Expert Panel Consensus for Optimizing Outcomes in Neovascular Age-Related Macular Degeneration in the Context of Suboptimal Response to a Biosimilar: The Role of Aflibercept.

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2024-11-02 eCollection Date: 2024-01-01 DOI:10.2147/OPTH.S481772
Nirodhini Narendran, Clare Bailey, Louise Downey, Richard Gale, Ajay Kotagiri, Ian Pearce, Christina A Rennie, Sobha Sivaprasad, James Talks, Peter Morgan-Warren, Jackie Napier, Carolyn O'Neil, Timothy Seeborne
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Abstract

Purpose: The inclusion of ranibizumab biosimilars into National Health Service England commissioning recommendations published in 2022 created a need for expert guidance to optimize treatment outcomes in patients with neovascular age-related macular degeneration (nAMD) who otherwise may not have received first-line ranibizumab. This article provides a consensus treatment pathway supporting timely identification and management of a suboptimal response to these therapies, thereby aiming to facilitate clinically meaningful outcomes and efficient management of service capacity under specific circumstances where ranibizumab biosimilars may be initiated as a first-line treatment.

Methods: Two structured round-table meetings of UK medical retina specialists were held in person and virtually on September 22 and November 3, 2022, respectively. These meetings were organized and funded by Bayer.

Results: The panel provided guidance on the implementation of an early treatment optimization pathway in cases where ranibizumab biosimilars are used as a first-line treatment, including recommendations on patient suitability and capacity requirements, and criteria for identification and strategies for management of a suboptimal response. The panel discussed the role of aflibercept treatment and its potential benefits and outlined recommendations on switching ranibizumab biosimilar suboptimal responders to an aflibercept treat-and-extend regimen, where appropriate.

Conclusion: Developed by a retinal expert panel, this early treatment optimization pathway provides guidance to facilitate optimal long-term patient outcomes while addressing capacity and resourcing constraints in circumstances of first-line ranibizumab biosimilar use for nAMD, including how aflibercept may be used in cases with a suboptimal response. Therefore, this fills an important gap in guidance on navigating the new treatment landscape.

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在生物仿制药疗效不佳的情况下优化新生血管性老年黄斑变性疗效的专家组共识:阿弗利百普的作用。
目的:2022年发布的英格兰国民健康服务局(National Health Service England)委托建议中纳入了雷尼珠单抗生物仿制药,这就需要专家提供指导,以优化新生血管性年龄相关性黄斑变性(nAMD)患者的治疗效果,否则这些患者可能无法接受一线雷尼珠单抗治疗。本文提供了一个共识治疗路径,支持及时发现和管理对这些疗法的次优反应,从而旨在促进在特定情况下将雷尼珠单抗生物仿制药作为一线治疗时,获得有临床意义的结果并有效管理服务能力:英国视网膜医学专家分别于 2022 年 9 月 22 日和 11 月 3 日亲自参加和通过虚拟方式召开了两次结构化圆桌会议。这些会议由拜耳组织和资助:专家小组为在使用雷尼珠单抗生物类似物作为一线治疗的情况下实施早期治疗优化路径提供了指导,包括关于患者适宜性和能力要求的建议,以及次优反应的识别标准和管理策略。专家组讨论了阿弗利百普治疗的作用及其潜在益处,并概述了在适当情况下将雷尼珠单抗生物仿制药次优反应者转为阿弗利百普治疗和延长方案的建议:由视网膜专家小组制定的这一早期治疗优化路径为优化患者的长期治疗效果提供了指导,同时解决了一线使用雷尼珠单抗生物类似物治疗nAMD时的能力和资源限制问题,包括如何将阿夫利百普用于反应不达标的病例。因此,这填补了新治疗方法指导方面的一项重要空白。
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