Faricimab治疗次优反应性糖尿病黄斑水肿患者的12个月疗效:一项回顾性单中心研究

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2025-05-16 eCollection Date: 2025-01-01 DOI:10.2147/OPTH.S513009
Kamal El-Badawi, Benjamin Scrivens, Oluwaniyi Eke, Rehab Ismail, Lina Kobayter, Serena Salvatore
{"title":"Faricimab治疗次优反应性糖尿病黄斑水肿患者的12个月疗效:一项回顾性单中心研究","authors":"Kamal El-Badawi, Benjamin Scrivens, Oluwaniyi Eke, Rehab Ismail, Lina Kobayter, Serena Salvatore","doi":"10.2147/OPTH.S513009","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the visual and anatomical outcomes of switching diabetic macular oedema (DMO) patients with suboptimal response to aflibercept 2mg to faricimab over a 12-month period.</p><p><strong>Patients and methods: </strong>This retrospective single centre study enrolled 62 eyes from 50 patients with diabetic macular oedema (DMO) who demonstrated a sub-optimal response to aflibercept 2mg. Sub-optimal response was defined by a central subfield thickness (CST) exceeding 325µm or greater than 20% increase from the best CST despite receiving aflibercept 2mg at intervals of 8 weeks or less. Patients had received at least six 4-weekly doses of aflibercept 2mg. Faricimab was administered as four intravitreal loading injections at 4-weekly intervals, followed by a treat-and-extend approach. Outcome measures, including best-recorded visual acuity (BRVA), CST, and treatment intervals, were assessed at baseline, post-loading (6.5 ± 1.9 weeks) and at the latest clinic review (57.1 ± 19.7 weeks). Statistical analysis included paired t-tests (normal distribution) and Wilcoxon signed-rank tests (non-normal distribution), with p < 0.05 considered statistically significant.</p><p><strong>Results: </strong>Mean age was 63.9 (±11.4) years, 56% participants were male. At baseline, the mean BRVA was 67.6 (±11.8) letters, and CST measured 406.4 (±105.9) µm. The initial mean treatment interval was 6.5 (±1.8) weeks. BRVA increased to 70.4 (±12.7) letters (<i>p</i>=0.008), while CST reduced to 372.8 (±132.0) µm (<i>p</i>=0.002). The mean injection interval extended to 7.4 (±2.6) weeks (<i>p</i>=0.03). At the latest follow-up BRVA was maintained at 68.7 (±14.6) letters (<i>p</i>=0.572), and CST reduced further to 343.1 (±117.5) µm (<i>p</i>=0.020). At the final follow-up 53.2% were on ≥8-weekly intervals. The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered.</p><p><strong>Conclusion: </strong>DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":"19 ","pages":"1583-1591"},"PeriodicalIF":0.0000,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12091065/pdf/","citationCount":"0","resultStr":"{\"title\":\"Twelve-Month Outcomes of Faricimab for Patients with Sub-Optimally Responsive Diabetic Macular Oedema: A Retrospective Single-Centre Study.\",\"authors\":\"Kamal El-Badawi, Benjamin Scrivens, Oluwaniyi Eke, Rehab Ismail, Lina Kobayter, Serena Salvatore\",\"doi\":\"10.2147/OPTH.S513009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate the visual and anatomical outcomes of switching diabetic macular oedema (DMO) patients with suboptimal response to aflibercept 2mg to faricimab over a 12-month period.</p><p><strong>Patients and methods: </strong>This retrospective single centre study enrolled 62 eyes from 50 patients with diabetic macular oedema (DMO) who demonstrated a sub-optimal response to aflibercept 2mg. Sub-optimal response was defined by a central subfield thickness (CST) exceeding 325µm or greater than 20% increase from the best CST despite receiving aflibercept 2mg at intervals of 8 weeks or less. Patients had received at least six 4-weekly doses of aflibercept 2mg. Faricimab was administered as four intravitreal loading injections at 4-weekly intervals, followed by a treat-and-extend approach. Outcome measures, including best-recorded visual acuity (BRVA), CST, and treatment intervals, were assessed at baseline, post-loading (6.5 ± 1.9 weeks) and at the latest clinic review (57.1 ± 19.7 weeks). Statistical analysis included paired t-tests (normal distribution) and Wilcoxon signed-rank tests (non-normal distribution), with p < 0.05 considered statistically significant.</p><p><strong>Results: </strong>Mean age was 63.9 (±11.4) years, 56% participants were male. At baseline, the mean BRVA was 67.6 (±11.8) letters, and CST measured 406.4 (±105.9) µm. The initial mean treatment interval was 6.5 (±1.8) weeks. BRVA increased to 70.4 (±12.7) letters (<i>p</i>=0.008), while CST reduced to 372.8 (±132.0) µm (<i>p</i>=0.002). The mean injection interval extended to 7.4 (±2.6) weeks (<i>p</i>=0.03). At the latest follow-up BRVA was maintained at 68.7 (±14.6) letters (<i>p</i>=0.572), and CST reduced further to 343.1 (±117.5) µm (<i>p</i>=0.020). At the final follow-up 53.2% were on ≥8-weekly intervals. The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered.</p><p><strong>Conclusion: </strong>DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns.</p>\",\"PeriodicalId\":93945,\"journal\":{\"name\":\"Clinical ophthalmology (Auckland, N.Z.)\",\"volume\":\"19 \",\"pages\":\"1583-1591\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12091065/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical ophthalmology (Auckland, N.Z.)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/OPTH.S513009\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical ophthalmology (Auckland, N.Z.)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/OPTH.S513009","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

目的:评估在12个月的时间里,将对阿非利西贝2mg反应不佳的糖尿病性黄斑水肿(DMO)患者转换为法利昔单抗的视觉和解剖学结果。患者和方法:这项回顾性单中心研究纳入了来自50例糖尿病性黄斑水肿(DMO)患者的62只眼睛,这些患者对阿伯西普2mg的反应不佳。次优反应的定义是中心子场厚度(CST)超过325µm,或者在间隔8周或更短时间内服用阿伯西伯2mg后,中心子场厚度(CST)比最佳CST增加20%以上。患者接受了至少6次2mg阿非利西普,每4周一次。Faricimab以4周间隔进行4次玻璃体内负荷注射,随后采用治疗延长方法。结果测量,包括最佳记录视力(BRVA)、CST和治疗间隔,在基线、加载后(6.5±1.9周)和最新临床回顾(57.1±19.7周)进行评估。统计学分析采用配对t检验(正态分布)和Wilcoxon符号秩检验(非正态分布),以p < 0.05为差异有统计学意义。结果:平均年龄63.9(±11.4)岁,56%为男性。基线时,平均BRVA为67.6(±11.8)个字母,CST为406.4(±105.9)µm。初始平均治疗间隔为6.5(±1.8)周。BRVA增加到70.4(±12.7)个字母(p=0.008), CST降低到372.8(±132.0)µm (p=0.002)。平均注射间隔延长至7.4(±2.6)周(p=0.03)。最新随访时BRVA维持在68.7(±14.6)个字母(p=0.572), CST进一步降低至343.1(±117.5)µm (p=0.020)。在最终随访时,53.2%的患者≥8周。平均注射间隔增加到9.2(±3.2)周(p < 0.001),平均注射7.92(±2.53)次法利西单抗。结论:对阿非利西贝2mg反应不佳的DMO患者在使用法利西单抗维持视力的同时,解剖结果得到改善,治疗间隔延长,没有新的安全性问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Twelve-Month Outcomes of Faricimab for Patients with Sub-Optimally Responsive Diabetic Macular Oedema: A Retrospective Single-Centre Study.

Purpose: To evaluate the visual and anatomical outcomes of switching diabetic macular oedema (DMO) patients with suboptimal response to aflibercept 2mg to faricimab over a 12-month period.

Patients and methods: This retrospective single centre study enrolled 62 eyes from 50 patients with diabetic macular oedema (DMO) who demonstrated a sub-optimal response to aflibercept 2mg. Sub-optimal response was defined by a central subfield thickness (CST) exceeding 325µm or greater than 20% increase from the best CST despite receiving aflibercept 2mg at intervals of 8 weeks or less. Patients had received at least six 4-weekly doses of aflibercept 2mg. Faricimab was administered as four intravitreal loading injections at 4-weekly intervals, followed by a treat-and-extend approach. Outcome measures, including best-recorded visual acuity (BRVA), CST, and treatment intervals, were assessed at baseline, post-loading (6.5 ± 1.9 weeks) and at the latest clinic review (57.1 ± 19.7 weeks). Statistical analysis included paired t-tests (normal distribution) and Wilcoxon signed-rank tests (non-normal distribution), with p < 0.05 considered statistically significant.

Results: Mean age was 63.9 (±11.4) years, 56% participants were male. At baseline, the mean BRVA was 67.6 (±11.8) letters, and CST measured 406.4 (±105.9) µm. The initial mean treatment interval was 6.5 (±1.8) weeks. BRVA increased to 70.4 (±12.7) letters (p=0.008), while CST reduced to 372.8 (±132.0) µm (p=0.002). The mean injection interval extended to 7.4 (±2.6) weeks (p=0.03). At the latest follow-up BRVA was maintained at 68.7 (±14.6) letters (p=0.572), and CST reduced further to 343.1 (±117.5) µm (p=0.020). At the final follow-up 53.2% were on ≥8-weekly intervals. The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered.

Conclusion: DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
4.10
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信