在 HAWK 和 HARRIER 中，brolucizumab 和 aflibercept 对色素上皮脱落和 RPE 下积液最大厚度的影响。

IF 4.4 Q1 OPHTHALMOLOGY Ophthalmology. Retina Pub Date : 2025-01-01 DOI:10.1016/j.oret.2024.07.012

Arshad M. Khanani MD, MA , Srinivas R. Sadda MD , David Sarraf MD , Ramin Tadayoni MD, PhD , David T. Wong MD , Anne-Sophie Kempf PhD , Insaf Saffar MSc, PharmD , Kinfemichael Gedif PhD , Andrew Chang MD, PhD

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引用次数: 0

摘要

目的比较HAWK研究和HARRIER研究中的brolucizumab和aflibercept治疗在减少新生血管性年龄相关性黄斑变性（nAMD）患者色素上皮脱落（PED）和视网膜下色素上皮（RPE）积液最大厚度方面的疗效：HAWK和HARRIER是为期96周的前瞻性、随机、双掩蔽、对照、多中心研究。受试者、参与者和/或对照：11个国家的1775名患者参与了HAWK研究，29个国家的1048名患者参与了HARRIER研究：在每月注射三次负荷剂量后，接受brolucizumab治疗的眼睛每12周注射一次（q12w），如果检测到疾病活动（DA），则每8周注射一次。Aflibercept治疗的眼睛固定每8周注射一次：主要结果测量：从基线到第96周，对brolucizumab和aflibercept治疗患者以及第16周出现DA的患者亚组（注射次数和治疗间隔相匹配）的黄斑PED和RPE下液体的最大厚度进行评估：第96周时，在PED和RPE下液的最大厚度方面，brolucizumab治疗患者与aflibercept治疗患者的平均百分比比基线降低幅度更大（PED：HAWK为19.7% [n=336] vs 11.9% [n=335]；HARRIER为29.5% [n=364] vs 18.3% [n=361]。RPE下液体：HAWK为75.4% vs 57.3%；HARRIER为86.0% vs 76.3%）。在第16周，观察到DA患者的平均百分比下降趋势相似：该分析表明，在 HAWK 和 HARRIER 中，与 aflibercept 相比，brolucizumab 可实现更大程度的 PED 和 RPE 下积液厚度减少。

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Effect of Brolucizumab and Aflibercept on the Maximum Thickness of Pigment Epithelial Detachments and Sub-Retinal Pigment Epithelium Fluid in HAWK and HARRIER

Objective

To compare the efficacy of brolucizumab and aflibercept treatment in reducing the maximum thickness of pigment epithelial detachments (PEDs) and sub-retinal pigment epithelium (sub-RPE) fluid in patients with neovascular age-related macular degeneration in the HAWK and HARRIER studies.

Design

HAWK and HARRIER were 96-week, prospective, randomized, double-masked, controlled, multicenter studies.

Participants

A total of 1775 patients across 11 countries were included in the HAWK study, and 1048 patients across 29 countries were included in the HARRIER study.

Intervention

After 3 monthly loading doses, brolucizumab-treated eyes received injections every 12 weeks or every 8 weeks if disease activity (DA) was detected. Aflibercept-treated eyes received fixed 8-week dosing.

Main Outcome Measures

Maximum thickness of PEDs and sub-RPE fluid across the macula were assessed at baseline through week 96 in the brolucizumab- and aflibercept-treated patients and in the patient subgroups with DA at week 16 (matched in terms of injection number and treatment interval).

Results

At week 96, there were greater mean percentage reductions from baseline in maximum thickness of both PEDs and sub-RPE fluid in brolucizumab-treated patients vs. aflibercept-treated patients (PED: 19.7% [n = 336] vs. 11.9% [n = 335] in HAWK; 29.5% [n = 364] vs. 18.3% [n = 361] in HARRIER. Sub-RPE fluid: 75.4% vs. 57.3% in HAWK; 86.0% vs. 76.3% in HARRIER). A similar trend in mean percentage reductions was observed in patients with DA at week 16.