Ziyan Ding, Hui Zhang, Fan Huang, Yian Liu, Qian Zhou, Dingyuan Hu, Liming Chen, Yanting Li, Rui Ding, Xiaoyan Nie, Yi Fang
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引用次数: 0
Abstract
Objectives: This study aimed to use Bayesian network meta-analysis to compare the efficacy and safety of biologics for systemic lupus erythematosus (SLE). A comprehensive and systematic search of electronic databases (PubMed, Medline, Cochrane Library, EMBASE, Web of Science, CNKI, and WanFang Data) was conducted from 2014 to September 2024. Our study only included randomized controlled trials with full articles that enrolled adult SLE patients treated with biologics, in comparison with standard therapy. The primary efficacy endpoints were SLE Responder Index 4 (SRI4) and BICLA (BILAG-Based Composite Lupus Assessment). The safety endpoints were adverse events (AEs) and serious adverse events (SAEs). R 4.4.3 and RStudio were used to conduct the network meta-analysis. RevMan 5.4 was used to assess the included literature. 29 randomized controlled trials with a total of 13,712 patients met the inclusion criteria. The network meta-analysis indicated that compared with standard therapy, telitacicept (OR 5.2, 95% CI 1.4-20.0) demonstrated superior efficacy in achieving SRI4 response, deucravacitinib (OR 1.6, 95% CI 1.0-2.5), and anifrolumab (OR 1.6, 95% CI 1.3-2.0) all exhibited significant BICLA response in moderate-to-severe SLE patients. Regarding safety, it was observed that there were no significant statistical differences among the various treatment options. Cluster analysis revealed that deucravacitinib exhibited the best efficacy-safety profile. Deucravacitinib suggested a favorable profile between efficacy and safety. Telitacicept showed the most pronounced improvement in SRI-4 response, but was associated with higher rates of AEs and SAEs, whereas anifrolumab and deucravacitinib displayed advantages in reducing SAEs. For patients with elevated baseline IFN signatures, anti-type I interferon biologics such as anifrolumab and sifalimumab are recommended to maximize clinical benefits. The reliance on indirect comparisons necessitates cautious interpretation of these findings, so further research should prioritize direct head-to-head trials to validate the efficacy and safety profiles of these biologics.
目的:本研究旨在利用贝叶斯网络荟萃分析比较生物制剂治疗系统性红斑狼疮(SLE)的疗效和安全性。从2014年到2024年9月,对PubMed、Medline、Cochrane Library、EMBASE、Web of Science、CNKI、万方数据等电子数据库进行了全面系统的检索。我们的研究只纳入了随机对照试验,纳入了接受生物制剂治疗的成年SLE患者,并与标准治疗进行了比较。主要疗效终点为SLE应答者指数4 (SRI4)和BICLA(基于bilag的狼疮综合评估)。安全性终点为不良事件(ae)和严重不良事件(sae)。使用r4.4.3和RStudio进行网络meta分析。采用RevMan 5.4对纳入的文献进行评估。29项随机对照试验共13712例患者符合纳入标准。网络荟萃分析显示,与标准治疗相比,替利他塞普(OR 5.2, 95% CI 1.4-20.0)在实现SRI4应答方面表现出更优的疗效,deucravacitinib (OR 1.6, 95% CI 1.0-2.5)和anifrolumab (OR 1.6, 95% CI 1.3-2.0)在中重度SLE患者中均表现出显著的BICLA应答。关于安全性,我们观察到不同治疗方案之间没有显著的统计学差异。聚类分析显示,deucravacitinib具有最佳的疗效和安全性。Deucravacitinib在疗效和安全性方面表现良好。Telitacicept对SRI-4反应的改善最为明显,但与ae和SAEs的发生率较高相关,而anfrolumab和deucravacitinib在减少SAEs方面表现出优势。对于基线IFN信号升高的患者,推荐使用抗I型干扰素生物制剂,如anfrolumab和sifalimumab,以最大限度地提高临床疗效。对间接比较的依赖需要对这些发现进行谨慎的解释,因此进一步的研究应优先考虑直接的正面试验,以验证这些生物制剂的有效性和安全性。
期刊介绍:
Clinical Reviews in Allergy & Immunology is a scholarly journal that focuses on the advancement of clinical management in allergic and immunologic diseases. The journal publishes both scholarly reviews and experimental papers that address the current state of managing these diseases, placing new data into perspective. Each issue of the journal is dedicated to a specific theme of critical importance to allergists and immunologists, aiming to provide a comprehensive understanding of the subject matter for a wide readership.
The journal is particularly helpful in explaining how novel data impacts clinical management, along with advancements such as standardized protocols for allergy skin testing and challenge procedures, as well as improved understanding of cell biology. Ultimately, the journal aims to contribute to the improvement of care and management for patients with immune-mediated diseases.