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三级中心使用雷珠单抗生物类似药与阿柏西普治疗新生血管性年龄相关性黄斑变性的经验:一项回顾性研究

A Tertiary Centre's Experience With Using Ranibizumab Biosimilar Compared to Aflibercept for Neovascular Age-Related Macular Degeneration: A Retrospective Study.

作者信息

Bilal Ahmed, Bilal Muslim, Usman Danyal, Elahi Aarij, Al-Bermani Ayad

机构信息

Ophthalmology, University Hospital of Wales, Cardiff, GBR.

School of Medicine, Cardiff University, Cardiff, GBR.

出版信息

Cureus. 2024 Dec 12;16(12):e75586. doi: 10.7759/cureus.75586. eCollection 2024 Dec.

Abstract

Objective This study aims to evaluate the real-world efficacy of ranibizumab biosimilar (Ongavia), compared to aflibercept (Eylea), in the treatment of treatment-naïve neovascular age-related macular degeneration (nAMD) at a busy tertiary eye care centre. Methods A retrospective analysis of medical records from August 2022 to August 2024 was conducted, comparing treatment outcomes in treatment-naive nAMD patients who received either Ongavia or Eylea intravitreal anti-VEGF (vascular endothelial growth factor) injections under a treat-and-extend protocol. Initial and 12-month outcome measures post-treatment initiation were collected, including best-corrected visual acuity (BCVA), central retinal thickness (CRT), prescribed treatment intervals, actual injection frequency, and the average total number of injections per eye over 12 months. Results A total of 62 eyes met the inclusion criteria. Over 12 months of follow-up, patients receiving Eylea (n = 36) showed a significantly greater improvement in BCVA (7.08 ± 4.12), p = 0.018, compared to Ongavia (n = 26) (-1.9 ± 3.31). CRT reductions were also more substantial for Eylea (-116.21 µm ± 35.61 µm) than for Ongavia (-51.14 µm ± 22.21 µm), p = 0.002. The average number of injections was 6.55 for Ongavia and 5.75 for Eylea over the 12-month follow-up. Excluding the initial three loading doses, observed injection intervals averaged 9.49 weeks for Eylea and 8.17 weeks for Ongavia. Notably, for the total study period, 164 out of 171 (96%) Ongavia injections were prescribed at four-week intervals, compared to 110 out of 207 (53%) for Eylea. However, capacity constraints impacted adherence to prescribed dosing schedules, affecting efficacy. Conclusion Our study indicates reduced visual and morphological outcomes with Ongavia compared to Eylea in treating nAMD when monthly injections cannot be provided as prescribed. Given clinical capacity constraints, Eylea's greater potency and durability prove advantageous, allowing extended intervals and reducing the reliance on strict monthly dosing. This highlights the need for additional resources to support frequent biosimilar administration and ensure effective ranibizumab treatment. A comprehensive cost-benefit analysis is warranted to assess whether increased clinic capacity offsets Ongavia's lower per-injection cost, compared to Eylea.

摘要

目的 本研究旨在评估在一家繁忙的三级眼科护理中心,雷珠单抗生物类似药(Ongavia)与阿柏西普(Eylea)相比,在治疗初治的新生血管性年龄相关性黄斑变性(nAMD)方面的真实世界疗效。方法 对2022年8月至2024年8月的病历进行回顾性分析,比较在治疗并延长方案下接受Ongavia或Eylea玻璃体内抗血管内皮生长因子(VEGF)注射的初治nAMD患者的治疗结果。收集治疗开始后的初始和12个月的结果指标,包括最佳矫正视力(BCVA)、中心视网膜厚度(CRT)、规定的治疗间隔、实际注射频率以及每只眼睛在12个月内的平均总注射次数。结果 共有62只眼睛符合纳入标准。在12个月的随访中,接受Eylea治疗的患者(n = 36)的BCVA改善程度(7.08 ± 4.12)显著高于接受Ongavia治疗的患者(n = 26)(-1.9 ± 3.31),p = 0.018。Eylea组的CRT降低幅度(-116.21 µm ± 35.61 µm)也大于Ongavia组(-51.14 µm ± 22.21 µm),p = 0.002。在12个月的随访中,Ongavia的平均注射次数为6.55次,Eylea为5.75次。排除最初的三次负荷剂量后,观察到的Eylea注射间隔平均为9.49周,Ongavia为8.17周。值得注意的是,在整个研究期间,171次Ongavia注射中有164次(96%)是按四周间隔开具的,而Eylea的207次注射中有110次(53%)是按此间隔开具的。然而,能力限制影响了对规定给药方案的依从性,进而影响疗效。结论 我们的研究表明,在无法按规定每月注射的情况下,与Eylea相比,Ongavia在治疗nAMD时视觉和形态学结果有所降低。考虑到临床能力限制,Eylea更强的效力和更长的耐久性证明是有利的,允许延长间隔并减少对严格每月给药的依赖。这突出了需要额外资源来支持频繁的生物类似药给药并确保有效的雷珠单抗治疗。有必要进行全面的成本效益分析,以评估增加的诊所能力是否能抵消Ongavia与Eylea相比每注射成本较低的优势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c10a/11724737/6ba1d36c8cb4/cureus-0016-00000075586-i01.jpg

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