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转换为布罗卢izumab治疗:真实世界中新生血管性年龄相关性黄斑变性患者在12个月和18个月时的注射间隔以及视力、解剖学和安全性结果

Switching to brolucizumab: injection intervals and visual, anatomical and safety outcomes at 12 and 18 months in real-world eyes with neovascular age-related macular degeneration.

作者信息

Coney Joseph M, Zubricky Ryan, Sinha Samriddhi Buxy, Sonbolian Nina, Zhou Lujia, Hull Thomas P, Lewis Shawn A, Miller David G, Novak Michael A, Pendergast Scott D, Pham Hang, Platt Sean M, Rao Llewelyn J, Schartman Jerome P, Singerman Lawrence J, Donkor Richard, Fink Margaret, McCoy Jasmyne, Karcher Helene

机构信息

Retina Associates of Cleveland Inc, 24075 Commerce Park, Beachwood, OH, 44122, USA.

Geisinger Eye Institute, Danville, PA, USA.

出版信息

Int J Retina Vitreous. 2023 Feb 1;9(1):8. doi: 10.1186/s40942-023-00445-0.

Abstract

BACKGROUND

The anti-vascular endothelial growth factor (anti-VEGF) injection interval influences treatment burden and compliance in neovascular age-related macular degeneration (nAMD). This real-world study investigates visual acuity (VA), injection-interval extension, central macular thickness (CMT) and safety in nAMD eyes switched to the anti-VEGF agent brolucizumab and followed for up to 18 months.

METHODS

This retrospective study included patients with nAMD who were switched from other anti-VEGF agents to brolucizumab only. Patient eyes were grouped into three nested cohorts with the overall cohort receiving ≥ 1 brolucizumab injection, the second receiving ≥ 3 brolucizumab injections with a follow-up period of ≥ 12 months and the third cohort receiving ≥ 3 brolucizumab injections with a follow-up period of ≥ 18 months. Study endpoints included changes from baseline at 12 or 18 months in VA, injection intervals, and CMT. Sub-group analyses were conducted using baseline injection interval length or baseline VA as qualifiers.

RESULTS

Overall, 482 eyes received ≥ 1 brolucizumab injection; 174 eyes received ≥ 3 brolucizumab injections with ≥ 12 months of follow-up, and 95 eyes received ≥ 3 brolucizumab injections with ≥ 18 months of follow-up. VA (mean [95% confidence intervals]) remained stable relative to baseline after 12 months (- 1.1 [- 3.7, 1.6] letters; p = 0.42) and 18 months (0.0 [- 3.1, 3.1] letters; p = 0.98) of brolucizumab treatment, respectively, and pre-switch injection intervals or baseline VA had no notable effect. Following the switch to brolucizumab, injection intervals were extended from baseline to month 12 by 26.9 (19.7, 34.0) days (p < 0.0001), and eyes with pre-switch injection intervals < 8 weeks were able to have their injection intervals extended by 23.6 days longer than eyes with pre-switch injection intervals ≥ 8 weeks. At 18 months, injection intervals were extended by 36.3 (25.6, 46.9) days (p < 0.0001) compared to baseline. Following switch to brolucizumab, CMT was reduced at both 12 and 18 months (12 months: - 35.2 (- 51.7, - 18.8) µm, p < 0.0001; 18 months: - 38.9 (- 54.3, - 22.0) µm, p < 0.0001). Intraocular inflammation-related adverse events were reported in 4.6% of brolucizumab-treated eyes.

CONCLUSIONS

This real-world study demonstrates that injection intervals may be significantly extended with maintained vision and reduced CMT in nAMD eyes switching to brolucizumab therapy from other anti-VEGFs.

摘要

背景

抗血管内皮生长因子(anti-VEGF)注射间隔会影响新生血管性年龄相关性黄斑变性(nAMD)的治疗负担和依从性。这项真实世界研究调查了改用抗VEGF药物布罗达单抗并随访长达18个月的nAMD患眼的视力(VA)、注射间隔延长情况、中心黄斑厚度(CMT)和安全性。

方法

这项回顾性研究纳入了仅从其他抗VEGF药物改用布罗达单抗的nAMD患者。患眼被分为三个嵌套队列,总体队列接受≥1次布罗达单抗注射,第二个队列接受≥3次布罗达单抗注射且随访期≥12个月,第三个队列接受≥3次布罗达单抗注射且随访期≥18个月。研究终点包括12个月或18个月时相对于基线的VA、注射间隔和CMT的变化。使用基线注射间隔长度或基线VA作为限定因素进行亚组分析。

结果

总体而言,482只眼接受了≥1次布罗达单抗注射;174只眼接受了≥3次布罗达单抗注射且随访≥12个月,95只眼接受了≥3次布罗达单抗注射且随访≥18个月。布罗达单抗治疗12个月(-1.1[-3.7,1.6]字母;p=0.42)和18个月(0.0[-3.1,3.1]字母;p=0.98)后,VA相对于基线保持稳定,且转换前注射间隔或基线VA无显著影响。改用布罗达单抗后,注射间隔从基线延长至第12个月时为26.9(19.7,34.0)天(p<0.0001),转换前注射间隔<8周的患眼比转换前注射间隔≥8周的患眼注射间隔能延长23.6天。在18个月时,与基线相比,注射间隔延长了36.3(25.6,46.9)天(p<0.0001)。改用布罗达单抗后,12个月和18个月时CMT均降低(12个月:-35.2[-51.7,-18.8]µm,p<0.0001;18个月:-38.9[-54.3,-22.0]µm,p<0.0001)。4.6%接受布罗达单抗治疗的患眼报告了与眼内炎症相关的不良事件。

结论

这项真实世界研究表明,从其他抗VEGF药物改用布罗达单抗治疗的nAMD患眼,注射间隔可能会显著延长,同时视力得以维持,CMT降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e171/9893658/8d45b3db4fb1/40942_2023_445_Fig1_HTML.jpg

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