法利昔单抗在意大利治疗渗出性新生血管性年龄相关性黄斑变性和糖尿病性黄斑水肿：FARIT真实世界研究。

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2025-07-19 DOI:10.1007/s40123-025-01204-0

Marco Lupidi, Cristiana Iaculli, Luisa Marco, Settimio Rossi, Emilia Sicari, Giulia Villa, Vittorio Pirani

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引用次数: 0

摘要

Faricimab是一种双特异性抗体，与单独抑制血管内皮生长因子（VEGF）相比，在新生血管性年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）中具有更好的疾病控制和更长的持久性。本研究旨在评估其在意大利临床实践中的有效性、持久性以及经济和社会负担。方法：FARIT是一项在意大利四个地点进行的回顾性、观察性、多中心队列研究。纳入了从2023年2月开始使用faricimab且随访≥6个月的nAMD或DME成年患者。通过图表回顾和电子调查收集临床结果、治疗模式和患者报告的数据。结果：共87只眼（nAMD 68只，DME 19只），随访时间中位数为14个月。其中抗vegf 33眼（nAMD 24眼，DME 9眼）naïve。1年时，95.4%和100%患有nAMD和DME的naïve眼睛分别达到每12周（Q12W）或更长时间的给药间隔；63.6%和100%每16周接受一次治疗（Q16W）。切换眼中，92.4% （nAMD）和71.5% （DME）达到≥Q12W， Q16W剂量下分别为35.9%和42.9%。在完全加载阶段后，加载后随访期间（nAMD组12个月，DME组10个月）中位注射次数为nAMD组3次，DME组2次。延长井段的目的是为了稳定/改善视力和提高流体分辨率。患者和护理人员报告了高满意度和减轻负担，更少的注射和更好的视觉效果对改善生活质量贡献最大。经济分析显示，从医疗保健系统的角度来看，12个月的直接成本（不包括药品成本）为1223.8欧元/患者。结论：Faricimab在treatment-naïve和之前用nAMD和DME治疗过的眼睛中提供了有效的疾病控制和延长治疗间隔，显示出快速的解剖反应和减轻注射负担。

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Faricimab in the Treatment of Exudative Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Italy: The FARIT Real World Study.

Introduction: Faricimab is a bispecific antibody that enables greater disease control and extended durability compared with vascular endothelial growth factor (VEGF) inhibition alone in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). This study aimed to evaluate its effectiveness, durability, and economic and social burden in Italian clinical practice.

Methods: FARIT was a retrospective, observational, multicenter cohort study across four Italian sites. Adult patients with nAMD or DME who initiated faricimab from February 2023 and had ≥ 6 months of follow-up were included. Clinical outcomes, treatment patterns, and patient-reported data were collected through chart review and electronic surveys.

Results: A total of 87 eyes (68 with nAMD, 19 with DME) were followed for a median of 14 months. Among them, 33 eyes (24 with nAMD, 9 with DME) were anti-VEGF naïve. At 1 year, 95.4% and 100% of naïve eyes with nAMD and DME, respectively, reached a dosing interval of every 12 weeks (Q12W) or longer; 63.6% and 100% received the treatment every 16 weeks (Q16W). Among switch eyes, 92.4% (nAMD) and 71.5% (DME) reached ≥ Q12W, with 35.9% and 42.9%, respectively, on Q16W dosing. After a full loading phase, the median number of injections administered during the post-loading follow-up period (12 months for nAMD, 10 months for DME) was three for nAMD and two for DME. The interval extensions were driven by visual acuity stabilization/improvement and fluid resolution. Patients and caregivers reported high satisfaction and reduced burden, with fewer injections and better visual outcomes contributing most to improved quality of life. Economic analysis showed a 12-month direct cost (excluding the drug cost) of 1223.8 €/patient from the healthcare system perspective.

Conclusions: Faricimab provided effective disease control and extended treatment intervals in treatment-naïve and previously treated eyes with nAMD and DME, showing a fast anatomical response and reduced injection burden.

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies. Open Access All articles published by Ophthalmology and Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. Digital Features and Plain Language Summaries Ophthalmology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. 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At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor. 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