Enríquez Ana Bety, Baumal Caroline R, Crane Ashley M, Witkin Andre J, Lally David R, Liang Michelle C, Enríquez José Ramón, Eichenbaum David A
New England Eye Center, Department of Ophthalmology, Tufts University School of Medicine, Boston, Massachusetts.
Retina-Vitreous Associates of Florida, Tampa.
JAMA Ophthalmol. 2021 Apr 1;139(4):441-448. doi: 10.1001/jamaophthalmol.2020.7085.
Outcome data are limited regarding early experience with brolucizumab, the most recently approved anti-vascular endothelial growth factor (VEGF) agent for the treatment of neovascular age-related macular degeneration (nAMD).
To report clinical outcomes after intravitreous injection (IVI) of brolucizumab, 6 mg, for nAMD.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective case series conducted at 15 private or academic ophthalmological centers in the United States included all consecutive patients with eyes treated with brolucizumab by 6 retina specialists between October 17, 2019, and April 1, 2020.
Treatment with brolucizumab IVI, 6 mg.
Change in mean visual acuity (VA) and optical coherence tomography parameters, including mean central subfield thickness and presence or absence of subretinal and/or intraretinal fluid. Secondary outcomes included ocular and systemic safety.
A total of 172 eyes from 152 patients (87 women [57.2%]; mean [SD] age, 80.0 [8.0] years) were included. Most eyes (166 [96.5%]) were not treatment naive, and 65.7% of these eyes (109 of 166) were switched from the prior anti-VEGF agent because of persistent fluid detected on optical coherence tomography scans. Study eyes received a mean (SD) of 1.46 (0.62) brolucizumab IVIs. The mean (SD) VA prior to starting brolucizumab was a 64.1 (15.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (Snellen equivalent, 20/50) and was a 63.3 (17.2) ETDRS letter score (Snellen equivalent, 20/63) at the last study evaluation (mean difference, 0.8; 95% CI, -2.7 to 4.3; P = .65). When analyzed by number of brolucizumab IVIs, the presence or absence of fluid prior to starting brolucizumab, or the presence or absence of intraocular inflammation after receiving brolucizumab, there was no difference in mean VA prior to starting brolucizumab compared with after brolucizumab IVIs or at the final study evaluation. The mean (SD) central subfield thickness in all eyes prior to starting brolucizumab was 296.7 (88.0) μm and was 269.8 (66.5) μm at the last study examination (mean difference, 26.9 µm; 95% CI, 9.0-44.7 µm; P = .003). Intraocular inflammation was reported in 14 eyes (8.1%) and was self-limited and resolved without treatment in almost half those eyes (n = 6). One previously reported eye (0.6%) had occlusive retinal vasculitis and severe loss of vision.
In this analysis of brolucizumab IVI for nAMD, VA remained stable, with a reduction in central subfield thickness. Intraocular inflammation events ranged from mild with spontaneous resolution to severe occlusive retinal vasculitis in 1 eye.
关于布罗珠单抗（brolucizumab）的早期使用经验，其作为最新获批用于治疗新生血管性年龄相关性黄斑变性（nAMD）的抗血管内皮生长因子（VEGF）药物，目前结果数据有限。
报告玻璃体内注射（IVI）6mg布罗珠单抗治疗nAMD后的临床结果。
设计、设置和参与者：这项回顾性病例系列研究在美国15个私立或学术眼科中心进行，纳入了2019年10月17日至2020年4月1日期间6位视网膜专家连续治疗的所有使用布罗珠单抗的患者。
玻璃体内注射6mg布罗珠单抗治疗。
平均视力（VA）以及光学相干断层扫描参数的变化，包括平均中心子野厚度以及视网膜下和/或视网膜内液的有无。次要结局包括眼部和全身安全性。
共纳入152例患者的172只眼（87例女性[57.2%]；平均[标准差]年龄，80.0[8.0]岁）。大多数眼睛（166只[96.5%]）并非初治，其中65.7%的眼睛（166只中的109只）因光学相干断层扫描发现持续存在的积液而从先前的抗VEGF药物转换治疗。研究眼平均（标准差）接受了1.46（0.62）次布罗珠单抗玻璃体内注射。开始使用布罗珠单抗前的平均（标准差）视力为64.1（15.9）早期糖尿病性视网膜病变研究（ETDRS）字母评分（Snellen等效值，20/50），在最后一次研究评估时为63.3（17.2）ETDRS字母评分（Snellen等效值，20/63）（平均差异，0.8；95%置信区间，-2.7至4.3；P = 0.65）。按布罗珠单抗玻璃体内注射次数、开始使用布罗珠单抗前积液有无或接受布罗珠单抗后眼内炎症有无进行分析时，开始使用布罗珠单抗前的平均视力与布罗珠单抗玻璃体内注射后或最后一次研究评估时相比无差异。所有眼睛开始使用布罗珠单抗前平均（标准差）中心子野厚度为296.7（88.0）μm，在最后一次研究检查时为269.8（66.5）μm（平均差异，26.9μm；95%置信区间，9.0 - 44.7μm；P = 0.003）。14只眼（8.1%）报告有眼内炎症，几乎一半的眼睛（n = 6）炎症为自限性且未经治疗自行消退。1只先前报告的眼睛（0.6%）发生了闭塞性视网膜血管炎并严重视力丧失。
在这项布罗珠单抗玻璃体内注射治疗nAMD的分析中，视力保持稳定，中心子野厚度降低。眼内炎症事件范围从轻度自行消退到1只眼中严重的闭塞性视网膜血管炎。
