法尼单抗治疗新生血管性老年黄斑变性的有效性和安全性:系统综述和网络荟萃分析。

IF 2 Q2 OPHTHALMOLOGY
Daniel Samacá-Samacá, Claudia Hernández-Castillo, Laura Prieto-Pinto, Francisco Rodríguez, Carolina Sardi, Hugo Ocampo, Joshua Kock, Fabián Hernández
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引用次数: 0

摘要

目的评估法尼单抗与其他抗血管内皮生长因子(anti-VEGF)药物治疗新生血管性老年性黄斑变性(nAMD)患者的疗效和安全性:截至2023年1月进行了一项系统综述(SR)。进行了网络荟萃分析 (NMA),包括针对新患者的敏感性分析和亚组分析。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。在SR和证据确定性方面分别采用了Cochrane协作指南和网络Meta分析框架:通过电子数据库和补充检索确定了4128条记录,其中63项随机对照试验(RCT)符合资格标准,42项纳入了NMA。与大多数固定和灵活的抗血管内皮生长因子治疗方案相比,法利珠单抗可显著减少每年的注射次数,而通过ETDRS字母增益计算的视力差异无统计学意义,证明疗效相当。视网膜厚度结果显示,其疗效与其他抗血管内皮生长因子药物相当,仅逊色于布卢单抗。结果还显示,与每8周一次的阿夫利百普、雷尼珠单抗和贝伐珠单抗相比,在固定和临时(PRN)评估计划中,更多接受法利单抗治疗的患者在治疗后没有视网膜积液。在眼部不良事件和严重眼部不良事件(SOAE)的风险方面,法利单抗显示出了可比的安全性,但与每季度一次的brolucizumab相比,法利单抗的SOAE风险显著降低:结论:与固定和灵活的抗血管内皮生长因子药物治疗方案相比,法利珠单抗在疗效和安全性方面显示出相当的临床获益,并减少了每年的注射次数,是nAMD患者的一种有价值的治疗选择:CRD42023394226。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of faricimab for neovascular age-related macular degeneration: a systematic review and network meta-analysis.

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.

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来源期刊
BMJ Open Ophthalmology
BMJ Open Ophthalmology OPHTHALMOLOGY-
CiteScore
3.40
自引率
4.20%
发文量
104
审稿时长
20 weeks
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