami-Peña Sara, Suleiman-Martos Nora, Cañadas-De la Fuente Guillermo A, Molina Esther, Riquelme-Gallego Blanca

机构信息

Faculty of Health Science, University of Granada, 51005 Ceuta, Spain.

Instituto de Investigación Biosanitaria (ibs. GRANADA), 18012 Granada, Spain.

出版信息

J Clin Med. 2023 Jul 23;12(14):4848. doi: 10.3390/jcm12144848.

Abstract

BACKGROUND

B cells are central to the pathogenesis of systemic lupus erythematosus (SLE). We aimed to analyze the efficacy and safety of new B cell-targeted drug therapies for SLE.

METHODS

A systematic review of randomized controlled trials (RCTs) and reference lists of relevant articles published from inception to 2022 were selected from PubMed, Scopus and Web of Science databases. Random effects meta-analyses were performed to estimate an overall effect size for the risk of adverse events (AEs) and serious adverse events (SAEs) with belimumab and tabalumab treatment. Heterogeneity was assessed using the I statistic and meta-regression. Funnel asymmetry was evaluated using Egger's test.

RESULTS

This study included 13 RCTs, of which three showed high risk of bias. Egger's test showed no asymmetry. The risk of SAEs and AEs was lower in the treatment group with belimumab treatment. The risk of AEs for tabalumab treatment was lower in the treatment group and lower for SAEs.

CONCLUSION

Belimumab and tabalumab therapies are effective and safe in the treatment of SLE, although tabalumab does not show sufficient statistical power. Advances in understanding the underlying mechanisms of SLE will be directed towards correlating clinical manifestations with specific pathogenic pathways and the development of precision medicine.

摘要

背景

B细胞在系统性红斑狼疮(SLE)的发病机制中起核心作用。我们旨在分析新型B细胞靶向药物疗法治疗SLE的疗效和安全性。

方法

从PubMed、Scopus和Web of Science数据库中系统检索从起始至2022年发表的随机对照试验(RCT)及相关文章的参考文献列表。采用随机效应荟萃分析来估计贝利尤单抗和他巴鲁单抗治疗的不良事件(AE)和严重不良事件(SAE)风险的总体效应量。使用I统计量和荟萃回归评估异质性。采用Egger检验评估漏斗图不对称性。

结果

本研究纳入13项RCT,其中3项显示存在高偏倚风险。Egger检验未显示不对称性。接受贝利尤单抗治疗的治疗组中SAE和AE的风险较低。接受他巴鲁单抗治疗的治疗组中AE风险较低,SAE风险也较低。

结论

贝利尤单抗和他巴鲁单抗疗法治疗SLE有效且安全,尽管他巴鲁单抗未显示出足够的统计学效力。对SLE潜在机制理解的进展将致力于将临床表现与特定致病途径相关联以及精准医学的发展。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae50/10382055/6fcbed2a7e0f/jcm-12-04848-g001.jpg

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