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玻璃体内 faricimab 治疗新生血管性年龄相关性黄斑变性的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of intravitreal faricimab for neovascular age-related macular degeneration: a systematic review and meta-analysis.

机构信息

Department of Ophthalmology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.

Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.

出版信息

Sci Rep. 2024 Jan 30;14(1):2485. doi: 10.1038/s41598-024-52942-3.

Abstract

We conducted a systematic review and meta-analysis to evaluate the visual, anatomical, and safety outcomes of the intravitreal faricimab, a novel vascular endothelial growth factor (VEGF)/angiopoietin-2 (Ang-2) bispecific agent, in neovascular age-related macular degeneration (nAMD) patients. The follow-up times in the included studies ranged from a minimum of 36 weeks to a maximum of 52 weeks. EMBASE, Ovid-Medline, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, Scopus, the WHO ICTRP, ClinicalTrial.gov, the EU Clinical Trials Register, and Chinese Clinical Trial Registry (ChiCTR) were searched (The last literature search was performed on August 17, 2023) for randomized controlled trials (RCTs) comparing faricimab with control groups for neovascular age-related macular degeneration (nAMD). The risk of bias for eligible RCTs was independently assessed using the Cochrane Risk of Bias Tool by two authors (W.-T.Y. and C.-S.W.). The meta-analysis was conducted using Review Manager 5.4 software. The mean best corrected visual acuity (BCVA), central subfield thickness (CST), total choroidal neovascularization (CNV) area, and total lesion leakage were analyzed as continuous variables and the outcome measurements were reported as the weighted mean difference (WMD) with a 95% confidence interval (CI). The ocular adverse events and ocular serious adverse events were analyzed as dichotomous variables and the outcome measurements were analyzed as the odds ratios (ORs) with a 95% CI. Random-effects model was used in our study for all outcome synthesizing due to different clinical characteristics. Four RCTs with 1,486 patients were eligible for quantitative analysis. There was no statistically significant difference between intravitreal faricimab and anti-VEGF in BCVA [weighted mean difference (WMD) = 0.47; 95% CI: (- 0.17, 1.11)]. The intravitreal faricimab group showed numerically lower CST [WMD =  - 5.96; 95% CI = (- 7.11, - 4.82)], total CNV area [WMD =  - 0.49; 95% CI = (- 0.68, - 0.30)], and total lesion leakage [WMD =  - 0.88; 95% CI = (- 1.08, - 0.69)] after intravitreal therapy compared with the intravitreal anti-VEGF group. There were no statistically significant differences between intravitreal faricimab and anti-VEGF in ocular adverse events (AEs) [pooled odds ratio (OR) = 1.10; 95% CI = (0.81, 1.49)] and serious adverse events (SAEs) [pooled OR = 0.84; 95% CI = (0.37, 1.90)]. The intravitreal bispecific anti-VEGF/angiopoietin 2 (Ang2) antibody faricimab with a extended injection interval was non-inferior to first-line anti-VEGF agents in BCVA. It was safe and had better anatomical recovery. Large, well-designed RCTs are needed to explore the potential benefit of extended faricimab for nAMD. This systematic review was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD42022327450).

摘要

我们进行了一项系统评价和荟萃分析,以评估新型血管内皮生长因子(VEGF)/血管生成素-2(Ang-2)双特异性药物玻璃体腔内 faricimab 对新生血管性年龄相关性黄斑变性(nAMD)患者的视力、解剖和安全性结局。纳入研究的随访时间从最短的 36 周到最长的 52 周不等。EMBASE、Ovid-Medline、Cochrane 对照试验中心注册库(CENTRAL)、Web of Science、Scopus、世界卫生组织国际临床试验注册平台(WHO ICTRP)、ClinicalTrials.gov、欧盟临床试验注册库和中国临床试验注册中心(ChiCTR)(最后一次文献检索于 2023 年 8 月 17 日进行)对比较 faricimab 与对照组治疗 nAMD 的随机对照试验(RCT)进行了检索。两名作者(W.-T.Y.和 C.-S.W.)独立使用 Cochrane 偏倚风险工具评估了合格 RCT 的偏倚风险。使用 Review Manager 5.4 软件进行荟萃分析。平均最佳矫正视力(BCVA)、中心视网膜下厚度(CST)、总脉络膜新生血管(CNV)面积和总病变渗漏作为连续变量进行分析,结果测量值报告为加权均数差(WMD)及其 95%置信区间(CI)。眼不良事件和眼严重不良事件作为二分类变量进行分析,结果测量值分析为比值比(OR)及其 95%置信区间(CI)。由于不同的临床特征,我们的研究使用了随机效应模型对所有结局进行综合。四项纳入 1486 名患者的 RCT 进行了定量分析。玻璃体内 faricimab 与抗 VEGF 治疗在 BCVA 方面无统计学差异[加权均数差(WMD)=0.47;95%CI:(-0.17,1.11)]。玻璃体内 faricimab 组 CST [WMD=-5.96;95%CI=-7.11,-4.82]、总 CNV 面积[WMD=-0.49;95%CI=-0.68,-0.30]和总病变渗漏[WMD=-0.88;95%CI=-1.08,-0.69]均低于玻璃体内抗 VEGF 组,但无统计学差异。玻璃体内 faricimab 与抗 VEGF 在眼不良事件(AEs)[汇总比值比(OR)=1.10;95%CI:(0.81,1.49)]和严重不良事件(SAEs)[汇总 OR=0.84;95%CI:(0.37,1.90)]方面无统计学差异。延长注射间隔的玻璃体腔内双特异性抗 VEGF/血管生成素 2(Ang2)抗体 faricimab 在 BCVA 方面与一线抗 VEGF 药物相当。它是安全的,具有更好的解剖学恢复。需要进行大型、精心设计的 RCT 来探索 faricimab 对 nAMD 的潜在益处。本系统评价已在国际前瞻性系统评价注册库(PROSPERO)数据库(CRD42022327450)中进行了注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39e9/10827713/e10c68fb98eb/41598_2024_52942_Fig1_HTML.jpg

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