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Abstract：
BACKGROUND: This review aims to assess the efficacy, durability and safety of faricimab-a dual vascular endothelial growth factor and angiopoietin 2 inhibitor-in patients with neovascular age-related macular degeneration (nAMD) and diabetic macula oedema (DMO). It summarises the findings of current studies on faricimab and discusses whether this new drug may fill a gap in current treatment options.
METHODS: We performed a search of the PubMed, Cochrane, Web of Science and EMBASE databases for publications on faricimab between 29 November 2022 and 10 May 2023, and a search of ClinicalTrials.gov for the protocols on clinical trials for this review. We included clinical trials, case-control studies and observational studies.
RESULTS: In phase 3 trials of nAMD, the efficacy of faricimab was non-inferior to aflibercept (+ 5.8-6.6 vs. + 5.1-6.6 Early Treatment Diabetic Retinopathy Study [ETDRS] letters). At study end, 80% of faricimab-treated patients were on ≥ 12-week dosing intervals, and 44.9-45.7% of faricimab-treated patients were on 16-week dosing intervals. Total adverse events, as well as serious ocular adverse events, were comparable between groups. In phase 3 trials of DMO, efficacy of faricimab was non-inferior to aflibercept (+ 10.7-11.8 vs. + 10.3-10.9 ETDRS letters). At study end, > 70% of patients in the personalised treatment interval faricimab group were on ≥ 12-week dosing intervals, and 51-53% were on 16-week dosing intervals. Total adverse events were comparable between groups, although the rate of serious ocular adverse events was higher in the faricimab groups than in the aflibercept groups (1.9-3.1% vs. 0.6-1.9%, respectively). In real-world studies of treatment-resistant nAMD or DMO, faricimab demonstrated superior efficacy compared to aflibercept. In a real-world study of mostly previously treated nAMD, faricimab demonstrated some efficacy.
CONCLUSIONS: Faricimab demonstrated non-inferior to superior efficacy, strong durability and acceptable safety in treatment-naïve nAMD and mostly treatment-naïve DMO, as well as superior efficacy in treatment-resistant nAMD and DMO. However, further research is needed on faricimab in real-world settings.
METHODS: We performed a search of the PubMed, Cochrane, Web of Science and EMBASE databases for publications on faricimab between 29 November 2022 and 10 May 2023, and a search of ClinicalTrials.gov for the protocols on clinical trials for this review. We included clinical trials, case-control studies and observational studies.
RESULTS: In phase 3 trials of nAMD, the efficacy of faricimab was non-inferior to aflibercept (+ 5.8-6.6 vs. + 5.1-6.6 Early Treatment Diabetic Retinopathy Study [ETDRS] letters). At study end, 80% of faricimab-treated patients were on ≥ 12-week dosing intervals, and 44.9-45.7% of faricimab-treated patients were on 16-week dosing intervals. Total adverse events, as well as serious ocular adverse events, were comparable between groups. In phase 3 trials of DMO, efficacy of faricimab was non-inferior to aflibercept (+ 10.7-11.8 vs. + 10.3-10.9 ETDRS letters). At study end, > 70% of patients in the personalised treatment interval faricimab group were on ≥ 12-week dosing intervals, and 51-53% were on 16-week dosing intervals. Total adverse events were comparable between groups, although the rate of serious ocular adverse events was higher in the faricimab groups than in the aflibercept groups (1.9-3.1% vs. 0.6-1.9%, respectively). In real-world studies of treatment-resistant nAMD or DMO, faricimab demonstrated superior efficacy compared to aflibercept. In a real-world study of mostly previously treated nAMD, faricimab demonstrated some efficacy.
CONCLUSIONS: Faricimab demonstrated non-inferior to superior efficacy, strong durability and acceptable safety in treatment-naïve nAMD and mostly treatment-naïve DMO, as well as superior efficacy in treatment-resistant nAMD and DMO. However, further research is needed on faricimab in real-world settings.
摘要：
背景：这篇综述旨在评估疗效，Faricimab-一种血管内皮生长因子和血管生成素2双重抑制剂-在新生血管性年龄相关性黄斑变性(nAMD)和糖尿病性黄斑水肿(DMO)患者中的耐久性和安全性。它总结了目前关于法利单抗的研究结果，并讨论了这种新药是否可以填补目前治疗方案的空白。
方法：我们搜索了PubMed，科克伦,WebofScience和EMBASE数据库，用于2022年11月29日至2023年5月10日之间有关faricimab的出版物，并搜索ClinicalTrials.gov，以了解本次审查的临床试验方案。我们包括临床试验，病例对照研究和观察性研究。
结果：在nAMD的3期试验中，法利单抗的疗效不劣于阿柏西普（5.8-6.6vs.+5.1-6.6早期治疗糖尿病视网膜病变研究[ETDRS]字母）。在研究结束时，80%的法利单抗治疗患者的给药间隔≥12周，44.9-45.7%的法利单抗治疗患者间隔给药16周。总不良事件,以及严重的眼部不良事件，组间具有可比性。在DMO的第三阶段试验中，法利单抗的疗效不劣于阿柏西普（10.7-11.8vs.+10.3-10.9ETDRS字母）。在研究结束时，>70％的患者在个性化治疗间隔法利单抗组≥12周的给药间隔，51-53%的患者间隔为16周。两组之间的总不良事件具有可比性，尽管法利单抗组的严重眼部不良事件发生率高于阿柏西普组（1.9-3.1％vs.0.6-1.9%，分别)。在对治疗抗性nAMD或DMO的实际研究中，与阿柏西普相比，法利克单抗表现出更好的疗效。在一项对大部分以前治疗过的nAMD的现实世界研究中，法利克单抗表现出一定的疗效。
结论：Faricimab表现出不亚于优越的疗效，强大的耐久性和可接受的安全性在治疗-天真的nAMD和主要是治疗-天真的DMO，以及在治疗耐药nAMD和DMO中的优异疗效。然而,在现实世界中需要对faricimab进行进一步的研究。
方法：我们搜索了PubMed，科克伦,WebofScience和EMBASE数据库，用于2022年11月29日至2023年5月10日之间有关faricimab的出版物，并搜索ClinicalTrials.gov，以了解本次审查的临床试验方案。我们包括临床试验，病例对照研究和观察性研究。
结果：在nAMD的3期试验中，法利单抗的疗效不劣于阿柏西普（5.8-6.6vs.+5.1-6.6早期治疗糖尿病视网膜病变研究[ETDRS]字母）。在研究结束时，80%的法利单抗治疗患者的给药间隔≥12周，44.9-45.7%的法利单抗治疗患者间隔给药16周。总不良事件,以及严重的眼部不良事件，组间具有可比性。在DMO的第三阶段试验中，法利单抗的疗效不劣于阿柏西普（10.7-11.8vs.+10.3-10.9ETDRS字母）。在研究结束时，>70％的患者在个性化治疗间隔法利单抗组≥12周的给药间隔，51-53%的患者间隔为16周。两组之间的总不良事件具有可比性，尽管法利单抗组的严重眼部不良事件发生率高于阿柏西普组（1.9-3.1％vs.0.6-1.9%，分别)。在对治疗抗性nAMD或DMO的实际研究中，与阿柏西普相比，法利克单抗表现出更好的疗效。在一项对大部分以前治疗过的nAMD的现实世界研究中，法利克单抗表现出一定的疗效。
结论：Faricimab表现出不亚于优越的疗效，强大的耐久性和可接受的安全性在治疗-天真的nAMD和主要是治疗-天真的DMO，以及在治疗耐药nAMD和DMO中的优异疗效。然而,在现实世界中需要对faricimab进行进一步的研究。
