RETINA ( IF 3.3 ) Pub Date : 2022-03-01 , DOI: 10.1097/iae.0000000000003344 Reinhard Angermann 1, 2 , Anna Lena Huber 1 , Yvonne Nowosielski 1 , Stefan Salcher 3 , Thomas Gasser 1 , Christof Seifarth 1 , Martina T Kralinger 1 , Claus Zehetner 1
Purpose:
To analyze and compare the effects of intravitreal brolucizumab versus aflibercept on systemic vascular endothelial growth factor (VEGF)-A levels in patients with neovascular age-related macular degeneration.
Methods:
In this prospective interventional case series study, brolucizumab (6.0 mg/50 µL) or aflibercept (2.0 mg/50 µL) was injected intravitreally in 30 patients each. Blood samples were drawn at baseline and 7 days and 28 days after the first injection. Systemic VEGF-A levels were measured using enzyme-linked immunosorbent assay. Thirty healthy individuals served as controls.
Results:
The median baseline systemic VEGF-A levels in the brolucizumab, aflibercept, and control groups were 10.8 (8.0–13.2), 12.0 (8.0–18.5), and 10.0 (8.0–15.1) pg/mL, respectively (P = 0.315). In the brolucizumab group, VEGF-A levels significantly decreased to 8.0 (8.0–11.5) pg/mL on Day 7 (P = 0.0254) and to 8.0 (8.0–8.0) pg/mL on Day 28 (P < 0.001). In the aflibercept group, VEGF-A levels significantly decreased to 8.0 (8.0–8.0) pg/mL on Day 7 (P < 0.001) but returned to the baseline level, 12.5 (8.5–14.6) pg/mL, on Day 28 (P = 0.120). Vascular endothelial growth factor–A levels were significantly different between the treatment groups after 28 days (P < 0.001).
Conclusion:
Intravitreal brolucizumab resulted in a sustained reduction of systemic VEGF-A levels until 28 days posttreatment, which raises concerns regarding its safety and long-term effects.
中文翻译:
玻璃体内注射阿柏西普或布罗昔珠单抗治疗新生血管年龄相关性黄斑变性后血管内皮生长因子系统水平的变化
目的:
分析和比较玻璃体内注射 brolucizumab 与阿柏西普对新生血管性年龄相关性黄斑变性患者全身血管内皮生长因子 (VEGF)-A 水平的影响。
方法:
在这项前瞻性介入病例系列研究中,分别对 30 名患者进行玻璃体内注射brolucizumab (6.0 mg/50 µL ) 或阿柏西普 (2.0 mg/50 µL )。在基线以及第一次注射后 7 天和 28 天抽取血样。使用酶联免疫吸附测定法测量全身 VEGF-A 水平。三十名健康人作为对照。
结果:
brolucizumab、阿柏西普和对照组的中位基线全身 VEGF-A 水平分别为 10.8 (8.0–13.2)、12.0 (8.0–18.5) 和 10.0 (8.0–15.1) pg/mL ( P = 0.315 )。在 brolucizumab 组中,VEGF-A 水平在第 7 天显着下降至 8.0 (8.0–11.5) pg/mL ( P = 0.0254),在第 28 天显着下降至 8.0 (8.0–8.0) pg/mL ( P < 0.001)。在阿柏西普组中,VEGF-A 水平在第 7 天显着下降至 8.0 (8.0–8.0) pg/mL ( P < 0.001),但在第 28 天恢复到基线水平 12.5 (8.5–14.6) pg/mL ( P = 0.120)。28 天后,治疗组之间的血管内皮生长因子 A 水平存在显着差异(P < 0.001)。
结论:
玻璃体内注射 brolucizumab 导致全身 VEGF-A 水平持续降低,直至治疗后 28 天,这引发了对其安全性和长期影响的担忧。