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IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology science Pub Date : 2025-02-21 DOI:10.1016/j.xops.2025.100744

Varun Chaudhary MD, MSc , Robyn Guymer MBBS, PhD , Audrey Artignan MPhil , Amanda Downey PhD, MBA , Rishi P. Singh MD

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引用次数: 0

摘要

目的自从法尼单抗（Vabysmo）被批准用于治疗新生血管性年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）以来，越来越多的真实世界数据被报道出来，成为法尼单抗在异质性人群中的重要证据来源。范围界定综述是一种有效的方法，可用于全面评估尚未充分定性的领域的证据状况，并可纳入各种研究设计和方法。本范围界定综述旨在评估法尼单抗当前真实世界证据（RWE）的广度和性质，并描述其在常规临床实践中的安全性和有效性。方法于2024年2月16日检索了MEDLINE、Embase和Cochrane系统综述数据库，并由2位独立审稿人对结果进行了审查。此外，还对主要相关会议的论文集、ClinicalTrials.gov 和相关系统文献综述的书目进行了人工检索。结果共发现 63 项研究报告了法尼单抗在 nAMD 或 DME 患者（n = 6-12 119 眼）中的 RWE，其中大部分研究是针对既往接受过治疗的患者。研究横跨 10 个国家，以回顾性观察研究为主。大多数研究结果表明，即使研究时间较长（≥6 个月），法尼单抗也能改善视力、降低中央脉络膜/黄斑下野厚度、减少/缓解两种情况下的视网膜积液和色素上皮脱落。结论法尼单抗在常规治疗中的结果与临床试验报告一致，支持法尼单抗在不同人群中的有效性和安全性。需要进一步开展采用前瞻性多中心设计的高质量研究，以便更全面地了解法尼单抗的长期疗效。

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Real-World Evidence for Faricimab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: A Scoping Review

Purpose

Since faricimab (Vabysmo) was approved for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), a growing body of real-world data has been reported, forming an important source of evidence for faricimab in a heterogeneous population. Scoping reviews are an effective approach to comprehensively assess the state of evidence on areas yet to be well characterized, allowing for the inclusion of a wide range of study designs and methodologies. This scoping review aimed to assess the current breadth and nature of real-world evidence (RWE) for faricimab and describe its safety and effectiveness in routine clinical practice.

Design

Scoping review of published articles and grey literature.

Participants

Eligible records included primary research reporting on any real-world data from ≥5 participants treated with faricimab in its licensed indications, published in English since 2022. This review did not involve novel data collection in human participants.

Methods

MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched on February 16, 2024, and the results were reviewed by 2 independent reviewers. Manual searches of proceedings from major relevant conferences, ClinicalTrials.gov, and bibliographies of relevant systematic literature reviews were also conducted. Findings were summarized descriptively.

Main Outcome Measures

Data of interest included study design, population characteristics, treatment history, visual function and anatomic outcomes, patient-reported outcomes, safety, and economic outcomes.

Results

A total of 63 studies reporting RWE for faricimab in patients with nAMD or DME (n = 6–12 119 eyes) were identified, including a majority of studies in previously treated patients. Studies spanned 10 countries, with a predominance of retrospective observational studies. Results across the majority of studies suggested that faricimab was associated with improved visual acuity, reduced central choroidal/subfield macular thickness, and reduced/resolved retinal fluid and pigment epithelial detachment in both conditions, even over longer study periods (≥6 months). Adverse events reported were similar to the findings within the registration trials.

Conclusions

Outcomes of faricimab in routine practice align with reports from clinical trials, supporting the effectiveness and safety of faricimab in heterogeneous populations. Further high-quality studies using prospective, multicenter designs are required to provide a more comprehensive understanding of the long-term outcomes associated with faricimab.