Long-term efficacy and safety of brolucizumab in neovascular age-related macular degeneration: A multicentre retrospective real-world study

IF 3 3区医学 Q1 OPHTHALMOLOGY Acta Ophthalmologica Pub Date : 2024-05-05 DOI:10.1111/aos.16699

Dong Ju Kim, Dong Geun Kim, Hyun Duck Kwak, Jae Yong Jang, Yong-Sok Ji, Seung Hyun Lee, Eun Kyoung Lee, Kyu Hyung Park, Jae Hui Kim, Jun Sung Lee, Yumi Song, Seong Taeck Kim, Min Ho Shin, Min Kim, Sang Jun Park, Kwangsic Joo, Min Sagong, Christopher Seungkyu Lee, Se Joon Woo

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Abstract

Purpose

To investigate the long-term efficacy and safety of intravitreal brolucizumab (BRZ) injections in patients with typical neovascular age-related macular degeneration (typical nAMD) and polypoidal choroidal vasculopathy (PCV).

Methods

This multicentre retrospective study included 401 eyes of 398 patients with nAMD who received BRZ injection(s), with a follow-up duration of ≥12 months. Changes in best-corrected visual acuity (BCVA), retinal fluid evaluation and central subfield thickness (CST) on optical coherence tomography were assessed. The efficacy of BRZ was compared between typical nAMD and PCV groups.

Results

Analyses were conducted with 280 eyes of 278 patients with typical nAMD and 121 eyes of 120 patients with PCV (mean age, 71.1 ± 8.6 years). 29 eyes (7.2%) were treatment naïve. The mean follow-up period was 15.3 ± 2.8 months; the mean number of BRZ injections within 1 year was 4.5 ± 1.7. BCVA was maintained during the follow-up period, and CST significantly improved from the first injection month and was maintained for 12 months in both the typical nAMD and PCV groups. The dry macula proportion increased from 2.7% at baseline to 56.1% at 1 month and 42.9% at 12 months. Among the 18 eyes that underwent indocyanine green angiography both before and after treatment, 10 (55.6%) showed polyp regression. Overall, the incidence of intraocular inflammation (IOI), retinal vasculitis and occlusive retinal vasculitis was 9.4% (38 eyes), 1.2% (5 eyes) and 0.5% (2 eyes), respectively. IOI occurred from the first to the sixth injections, with an average IOI onset of 28.5 ± 1.4 days. All eyes achieved IOI resolution, although the two eyes with occlusive retinal vasculitis showed a severe visual decline after IOI resolution.

Conclusion

Brolucizumab was effective in maintaining BCVA and managing fluid in eyes with nAMD for up to 1 year, exhibiting a high polyp regression rate. However, the not uncommon incidence of IOI and the severe visual decline caused by the rare occlusive retinal vasculitis following BRZ treatment underscore the importance of careful monitoring and timely management.

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博路单抗治疗新生血管性老年黄斑变性的长期疗效和安全性：一项多中心回顾性真实世界研究。

目的：研究玻璃体内注射布鲁珠单抗（BRZ）对典型新生血管性年龄相关性黄斑变性（典型nAMD）和多形性脉络膜血管病（PCV）患者的长期疗效和安全性：这项多中心回顾性研究包括398名接受BRZ注射的nAMD患者的401只眼睛，随访时间≥12个月。研究评估了最佳矫正视力（BCVA）、视网膜液评估和光学相干断层扫描中央子场厚度（CST）的变化。在典型的 nAMD 组和 PCV 组之间比较了 BRZ 的疗效：对 278 名典型 nAMD 患者的 280 只眼睛和 120 名 PCV 患者的 121 只眼睛（平均年龄为 71.1 ± 8.6 岁）进行了分析。29只眼睛（7.2%）为治疗前患者。平均随访时间为 15.3 ± 2.8 个月；一年内注射 BRZ 的平均次数为 4.5 ± 1.7 次。在随访期间，BCVA 保持不变，典型 nAMD 组和 PCV 组的 CST 从注射的第一个月开始明显改善，并保持了 12 个月。干黄斑比例从基线时的 2.7% 增加到 1 个月时的 56.1%，12 个月时的 42.9%。在治疗前后接受吲哚青绿血管造影的 18 只眼睛中，有 10 只（55.6%）的息肉消退。总体而言，眼内炎症（IOI）、视网膜血管炎和闭塞性视网膜血管炎的发生率分别为 9.4%（38 眼）、1.2%（5 眼）和 0.5%（2 眼）。IOI发生在第一次注射到第六次注射期间，平均IOI发生时间为（28.5 ± 1.4）天。虽然两只患有闭塞性视网膜血管炎的眼睛在IOI缓解后出现了严重的视力下降，但所有眼睛的IOI都得到了缓解：结论：在长达一年的时间里，布卢珠单抗能有效维持 nAMD 患者的 BCVA 并控制积液，息肉消退率也很高。然而，IOI的发生率并不罕见，而且在BRZ治疗后，罕见的闭塞性视网膜血管炎会导致视力严重下降，这凸显了仔细监测和及时处理的重要性。

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来源期刊

Acta Ophthalmologica 医学-眼科学

CiteScore

7.60

自引率

5.90%

发文量

433

审稿时长

6 months

期刊介绍： Acta Ophthalmologica is published on behalf of the Acta Ophthalmologica Scandinavica Foundation and is the official scientific publication of the following societies: The Danish Ophthalmological Society, The Finnish Ophthalmological Society, The Icelandic Ophthalmological Society, The Norwegian Ophthalmological Society and The Swedish Ophthalmological Society, and also the European Association for Vision and Eye Research (EVER). Acta Ophthalmologica publishes clinical and experimental original articles, reviews, editorials, educational photo essays (Diagnosis and Therapy in Ophthalmology), case reports and case series, letters to the editor and doctoral theses.