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在日本,治疗初治的新生血管性年龄相关性黄斑变性患者中 faricimab 的一年疗效和安全性评估。

One-year outcomes and safety assessment of faricimab in treatment-naïve patients with neovascular age-related macular degeneration in Japan.

机构信息

Department of Ophthalmology, Fukushima Medical University, 1 Hikarigaoka-cho, Fukushima, 960-1295, Japan.

Department of Ophthalmology, Kyorin University School of Medicine, Tokyo, Japan.

出版信息

Sci Rep. 2024 May 22;14(1):11681. doi: 10.1038/s41598-024-62559-1.

Abstract

This multicentre retrospective study evaluated the 1-year outcomes and safety profile of faricimab in treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Fifty-five patients (57 eyes) underwent loading therapy comprising three monthly faricimab injections. If dryness was achieved by the third month, subsequent treat-and-extend (TAE) follow-up continued at a minimum 8-week interval thereafter. If wet macula persisted at the third month, a fourth dose was administered, followed by the TAE regimen. After 1 year, improvements in visual acuity (0.44 ± 0.46 [baseline] to 0.34 ± 0.48; p < 0.01) and central foveal thickness (326 ± 149 [baseline] to 195 ± 82 μm; p < 0.0001) were significant. Dry macula, characterised by the absence of intraretinal or subretinal fluid, was achieved in 65% of cases. Treatment intervals varied, ranging from 8 to 16 weeks, with 44% of eyes extending to a 16-week interval, followed by 33% at 8 weeks, 16% at 12 weeks, 5% at 14 weeks, and 2% at 10 weeks. Notably, 50% of the polypoidal choroidal vasculopathy patients exhibited complete regression of polypoidal lesions between 12 and 15 months. Faricimab treatment in nAMD patients induced significant improvements in central vision and retinal morphology. Two cases of retinal pigment epithelial tears and one case of iritis were reported as ocular complications.

摘要

这项多中心回顾性研究评估了 faricimab 在治疗初治的新生血管性年龄相关性黄斑变性(nAMD)患者中的 1 年疗效和安全性。55 例患者(57 只眼)接受了负荷治疗,包括 3 个月每月一次的 faricimab 注射。如果在第 3 个月达到干燥,则此后的治疗和扩展(TAE)随访间隔至少为 8 周。如果第 3 个月时湿性黄斑仍然存在,则给予第 4 剂药物,然后开始 TAE 方案。治疗 1 年后,视力(从基线的 0.44 ± 0.46 提高到 0.34 ± 0.48;p < 0.01)和中央黄斑厚度(从基线的 326 ± 149 μm 降低到 195 ± 82 μm;p < 0.0001)均显著改善。干性黄斑(无视网膜内或视网膜下积液)的发生率为 65%。治疗间隔不同,从 8 周到 16 周不等,44%的眼延长至 16 周间隔,随后 33%延长至 8 周间隔,16%延长至 12 周间隔,5%延长至 14 周间隔,2%延长至 10 周间隔。值得注意的是,50%的息肉状脉络膜血管病变患者在 12 至 15 个月之间观察到息肉样病变完全消退。在 nAMD 患者中,faricimab 治疗可显著改善中心视力和视网膜形态。报告了 2 例视网膜色素上皮撕裂和 1 例虹膜炎作为眼部并发症。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cddd/11111667/068440af289a/41598_2024_62559_Fig1_HTML.jpg

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