Real-life neovascular AMD treatment considering reimbursement in Turkiye: One-year comparison of switching to intravitreal ranibizumab or aflibercept after treatment failure with three loading intravitreal bevacizumab injections.

Northern clinics of Istanbul Pub Date : 2024-10-03 eCollection Date: 2024-01-01 DOI:10.14744/nci.2024.75688
Mehmet Orkun Sevik, Nimet Zeynep Tiras, Aslan Aykut, Didem Dizdar Yigit, Ozlem Sahin
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Abstract

Objective: To compare one-year anatomical and functional results of switching to an on-label intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent (intravitreal ranibizumab [IVR] or aflibercept [IVA]) after treatment failure with three loading doses of off-label intravitreal bevacizumab (IVB), which is mandatory in the treatment of neovascular age-related macular degeneration (nAMD) to get reimbursement from Social Security Institution in Turkiye.

Methods: This comparative, real-life, retrospective cohort study included treatment-naïve nAMD patients treated starting with three loading doses of IVB, switched to three loading doses of IVR and IVA due to treatment failure after IVB loading, and followed up one year with a treat-and-extend (T&E) protocol with 2-week extension/shortening intervals. The primary outcomes were changes in best-corrected visual acuity (BCVA; logMAR) and central macular thickness (CMT, µm) one year after the switch, and the secondary outcomes were maximum treatment intervals, number of injections, and disease activity rates.

Results: The mean age (72.9±8.2 and 72.2±6.7, p=0.677) and gender (60.0% and 47.4% females, p=0.398) were similar among the IVR (35 eyes/patients) and IVA (38 eyes/patients) groups. The median BCVA and CMT were significantly improved during the study period (p<0.001) with no significant intergroup differences. The ratio of 4-, 6-, 8-, 10-, and 12-week maximum treatment intervals were 28.6%, 17.1%, 14.3%, 8.6%, and 31.4% in the IVR, and 13.2%, 15.8%, 21.1%, 15.8%, and 34.2% in the IVA group (p=0.492). The median (IQR) number of injections in the IVA group (8 [7-9]) was significantly lower than the IVR group (9 [8-12]) during the one-year T&E period (p=0.026). The disease activity rates were 34.3% and 26.4% one month (p=0.610) and 37.1% and 21.1% one year (p=0.195) after the switch in IVR and IVA groups.

Conclusion: This real-life comparison study indicates that, after the treatment failure with three loading doses of IVB, switching to either on-label anti-VEGF agent can be regarded as comparable considering functional and anatomical results. However, although maximum treatment intervals were not significantly different, fewer injections were required with aflibercept during the one-year T&E follow-up period.

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考虑到土耳其的报销问题,真实的新生血管性黄斑变性治疗:治疗失败后改用玻璃体内注射雷尼珠单抗或阿弗利贝赛普治疗一年的比较。
目的比较标签内抗血管内皮生长因子(anti-VEGF)药物(静脉注射雷尼珠单抗[IVR]或阿弗利百普[IVA])与标签外静脉注射贝伐单抗(IVB)治疗失败后转用标签内药物一年的解剖学和功能结果:这项比较性、真实生活、回顾性队列研究纳入了治疗无效的 nAMD 患者,他们开始时接受了三次负荷剂量的 IVB 治疗,由于 IVB 负荷剂量后治疗失败而改用三次负荷剂量的 IVR 和 IVA,并通过治疗和延长(T&E)方案进行为期一年的随访,延长/缩短间隔为两周。主要结果是切换一年后最佳矫正视力(BCVA;logMAR)和黄斑中心厚度(CMT,µm)的变化,次要结果是最长治疗间隔、注射次数和疾病活动率:IVR组(35眼/人)和IVA组(38眼/人)的平均年龄(72.9±8.2和72.2±6.7,P=0.677)和性别(60.0%和47.4%为女性,P=0.398)相似。在研究期间,BCVA 和 CMT 的中位数均有明显改善(p 结论:这项真实对比研究表明,在使用三种负荷剂量的 IVB 治疗失败后,考虑到功能和解剖结果,改用标签上的任何一种抗 VEGF 药物都具有可比性。不过,虽然最长治疗间隔没有明显差异,但在一年的T&E随访期间,使用aflibercept所需的注射次数更少。
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