目的:评价法立单抗与其他抗血管内皮生长因子(抗VEGF)药物治疗新生血管性年龄相关性黄斑变性(nAMD)的疗效和安全性。
方法:到2023年1月进行了系统评价(SR)。进行了网络荟萃分析(NMA),包括对幼稚人群的敏感性和亚组分析。结果包括视力变化(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。Cochrane协作指南和网络元分析框架的可信度用于SR和证据的确定性,分别。
结果:通过电子数据库和互补搜索,从4128条确定的记录中,63项随机对照试验(RCT)符合资格标准,42包括在NMA中。与大多数固定和灵活的抗VEGF治疗方案相比,Faricimab的年度注射次数显着减少,虽然通过ETDRS字母增益显示视力没有统计学上的显著差异,表现出相当的功效。视网膜厚度结果显示与其他抗VEGF药物的疗效相当,仅次于布鲁单抗。结果还显示,每8周,与阿柏西普相比,使用法利单抗治疗的患者更多的患者没有治疗后的视网膜液,雷珠单抗和贝伐单抗,在固定和亲瑞纳塔(PRN)评估的时间表中。Faricimab在眼部不良事件和严重眼部不良事件(SOAE)的风险方面表现出相当的安全性,除了与Brolucizumab的季度比较,其中faricimab显示SOAE风险显着降低。
结论:Faricimab在疗效和安全性方面显示出相当的临床益处,与固定和灵活的抗VEGF药物方案相比,每年注射量减少,代表nAMD患者的有价值的治疗选择。
■CRD42023394226。
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: 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.
CONCLUSIONS: 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.
UNASSIGNED: CRD42023394226.