改用 Faricimab 治疗强化新生血管性老年黄斑变性的真实世界一年疗效。

IF 4.4 Q1 OPHTHALMOLOGY
Ophthalmology. Retina Pub Date : 2025-01-01 Epub Date: 2024-07-30 DOI:10.1016/j.oret.2024.07.020
Sing Yue Sim, Evangelia Chalkiadaki, Georgios Koutsocheras, Luke Nicholson, Sobha Sivaprasad, Praveen J Patel, Senthil Selvam, Bishwanath Pal, Pearse A Keane, Bhairavi Bhatia, Robin Hamilton
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引用次数: 0

摘要

目的:报告改用法尼单抗治疗的强化治疗新生血管性老年性黄斑变性(nAMD)患者一年的解剖学和功能性实际结果 设计:回顾性多中心队列研究 对象:在治疗和延长方案(高治疗负担)中使用雷尼珠单抗或阿夫利百普2毫克进行4周间隔治疗的连续nAMD患者:2022年9月5日至2022年12月5日期间,在Moorfields眼科医院接受治疗和延长方案(高治疗负担)治疗的连续nAMD患者,在转用法尼单抗之前的最后三次就诊中,每4周接受一次雷尼珠单抗或阿弗利百普2毫克治疗:从电子病历中确定转用法尼单抗的 nAMD 患者总数,并纳入符合高治疗负担标准的患者。收集的数据包括切换前后视力(VA)、治疗间隔、随访时间、基线黄斑形态、中央子野厚度(CST)变化、黄斑液状态和不良事件:VA、CST、是否存在视网膜内积液(IRF)、视网膜下积液(SRF)以及改用法替单抗后一年内的注射间隔:共有 130/286 只眼球(45.5%)符合因治疗负担过重而更换治疗方案的纳入标准,其中 117 只眼球被纳入分析。在改用法替单抗之前,这些眼睛在平均 51.3±34.9 个月内接受了平均 33.4±19.6 次注射。换药前 12 个月内的平均注射次数为 10.1±1.6,前三次注射的平均间隔时间为 4.2±0.3 周。换药前的平均视力、CST 和黄斑干涩患者比例分别为 66.0±11.9 ETDRS 字母、259.6±76.0μm 和 18.3%。换药后,每次就诊后和 12 个月后的平均视力没有统计学差异。在第 3 次注射法尼单抗后和 12 个月时,平均 CST 分别减少了 20.0μm (p=0.035) 和 22.1μm (p=0.041),差异有统计学意义。平均治疗间隔延长至 6.9±2.3 周(p 结论:12个月后,既往有高治疗负担记录的nAMD患者在改用法替单抗后,视力保持不变,解剖结果也有所改善,治疗间隔延长。这类观察性研究存在固有的医生偏倚,因此建议进行前瞻性随机对照试验来验证这些发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World 1-Year Outcomes of Treatment-Intensive Neovascular Age-Related Macular Degeneration Switched to Faricimab.

Purpose: To report 1-year anatomic and functional real-world outcomes of patients with treatment-intensive neovascular age-related macular degeneration (nAMD) switched to faricimab.

Design: Retrospective multicenter cohort study.

Subjects: Consecutive nAMD patients on 4-weekly treatment interval with either ranibizumab or aflibercept 2 mg in the last 3 visits within a treat-and-extend protocol (high treatment burden) before switch to faricimab at Moorfields Eye Hospital between September 5, 2022 and December 5, 2022.

Methods: Patients with nAMD switched to faricimab were identified from electronic medical records and those who met criteria of high treatment burden were included. Data collected included preswitch and postswitch visual acuity (VA), treatment intervals, baseline macular morphology, central subfield thickness (CST), macular fluid status, and adverse events.

Main outcome measures: Visual acuity, CST, presence of intraretinal fluid, subretinal fluid, and injection intervals over 1 year after switch to faricimab.

Results: A total of 130 of 286 (45.5%) eyes met inclusion criteria of being switched due to high treatment burden and 117 were included in analysis. Before switch, these eyes received mean total number of injections of 33.4 ± 19.6 over a mean of 51.3 ± 34.9 months. Mean number of injections in 12 months preceding switch was 10.1 ± 1.6 and mean interval of the preceding 3 injections was 4.2 ± 0.3 weeks. Mean VA, CST, and percentage of patients with dry macula before switch were 66.0 ± 11.9 ETDRS letters, 259.6 ± 76.0 μm and 18.3% respectively. After switch, there was no statistical difference in mean VA throughout follow-up period. Mean CST statistically significantly reduced after the third faricimab injection and at 12 months by 20.0 μm (P = 0.035) and 22.1 μm (P = 0.041) respectively. Mean treatment intervals increased to 6.9 ± 2.3 weeks (P < 0.005) at 12 months with 42.9% and 11.4% of patients being on ≥8-weekly and ≥12-weekly treatment intervals, respectively.

Conclusions: At 12 months, nAMD patients with previous record of high treatment burden when switched to faricimab maintained VAs and improved anatomic outcomes on extended treatment intervals. Physician bias is inherent in these types of observational studies so a prospective, randomized, controlled trial is recommended to validate these findings.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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来源期刊
Ophthalmology. Retina
Ophthalmology. Retina Medicine-Ophthalmology
CiteScore
7.80
自引率
6.70%
发文量
274
审稿时长
33 days
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