Evaluation of Treatment Interval Extension and Short-Term Interval Stability after Switching to Faricimab in Neovascular AMD: A Mid-Term Observational Study.

IF 2.3 4区 医学 Q2 OPHTHALMOLOGY
Benjamin Simond, Inès Fenniri, Nicolas Chirpaz, Sandra Elbany, Antonin Rocher, Christelle Gilli, Samuel Chacun, Nicolas Voirin, Carole Burillon, Benjamin Matagrin, Corinne Dot
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引用次数: 0

Abstract

Introduction: The SHIFT-HB study (SwitcH Faricimab Treatment in High Burden patients) aimed to evaluate the anatomical and functional outcomes - and the short-term stability of extended dosing intervals - after switching to faricimab in high treatment burden (HB) neovascular age-related macular degeneration (nAMD) previously treated with first-generation anti-VEGF agents. The primary aim was to assess treatment interval changes after 6 intravitreal injections (IVIs) and the stability of interval gains between the 5th and 6th faricimab IVI.

Methods: Single-center, retrospective real-world study (November 2023-November 2024; tertiary center Edouard Herriot Hospital, Lyon). Eligible eyes had nAMD requiring ≤8-week intervals despite ≥6 prior aflibercept or ranibizumab injections. After the switch, all eyes received ≥6 faricimab IVIs under a proactive Treat-and-Extend regimen. Short-term stability was defined, among eyes with any interval gain, as a prescribed interval at V6 identical to or longer than that at realized at V5.

Results: In total, 190 eyes from 158 patients (mean age 81 ± 7.5 years; 57.9% female) were included. The mean pre-switch interval was 4.9 ± 1.2 weeks and increased to 6.7 weeks after 6 faricimab IVIs (p = 5.85 × 10-20). Interval increased in 61.6% of eyes; among these, 45% gained ≥3 weeks (range +3 to +8). Short-term stability between V5 and V6 occurred in 82.3% of responders. The maximum interval was first achieved at V6 in 52.1% of responder eyes. Among eyes with paired baseline and V6 measurements, best-corrected visual acuity remained stable (69.2 vs. 71.2 ETDRS letters; p = 0.67), while central retinal thickness decreased (303.1 µm-287.2 µm; p = 9.98 × 10-4). Intraocular inflammation occurred in 7 eyes (3.7%; 0.61% of injections) and led to drug discontinuation.

Conclusion: In real-world HB nAMD, switching to faricimab enabled a significant extension of injection intervals in nearly two-thirds of eyes while maintaining vision and improving OCT anatomy, supporting faricimab as a strategy to reduce treatment burden in this difficult-to-treat population.

新血管性AMD改用法昔单抗后治疗间隔延长和短期稳定性的评估,一项中期观察研究。
SHIFT-HB研究(SwitcH Faricimab治疗高负担患者)旨在评估在高治疗负担(HB)新生血管性年龄相关性黄斑变性(nAMD)之前使用第一代抗vegf药物治疗后改用Faricimab治疗后的解剖和功能结果以及延长给药间隔的短期稳定性。主要目的是评估6次玻璃体内注射(IVI)后的治疗间隔变化以及第5次和第6次法利昔单抗IVI之间间隔增益的持久性。方法:单中心、回顾性现实世界研究(2023年11月- 2024年11月;里昂爱德华·赫里奥医院三级中心)。尽管既往注射阿非利塞普或雷尼单抗≥6次,但符合条件的眼睛仍需要≤8周的nAMD间隔。转换后,所有的眼睛在积极的治疗和延长方案下接受≥6次法利西单抗iv。在具有任何间隔增益的眼睛中,短期稳定性被定义为在V6处的规定间隔等于或长于在V5处实现的间隔。结果:纳入158例患者190只眼(平均年龄81±7.5岁,女性57.9%)。平均转换前间隔为4.9±1.2周,6次法昔单抗注射后增加到6.7周(p=5.85 × 10-20)。61.6%的眼睛间隔增加;其中45%的患者生存≥3周(+3 ~ +8)。82.3%的应答者出现V5和V6之间的短期稳定性。52.1%的应答眼在V6时首次达到最大间隔。在基线和V6测量值配对的眼睛中,最佳矫正视力保持稳定(69.2 vs 71.2 ETDRS字母;p=0.67),而视网膜中央厚度(CRT)下降(303.1 µm至287.2 µm; p=9.98x10-4)。7只眼发生眼内炎症(3.7%;0.61%)并导致停药。结论:在现实世界的HB nAMD中,改用法利西单抗可以显著延长近三分之二眼睛的注射间隔,同时保持视力并改善OCT解剖,支持法利西单抗作为减轻这一难以治疗人群治疗负担的策略。
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来源期刊
Ophthalmologica
Ophthalmologica 医学-眼科学
CiteScore
5.10
自引率
3.80%
发文量
39
审稿时长
3 months
期刊介绍: Published since 1899, ''Ophthalmologica'' has become a frequently cited guide to international work in clinical and experimental ophthalmology. It contains a selection of patient-oriented contributions covering the etiology of eye diseases, diagnostic techniques, and advances in medical and surgical treatment. Straightforward, factual reporting provides both interesting and useful reading. In addition to original papers, ''Ophthalmologica'' features regularly timely reviews in an effort to keep the reader well informed and updated. The large international circulation of this journal reflects its importance.
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