Nichani Prem A H, Popovic Marko M, Mihalache Andrew, Pathak Ananya, Muni Rajeev H, Wong David T W, Kertes Peter J
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada,
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.
Ophthalmologica. 2024;247(5-6):355-372. doi: 10.1159/000541662. Epub 2024 Oct 3.
Intravitreal anti-vascular endothelial growth factor (VEGF) therapy has become the mainstay of treatment in many retinal diseases. The comparative efficacy and safety of newer bispecific anti-VEGF/angiopoietin 2 (Ang2) agents in the treatment paradigm versus widely used monospecific anti-VEGF agents remains unclear.
A systematic literature search of MEDLINE, Embase, and Cochrane Library was conducted to identify comparative observational studies and randomized controlled trials published from 2015 to Jul 2024. With assessment by three independent reviewers, original English peer-reviewed full-text articles evaluating faricimab versus monospecific anti-VEGF agent(s) in FDA-indicated retinal disease with data on at least one set of efficacy and/or safety outcomes for each treatment arm and a minimum 3-month follow-up period were included. Data were appraised using the Cochrane RoB2 and ROBINS-I tools, PRISMA, and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) guidelines. All outcomes were collected at the last follow-up. Random effects meta-analyses with 95% confidence intervals were conducted to calculate weighted mean differences and risk ratios. Change in best-corrected visual acuity (BCVA, ETDRS letters), change in central subfield thickness (CSFT, μm), and presence of retinal fluid were primary endpoints; ocular adverse events were secondary endpoints.
Across 13 studies, in the context of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO), 2,226 eyes received anti-VEGF monotherapy and 3,022 received faricimab. Final and change in BCVA were similar between treatment groups. Faricimab was associated with a significantly higher reduction in CSFT in DME and RVO eyes but not in nAMD eyes. The incidence of ocular adverse events was similar between groups.
There was no difference in BCVA between faricimab and anti-VEGF monotherapy in nAMD, DME, and RVO. While faricimab offered superior improvement in CSFT at the final follow-up for DME and RVO eyes, this effect was not seen in nAMD eyes. Future studies are needed to establish the long-term safety and efficacy of faricimab for retinal vascular disease.
玻璃体内抗血管内皮生长因子（VEGF）疗法已成为许多视网膜疾病治疗的主要手段。新型双特异性抗VEGF/血管生成素2（Ang2）药物与广泛使用的单特异性抗VEGF药物相比，在治疗模式中的疗效和安全性仍不明确。
对MEDLINE、Embase和Cochrane图书馆进行系统文献检索，以识别2015年至2024年7月发表的比较观察性研究和随机对照试验。由三名独立评审员进行评估，纳入原始英文同行评审全文文章，这些文章评估了法西单抗与单特异性抗VEGF药物在FDA批准的视网膜疾病中的疗效，每个治疗组至少有一组疗效和/或安全性结果数据，且随访期至少为3个月。使用Cochrane RoB2和ROBINS-I工具、PRISMA以及推荐分级、评估、制定和评价（GRADE）指南对数据进行评估。所有结果均在最后一次随访时收集。进行95%置信区间的随机效应荟萃分析，以计算加权平均差和风险比。最佳矫正视力（BCVA，ETDRS字母）的变化、中心子场厚度（CSFT，μm）的变化以及视网膜积液的存在为主要终点；眼部不良事件为次要终点。
在13项研究中，在新生血管性年龄相关性黄斑变性（nAMD）、糖尿病性黄斑水肿（DME）和视网膜静脉阻塞（RVO）的背景下，2226只眼接受了抗VEGF单药治疗，3022只眼接受了法西单抗治疗。治疗组之间的最终BCVA和BCVA变化相似。法西单抗与DME和RVO眼中CSFT的显著更大降低相关，但在nAMD眼中并非如此。两组之间眼部不良事件的发生率相似。
在nAMD、DME和RVO中，法西单抗与抗VEGF单药治疗在BCVA方面没有差异。虽然法西单抗在DME和RVO眼的最后一次随访中CSFT有更好的改善，但在nAMD眼中未观察到这种效果。需要进一步的研究来确定法西单抗治疗视网膜血管疾病的长期安全性和疗效。
