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在一个新生血管性年龄相关性黄斑变性国家数据库(西班牙防治视网膜失明组织,FRB西班牙)中的布罗芦izumab临床及安全性结果

Brolucizumab clinical and safety outcomes in a neovascular age-related macular degeneration national database: Fight Retinal Blindness Spain (FRB Spain).

作者信息

Zarranz-Ventura Javier, Marías-Pérez Sonia, Martin-Pinardel Ruben, Fernandez-Bonet Manel, Pina-Marin Begoña, Cobos Estefanía, Rodríguez-Fernandez Carmen Antía, Parrado-Carrillo Alba, Alarcón-Valero Isaac, Barnes Carles, Cilveti Esther, Aramburu-Claveria Julia, Ascaso-Puyuelo Francisco J, Calvo Pilar, Ruiz-Del-Tiempo Maria Pilar, Susanna-González Gabriela, Figueras-Roca Marc, Casaroli-Marano Ricardo P, Bernal-Morales Carolina

机构信息

Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.

Institut de Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.

出版信息

Eye (Lond). 2025 Jun 5. doi: 10.1038/s41433-025-03871-6.

Abstract

AIM

To evaluate clinical outcomes, treatment intervals, and safety outcomes of brolucizumab (BRO) treatment in a national neovascular age-related macular degeneration (nAMD) database.

METHODS

Multicentre, national, routine clinical care database study of nAMD eyes receiving ≥1 BRO injection. Demographics, visual acuity (VA) measured in logMAR letters, macular neovascularization (MNV) activity, number of injections, visit data and information on any adverse events were collected at baseline and at 3, 6, 9 and 12 months after BRO initiation for each patient/eye.

RESULTS

A total of 305 eyes received 1 BRO injection and 214 eyes (14% naïve, 86% switchers) completed 3 months follow-up. In switchers, the percentage of eyes extended to ≥8 week intervals at 3/6/9 months was 43.2%/45.7%/54.5% and to ≥10 week intervals was 12.9%/18.5%/13.6%, respectively. Eyes with VA ≥ 70 increased from 36% at baseline to 48% at 3 months and 50% at 9 months. MNV lesion activity status decreased from 94% (active/active-only SRF, 46/48%) at baseline to 56% (21/35%), 61% (23/38%), 76% (27/49%) and 65% (24/41%) at months 3/6/9 and 12, respectively. Adverse effects were observed in 6.5% of the treated eyes, being the most prevalent anterior uveitis (3.2%), vitritis (4.5%) and vasculitis (2.2%).

CONCLUSION

In this series BRO achieves an extension in the treatment intervals in half of the patients which require frequent reinjections (<8 weekly), reducing MNV activity in a third of this specific difficult-to-treat subgroup. The adverse event rates described are consistent with other cohorts and need to be considered to inform treatment decisions in case-by-case discussions.

摘要

目的

在一个全国性新生血管性年龄相关性黄斑变性(nAMD)数据库中评估布罗卢izumab(BRO)治疗的临床结局、治疗间隔和安全性结局。

方法

对接受≥1次BRO注射的nAMD眼进行多中心、全国性、常规临床护理数据库研究。在基线以及每位患者/眼开始使用BRO后的3、6、9和12个月收集人口统计学数据、以logMAR字母测量的视力(VA)、黄斑新生血管(MNV)活性、注射次数、就诊数据以及任何不良事件的信息。

结果

共有305只眼接受了1次BRO注射,214只眼(14%为初治患者,86%为转换治疗者)完成了3个月的随访。在转换治疗者中,在3/6/9个月时延长至≥8周间隔的眼的百分比分别为43.2%/45.7%/54.5%,延长至≥10周间隔的眼的百分比分别为12.9%/18.5%/13.6%。VA≥70的眼从基线时 的36%增加到3个月时的48%和9个月时的50%。MNV病变活性状态从基线时的94%(活跃/仅活跃性视网膜下液,46/48%)分别降至3/6/9和12个月时的56%(21/35%)、61%(23/38%)、76%(27/49%)和65%(24/41%)。在6.5%的治疗眼中观察到不良反应,最常见的是前葡萄膜炎(3.2%)、玻璃体炎(4.5%)和血管炎(2.2%)。

结论

在本系列研究中,BRO使一半需要频繁再次注射(<每周8次)的患者的治疗间隔得以延长,在这一特定的难治性亚组患者中有三分之一的患者MNV活性降低。所描述的不良事件发生率与其他队列一致,在个案讨论中为治疗决策提供参考时需要考虑这些情况。

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