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.
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。