Brolucizumab 治疗新生血管性老年黄斑变性的真实世界安全性结果：IRIS®注册研究结果。

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-05-01 Epub Date: 2024-03-23 DOI:10.1007/s40123-024-00920-3

Marco A Zarbin, Mathew W MacCumber, Helene Karcher, Eser Adiguzel, Andrew Mayhook, Andrew LaPrise, Ver L Bilano, Franklin Igwe, Michael S Ip, Charles C Wykoff

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The study assessed the predefined incident ocular adverse events of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO).Results: Overall, 614/18,312 eyes (3.4%) experienced any IOI, RV, and/or RO event. Median (interquartile range [IQR]) time to an event was 84 (42-167) days; 77.4% of events (475/614) occurred within 6 months after index date. Median (IQR) number of brolucizumab injections before an event was 2 (1-4). For eyes with an adverse event and visual acuity (VA) data (n = 406), median (IQR) change in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from pre-event VA was 0 (- 7 to + 5) at the 6-month follow-up; 50 eyes (12.3%) had a VA loss of 10 or more ETDRS letters. 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引用次数: 0

摘要

简介：目的：评估美国IRIS®（Intelligent Research in Sight）登记处提供的新血管性年龄相关性黄斑变性（nAMD）成人患者使用brolucizumab治疗的真实世界安全性结果：在这项回顾性研究中，18,312只眼睛（15,998名患者）在2019年10月8日（美国布卢单抗上市日）至2021年10月7日期间接受了≥1次玻璃体内注射布卢单抗治疗，并在首次注射（指标日）后随访≤2年。研究评估了眼内炎症（IOI）、视网膜血管炎（RV）和视网膜血管闭塞（RO）等预定义的眼部不良事件：共有 614/18,312 只眼睛（3.4%）发生了眼内炎、视网膜血管炎和/或视网膜血管闭塞事件。事件发生时间的中位数（四分位距[IQR]）为 84 (42-167) 天；77.4% 的事件（475/614）发生在指数日期后的 6 个月内。事件发生前注射博路单抗次数的中位数（IQR）为 2 次（1-4 次）。对于有不良事件和视力 (VA) 数据的眼睛（n = 406），在 6 个月的随访中，糖尿病视网膜病变早期治疗研究 (ETDRS) VA 与事件发生前相比的中位数（IQR）变化为 0（- 7 到 + 5）；50 只眼睛（12.3%）的 VA 下降了 10 个或更多 ETDRS 字母。男性患者（0.61 [0.53-0.71]）、年龄较大的患者（0.83 [0.76-0.90]）、未接受治疗的患者（0.51 [0.38-0.69]）以及在上市后第二年开始使用博路单抗的患者（0.68 [0.53-0.86] vs. 第一年）发生事件的风险（危险比 [95% 置信区间]）有所降低：结论：在这一大型真实世界博路单抗安全性研究中，3.4%的眼球发生了IOI、RV和/或RO事件。在发生不良事件且有VA数据的眼睛中，ETDRS视力变化的中位数为0个字母（IQR-7至+5）。

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 Safety Outcomes with Brolucizumab in Neovascular Age-Related Macular Degeneration: Findings from the IRIS® Registry.

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Real-World Safety Outcomes with Brolucizumab in Neovascular Age-Related Macular Degeneration: Findings from the IRIS® Registry.

Introduction: To assess real-world safety outcomes for adults with neovascular age-related macular degeneration (nAMD) treated with brolucizumab from the US-based IRIS® (Intelligent Research in Sight) Registry.

Methods: In this retrospective study, 18,312 eyes (15,998 patients) treated with ≥ 1 intravitreal brolucizumab injections between 8 October 2019 (US launch date for brolucizumab) and 7 October 2021 were followed up for ≤ 2 years after first injection (index date). The study assessed the predefined incident ocular adverse events of intraocular inflammation (IOI), retinal vasculitis (RV), and retinal vascular occlusion (RO).

Results: Overall, 614/18,312 eyes (3.4%) experienced any IOI, RV, and/or RO event. Median (interquartile range [IQR]) time to an event was 84 (42-167) days; 77.4% of events (475/614) occurred within 6 months after index date. Median (IQR) number of brolucizumab injections before an event was 2 (1-4). For eyes with an adverse event and visual acuity (VA) data (n = 406), median (IQR) change in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from pre-event VA was 0 (- 7 to + 5) at the 6-month follow-up; 50 eyes (12.3%) had a VA loss of 10 or more ETDRS letters. Risk of an event (hazard ratio [95% confidence interval]) was decreased in eyes from male patients (0.61 [0.53-0.71]), from older patients (0.83 [0.76-0.90]), from treatment-naive patients (0.51 [0.38-0.69]), and from patients who started brolucizumab in the second year after launch (0.68 [0.53-0.86] vs. first year).

Conclusion: In this large real-world brolucizumab safety study, 3.4% of eyes experienced an IOI, RV, and/or RO event. Among eyes that experienced an adverse event for which VA data were available, median ETDRS vision change was 0 letters (IQR - 7 to + 5).

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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