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阿柏西普8mg持续疾病控制:视网膜新生血管疾病管理的新基准

Sustained disease control with aflibercept 8 mg: a new benchmark in the management of retinal neovascular diseases

Nature 等信源发布 2024-08-31 04:54

可切换为仅中文


Retinal neovascular diseases, such as neovascular age-related macular degeneration (nAMD), diabetic retinopathy (DR), diabetic macular oedema (DMO), and retinal vein occlusion (RVO), are major causes of visual impairment worldwide [1,2,3]. Vascular endothelial growth factor (VEGF) is considered critical in the pathophysiology of these conditions and randomized trials have established the efficacy and safety of agents with an anti-VEGF mechanism of action [4].

视网膜新生血管疾病,如新生血管性年龄相关性黄斑变性(nAMD),糖尿病性视网膜病变(DR),糖尿病性黄斑水肿(DMO)和视网膜静脉阻塞(RVO),是全球视力障碍的主要原因[1,2,3]。血管内皮生长因子(VEGF)在这些疾病的病理生理学中被认为是至关重要的,随机试验已经确定了具有抗VEGF作用机制的药物的有效性和安全性。

Extensive real-world studies of ranibizumab or aflibercept 2 mg have also demonstrated that effectiveness in clinical practice is possible [5,6,7,8], including maintenance of vision gains through 4 years with a proactive treat-and-extend (T&E) regimen in patients with nAMD [5], and vision gains over 3 years with a meaningful reduction in treatment burden after early, consistent dosing in patients with DMO [6].Patients, physicians, and caregivers generally prefer regimens with fewer clinic visits, and although T&E regimens allow gradual treatment interval extensions once disease inactivity is verified, treatment burden to achieve optimal outcomes can remain high [9, 10].

对雷珠单抗或阿柏西普2mg的广泛现实研究也表明,临床实践中的有效性是可能的[5,6,7,8],包括在nAMD患者中通过积极治疗和延长(T&E)方案维持4年的视力增加[5],以及在DMO患者早期,一致给药后3年内视力增加,治疗负担显着减轻[6]。患者,医生和护理人员通常更喜欢临床就诊次数较少的方案,尽管T&E方案允许在疾病不活动被证实后逐渐延长治疗间隔,但达到最佳结果的治疗负担可能仍然很高[9,10]。

Consequently, many patients in real-life settings receive fewer anti-VEGF injections than administered in clinical trials, despite dosing recommendations in the regulatory-approved product label, with potentially fewer monitoring visits often resulting in suboptimal outcomes [11], leading to non-adherence and non-persistence to long-term therapy [12].To address these real-world challenges, we introduce a new concept of “sustained disease control”, which is characterized by three inter-related goals of maintaining vision gains, rapid and resilient fluid control without clinically meaningful fluctuation, and with extended treatment intervals.

因此,尽管监管部门批准的产品标签中有剂量建议,但许多在现实生活中接受抗VEGF注射的患者接受的抗VEGF注射比在临床试验中更少,监测访视可能更少,往往导致不理想的结果(11),导致不依从性和长期治疗的不持久性(12)。为了应对这些现实世界的挑战,我们引入了“持续疾病控制”的新概念,其特点是三个相互关联的目标,即保持视力提高,快速和有弹性的液体控制,没有临床意义的波动,以及延长治疗间隔。

We sugge.

我们建议。

Data availability

数据可用性

All data generated or analysed during this study are included in this published article.

本研究期间生成或分析的所有数据均包含在本文中。

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Available at: https://investor.regeneron.com/static-files/d2cb2519-182f-42a6-8ac4-04544883febc. Accessed January 2024.Download referencesAcknowledgementsMedical writing and editorial support for the preparation of this manuscript (under the guidance of the authors) was provided by Afsaneh Khetrapal, BSc, of ApotheCom (UK), funded by Bayer Consumer Care AG, Basel, Switzerland, in accordance with Good Publication Pract.

网址:https://investor.regeneron.com/static-files/d2cb2519-182f-42a6-8ac4-04544883febc.2024年1月访问。下载参考文献致谢(在作者的指导下)编写本手稿的医学写作和编辑支持由ApotheCom(英国)BSc Afsaneh Khetrapal提供,由瑞士巴塞尔拜耳消费者保健公司资助,根据良好的出版实践。

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JFK receives consulting fees from AbbVie, Apellis, Bayer, Janssen, Nano Retina, Roche, Théa Pharmaceuticals, and Carl Zeiss Meditec AG; and is a member of data and safety monitoring boards or advisory boards for Alexion, Novo Nordisk, and Oxular. PL is a consultant for Aerie, Allergan, Apellis, Bausch + Lomb, Bayer, Biogen, Boehringer Ingelheim, I-Care, Genentech, Novartis, Ocular Therapeutix, Outlook Therapeutics, and Roche.

JFK从AbbVie,Apellis,Bayer,Janssen,Nano Retina,Roche,Théa Pharmaceuticals和Carl Zeiss Meditec AG获得咨询费;并且是Alexion,Novo Nordisk和Oxular的数据和安全监控委员会或咨询委员会的成员。PL是Aerie、Allergan、Apellis、Bausch+Lomb、Bayer、Biogen、Boehringer Ingelheim、I-Care、Genentech、Novartis、Oyal Therapeutix、Outlook Therapeutics和Roche的顾问。

CCW is a consultant for 4DMT, AbbVie, Adverum, Aerie, AGTC, Alcon, Annexon, Apellis, Arrowhead, Bausch + Lomb, Boehringer Ingelheim, Cholgene, Clearside, Curacle, EyePoint, Genentech, Gyroscope, IACTA, IVERIC Bio, Janssen, Kato, Kiora, Kodiak Sciences, Kriya, Merck, Nanoscope, NGM, Novartis, Ocular Therapeutix, OcuTerra, ONL, Opthea, Oxular, Palatin, PerceiveBio, Perfuse, Ray, RecensMedical, Regeneron Pharmaceuticals, RegenXBio, Roche, and Stealth; and has received research support from 4DMT, Adverum, AffaMed, Alexion, Alimera, Alkahest, Allgenesis, Amgen, Annexin, Annexon, Apellis, Asclepix, Bayer, Boehringer Ingelheim, Clearside, Curacle, EyePoint, Gemini, Genentech, GlaxoSmithKline, Gyroscope, IONIS, iRENIX, IVERIC bio, Kodiak Sciences, LMRI, Nanoscope, Neurotech, NGM, Novartis, Ocular Therapeutix, Ocuphire, OcuTerra, Opthea, Ophthotech, Oxurion, Oxular, Oyster Point, PerceiveBio, Regeneron Pharmaceuticals, RegenXBio, Roche, and UNITY.

CCW是4DMT、AbbVie、Adverum、Aerie、AGTC、Alcon、Annexon、Apellis、Arrowhead、Bausch+Lomb、Boehringer Ingelheim、Cholgene、Clearside、Curacle、EyePoint、Genentech、陀螺仪、IACTA、IVERIC Bio、Janssen、Kato、Kiora、Kodiak Sciences、Kriya、Merck、Nanoscope、NGM、Novartis、Octera、ONL、Opthea、Oxular、Palatin、PerceiveBio、Perfusse、Ray、RecensMedical、Regeneron Pharmaceuticals的顾问RegenXBio,Roche和Stealth;并获得了4DMT,Adverum,AffaMed,Alexion,Alimera,Alkahest,Allgenesis,Amgen,Annexin,Annexon,Apellis,Asclepix,Bayer,Boehringer Ingelheim,Clearside,Curacle,EyePoint,Gemini,Genentech,GlaxoSmithKline,Gyrome,IONIS,iRENIX,IVERIC bio,Kodiak Sciences,LMRI,Nanoscope,Neurotech,NGM,Novartis,Ocular Therapeutix,OcuTerra,Opthea,Ophthotech,Oxurion,Oxular,Oyster Point等的研究支持PerceiveBio,Regeneron Pharmaceuticals,RegenXBio,Roche和UNITY。

TYW receives consulting fees from Aldropika Therapeutics, Bayer, Boehringer Ingelheim, Genetech, Iveric Bio, Novartis, Oxurion, Plano, Roche, Sanofi, and Shanghai Henlius; and holds patents and is the cofounder of EyRiS and Visre. XZ, PMW, SL, LB, ZH and SF are employees of Bayer AG. KWC and KR are employees and stockholders of Regeneron Pharmaceuticals, Inc.

TYW从Aldropika Therapeutics,拜耳,勃林格殷格翰,Genetech,Iveric Bio,诺华,Oxurion,Plano,罗氏,赛诺菲和上海亨利士收取咨询费;。XZ、PMW、SL、LB、ZH和SF是拜耳公司的员工。KWC和KR是Regeneron Pharmaceuticals,Inc.的员工和股东。

SS is an advisor and contributes to the industry-sponso.

SS是一名顾问,为行业赞助商做出贡献。

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Reprints and permissionsAbout this articleCite this articleKorobelnik, JF., Lanzetta, P., Wykoff, C.C. et al. Sustained disease control with aflibercept 8 mg: a new benchmark in the management of retinal neovascular diseases.

转载和许可本文引用本文Korobelnik,JF。,Lanzetta,P.,Wykoff,C.C。等人。使用阿柏西普8 mg持续控制疾病:视网膜新生血管疾病管理的新基准。

Eye (2024). https://doi.org/10.1038/s41433-024-03312-wDownload citationReceived: 06 August 2024Revised: 16 August 2024Accepted: 22 August 2024Published: 31 August 2024DOI: https://doi.org/10.1038/s41433-024-03312-wShare this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

眼睛(2024)。https://doi.org/10.1038/s41433-024-03312-wDownload引文收到日期:2024年8月6日修订日期:2024年8月16日接受日期:2024年8月22日发布日期:2024年8月31日OI:https://doi.org/10.1038/s41433-024-03312-wShare本文与您共享以下链接的任何人都可以阅读此内容:获取可共享链接对不起,本文目前没有可共享的链接。复制到剪贴板。

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Quality of lifeRetinal diseases

生活质量视网膜疾病