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法替卡滨治疗新生血管性年龄相关性黄斑变性的疗效和安全性:系统评价和网络荟萃分析。

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

机构信息

Evidence Generation, Roche Colombia, Bogotá D.C, Colombia

Real World Insights, IQVIA Solutions, Bogotá D.C, Colombia.

出版信息

BMJ Open Ophthalmol. 2024 Jul 23;9(1):e001702. doi: 10.1136/bmjophth-2024-001702.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of faricimab compared with other anti-vascular endothelial growth factor (anti-VEGF) agents in treating neovascular age-related macular degeneration (nAMD) patients.

METHODS AND ANALYSIS

A systematic review (SR) was conducted up to January 2023. Network meta-analyses (NMA) were performed, including sensitivity and subgroup analyses for naïve population. Outcomes included changes in visual acuity (Early Treatment of Diabetic Retinopathy Study [ETDRS] letters), anatomical changes, frequency of injections and adverse events. The Cochrane Collaboration guidelines and the Confidence in Network Meta-Analysis framework were used for the SR and the certainty of evidence, respectively.

RESULTS

From 4128 identified records through electronic databases and complementary searches, 63 randomised controlled trials (RCTs) met the eligibility criteria, with 42 included in the NMA. Faricimab showed a significant reduction in the number of annual injections compared with most fixed and flexible anti-VEGF treatment regimens, while showing no statistically significant differences in visual acuity through ETDRS letter gain, demonstrating a comparable efficacy. Retinal thickness results showed comparable efficacy to other anti-VEGF agents, and inferior only to brolucizumab. Results also showed that more patients treated with faricimab were free from post-treatment retinal fluid compared with aflibercept every 8 weeks, and both ranibizumab and bevacizumab, in the fixed and pro re nata (PRN) assessed schedules. Faricimab showed a comparable safety profile regarding the risk of ocular adverse events and serious ocular adverse events (SOAE), except for the comparison with brolucizumab quarterly, in which faricimab showed a significant reduction for SOAE risk.

CONCLUSION

Faricimab showed a comparable clinical benefit in efficacy and safety outcomes, with a reduction in annual injections compared with fixed and flexible anti-VEGF drug regimens, representing a valuable treatment option for nAMD patients.

PROSPERO REGISTRATION NUMBER

CRD42023394226.

摘要

目的

评估 faricimab 与其他抗血管内皮生长因子(anti-VEGF)药物相比在治疗新生血管性年龄相关性黄斑变性(nAMD)患者中的疗效和安全性。

方法和分析

系统评价(SR)截至 2023 年 1 月进行。进行网络荟萃分析(NMA),包括对初治人群的敏感性和亚组分析。结局包括视力变化(糖尿病视网膜病变早期治疗研究 [ETDRS] 字母)、解剖学变化、注射频率和不良事件。使用 Cochrane 协作组指南和网络荟萃分析置信度框架分别对 SR 和证据确定性进行评估。

结果

通过电子数据库和补充搜索共确定了 4128 条记录,其中 63 项随机对照试验(RCT)符合纳入标准,其中 42 项纳入 NMA。与大多数固定和灵活的抗 VEGF 治疗方案相比,faricimab 显示出显著减少年度注射次数,而通过 ETDRS 字母增益显示视力无统计学显著差异,表明疗效相当。视网膜厚度结果显示与其他抗 VEGF 药物疗效相当,仅逊于 brolucizumab。结果还表明,与每 8 周使用 aflibercept、每固定和按需(PRN)评估方案使用 ranibizumab 和 bevacizumab相比,接受 faricimab 治疗的患者中有更多患者在治疗后没有视网膜液。faricimab 在眼部不良事件和严重眼部不良事件(SOAE)的风险方面显示出相似的安全性特征,除了与 brolucizumab 每季度比较外,faricimab 显示 SOAE 风险显著降低。

结论

faricimab 在疗效和安全性结局方面显示出相当的临床获益,与固定和灵活的抗 VEGF 药物方案相比,年度注射次数减少,为 nAMD 患者提供了一种有价值的治疗选择。

PROSPERO 注册号:CRD42023394226。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e742/11268043/6861447a001c/bmjophth-9-1-g001.jpg

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