阿弗利贝西坦耐药 nAMD 患者改用 Brolucizumab 时负荷剂量方案的效果

IF 1.8 4区 医学 Q3 OPHTHALMOLOGY
Hiroyuki Kamao, Erika Mitsui, Yuto Date, Katsutoshi Goto, Kenichi Mizukawa, Atsushi Miki
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We assessed the best-corrected visual acuity (BCVA), central retinal thickness (CRT) at the fovea, subfoveal choroidal thickness (SFCT), IVBr status (number of injections and last injection interval), and retinal exudate status on optical coherence tomography. <i>Results</i>. Overall, 52 eyes received ≥1 IVBr; 26 eyes received ≥3 IVBr with 12-month follow-up. A total of 13 eyes in the loading group and 13 eyes in the nonloading group were reviewed. One year after switching, BCVA changed from 0.28 ± 0.25 to 0.19 ± 0.28 in the loading group (<span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.6359 19.289 8.8423\" width=\"19.289pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,11.658,0)\"></path></g></svg><span></span><span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"22.8711838 -8.6359 21.918 8.8423\" width=\"21.918pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,22.921,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,29.161,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,32.125,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,38.365,0)\"></path></g></svg>)</span></span> and from 0.25 ± 0.20 to 0.23 ± 0.25 in the nonloading group (<span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.6359 19.289 8.8423\" width=\"19.289pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"><use xlink:href=\"#g113-81\"></use></g><g transform=\"matrix(.013,0,0,-0.013,11.658,0)\"><use xlink:href=\"#g117-34\"></use></g></svg><span></span><span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"22.8711838 -8.6359 21.918 8.8423\" width=\"21.918pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,22.921,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,29.161,0)\"><use xlink:href=\"#g113-47\"></use></g><g transform=\"matrix(.013,0,0,-0.013,32.125,0)\"></path></g><g transform=\"matrix(.013,0,0,-0.013,38.366,0)\"><use xlink:href=\"#g113-51\"></use></g></svg>).</span></span> The mean CRT decreased from 263.6 ± 40.7 <i>µ</i>m to 221.7 ± 54.6 <i>µ</i>m in the loading group (<span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.6359 19.289 8.8423\" width=\"19.289pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"><use xlink:href=\"#g113-81\"></use></g><g transform=\"matrix(.013,0,0,-0.013,11.658,0)\"><use xlink:href=\"#g117-34\"></use></g></svg><span></span><span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"22.8711838 -8.6359 21.918 8.8423\" width=\"21.918pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,22.921,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,29.161,0)\"><use xlink:href=\"#g113-47\"></use></g><g transform=\"matrix(.013,0,0,-0.013,32.125,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,38.365,0)\"></path></g></svg>),</span></span> while it only changed from 244.9 ± 77.2 <i>µ</i>m to 221.0 ± 78.7 <i>µ</i>m in the nonloading group (<span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.6359 19.289 8.8423\" width=\"19.289pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"><use xlink:href=\"#g113-81\"></use></g><g transform=\"matrix(.013,0,0,-0.013,11.658,0)\"><use xlink:href=\"#g117-34\"></use></g></svg><span></span><span><svg height=\"8.8423pt\" style=\"vertical-align:-0.2064009pt\" version=\"1.1\" viewbox=\"22.8711838 -8.6359 21.918 8.8423\" width=\"21.918pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,22.921,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,29.161,0)\"><use xlink:href=\"#g113-47\"></use></g><g transform=\"matrix(.013,0,0,-0.013,32.125,0)\"><use xlink:href=\"#g113-51\"></use></g><g transform=\"matrix(.013,0,0,-0.013,38.365,0)\"></path></g></svg>).</span></span> Both the loading and nonloading groups achieved 69% dry macula. The number of injections received was significantly higher in the loading group (7.6 ± 0.6 vs. 6.8 ± 0.4, <span><svg height=\"9.2729pt\" style=\"vertical-align:-0.6370001pt\" version=\"1.1\" viewbox=\"-0.0498162 -8.6359 21.464 9.2729\" width=\"21.464pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,0,0)\"><use xlink:href=\"#g113-81\"></use></g><g transform=\"matrix(.013,0,0,-0.013,13.833,0)\"></path></g></svg><span></span><span><svg height=\"9.2729pt\" style=\"vertical-align:-0.6370001pt\" version=\"1.1\" viewbox=\"27.221183800000002 -8.6359 28.182 9.2729\" width=\"28.182pt\" xmlns=\"http://www.w3.org/2000/svg\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"><g transform=\"matrix(.013,0,0,-0.013,27.271,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,33.511,0)\"><use xlink:href=\"#g113-47\"></use></g><g transform=\"matrix(.013,0,0,-0.013,36.475,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,42.715,0)\"><use xlink:href=\"#g113-49\"></use></g><g transform=\"matrix(.013,0,0,-0.013,48.955,0)\"></path></g></svg>).</span></span> Two patients (4.2%) developed intraocular inflammation. <i>Conclusion</i>. Switching to brolucizumab from aflibercept for eyes with nAMD with resistance to bimonthly injections of aflibercept is a valuable treatment option with and without the loading regimen. This trial is registered with UMIN000023676.","PeriodicalId":16674,"journal":{"name":"Journal of Ophthalmology","volume":"3 1","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Effect of a Loading Dose Regimen in the Switch to Brolucizumab for Patients with Aflibercept-Resistant nAMD\",\"authors\":\"Hiroyuki Kamao, Erika Mitsui, Yuto Date, Katsutoshi Goto, Kenichi Mizukawa, Atsushi Miki\",\"doi\":\"10.1155/2024/3673930\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<i>Purpose</i>. To evaluate the one-year outcomes of switching to brolucizumab with and without a loading dose regimen (three monthly injections) in eyes with aflibercept-resistant neovascular age-related macular degeneration (nAMD). <i>Methods</i>. We retrospectively studied nAMD patients who had retinal exudate under bimonthly injections of aflibercept and were switched to brolucizumab from aflibercept. Patients were grouped into intravitreal brolucizumab injection (IVBr) with a loading dose regimen (loading group) and without a loading dose regimen (nonloading group). We assessed the best-corrected visual acuity (BCVA), central retinal thickness (CRT) at the fovea, subfoveal choroidal thickness (SFCT), IVBr status (number of injections and last injection interval), and retinal exudate status on optical coherence tomography. <i>Results</i>. Overall, 52 eyes received ≥1 IVBr; 26 eyes received ≥3 IVBr with 12-month follow-up. A total of 13 eyes in the loading group and 13 eyes in the nonloading group were reviewed. One year after switching, BCVA changed from 0.28 ± 0.25 to 0.19 ± 0.28 in the loading group (<span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.6359 19.289 8.8423\\\" width=\\\"19.289pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"></path></g><g transform=\\\"matrix(.013,0,0,-0.013,11.658,0)\\\"></path></g></svg><span></span><span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"22.8711838 -8.6359 21.918 8.8423\\\" width=\\\"21.918pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,22.921,0)\\\"></path></g><g transform=\\\"matrix(.013,0,0,-0.013,29.161,0)\\\"></path></g><g transform=\\\"matrix(.013,0,0,-0.013,32.125,0)\\\"></path></g><g transform=\\\"matrix(.013,0,0,-0.013,38.365,0)\\\"></path></g></svg>)</span></span> and from 0.25 ± 0.20 to 0.23 ± 0.25 in the nonloading group (<span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.6359 19.289 8.8423\\\" width=\\\"19.289pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"><use xlink:href=\\\"#g113-81\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,11.658,0)\\\"><use xlink:href=\\\"#g117-34\\\"></use></g></svg><span></span><span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"22.8711838 -8.6359 21.918 8.8423\\\" width=\\\"21.918pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,22.921,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,29.161,0)\\\"><use xlink:href=\\\"#g113-47\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,32.125,0)\\\"></path></g><g transform=\\\"matrix(.013,0,0,-0.013,38.366,0)\\\"><use xlink:href=\\\"#g113-51\\\"></use></g></svg>).</span></span> The mean CRT decreased from 263.6 ± 40.7 <i>µ</i>m to 221.7 ± 54.6 <i>µ</i>m in the loading group (<span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.6359 19.289 8.8423\\\" width=\\\"19.289pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"><use xlink:href=\\\"#g113-81\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,11.658,0)\\\"><use xlink:href=\\\"#g117-34\\\"></use></g></svg><span></span><span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"22.8711838 -8.6359 21.918 8.8423\\\" width=\\\"21.918pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,22.921,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,29.161,0)\\\"><use xlink:href=\\\"#g113-47\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,32.125,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,38.365,0)\\\"></path></g></svg>),</span></span> while it only changed from 244.9 ± 77.2 <i>µ</i>m to 221.0 ± 78.7 <i>µ</i>m in the nonloading group (<span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.6359 19.289 8.8423\\\" width=\\\"19.289pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"><use xlink:href=\\\"#g113-81\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,11.658,0)\\\"><use xlink:href=\\\"#g117-34\\\"></use></g></svg><span></span><span><svg height=\\\"8.8423pt\\\" style=\\\"vertical-align:-0.2064009pt\\\" version=\\\"1.1\\\" viewbox=\\\"22.8711838 -8.6359 21.918 8.8423\\\" width=\\\"21.918pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,22.921,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,29.161,0)\\\"><use xlink:href=\\\"#g113-47\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,32.125,0)\\\"><use xlink:href=\\\"#g113-51\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,38.365,0)\\\"></path></g></svg>).</span></span> Both the loading and nonloading groups achieved 69% dry macula. The number of injections received was significantly higher in the loading group (7.6 ± 0.6 vs. 6.8 ± 0.4, <span><svg height=\\\"9.2729pt\\\" style=\\\"vertical-align:-0.6370001pt\\\" version=\\\"1.1\\\" viewbox=\\\"-0.0498162 -8.6359 21.464 9.2729\\\" width=\\\"21.464pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,0,0)\\\"><use xlink:href=\\\"#g113-81\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,13.833,0)\\\"></path></g></svg><span></span><span><svg height=\\\"9.2729pt\\\" style=\\\"vertical-align:-0.6370001pt\\\" version=\\\"1.1\\\" viewbox=\\\"27.221183800000002 -8.6359 28.182 9.2729\\\" width=\\\"28.182pt\\\" xmlns=\\\"http://www.w3.org/2000/svg\\\" xmlns:xlink=\\\"http://www.w3.org/1999/xlink\\\"><g transform=\\\"matrix(.013,0,0,-0.013,27.271,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,33.511,0)\\\"><use xlink:href=\\\"#g113-47\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,36.475,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,42.715,0)\\\"><use xlink:href=\\\"#g113-49\\\"></use></g><g transform=\\\"matrix(.013,0,0,-0.013,48.955,0)\\\"></path></g></svg>).</span></span> Two patients (4.2%) developed intraocular inflammation. <i>Conclusion</i>. Switching to brolucizumab from aflibercept for eyes with nAMD with resistance to bimonthly injections of aflibercept is a valuable treatment option with and without the loading regimen. 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引用次数: 0

摘要

目的评估对阿夫利拜特耐药的新生血管性年龄相关性黄斑变性(nAMD)患者转用博路单抗一年的疗效,包括是否采用负荷剂量方案(每月注射三次)。研究方法我们回顾性研究了在每两个月注射一次阿弗利百普的情况下出现视网膜渗出,并从阿弗利百普转为使用博路单抗的 nAMD 患者。我们将患者分为有负荷剂量方案的玻璃体内注射(IVBr)(负荷组)和无负荷剂量方案的(非负荷组)。我们评估了最佳矫正视力(BCVA)、眼窝处视网膜中心厚度(CRT)、眼底脉络膜厚度(SFCT)、IVBr状态(注射次数和最后一次注射间隔时间)以及光学相干断层扫描上的视网膜渗出状况。结果。52只眼睛接受了≥1次IVBr注射;26只眼睛接受了≥3次IVBr注射,随访12个月。共对加载组和非加载组的 13 只眼睛进行了复查。换眼一年后,加载组()的 BCVA 从 0.28 ± 0.25 变为 0.19 ± 0.28,非加载组()的 BCVA 从 0.25 ± 0.20 变为 0.23 ± 0.25。加载组()的平均 CRT 从 263.6 ± 40.7 µm 降至 221.7 ± 54.6 µm,而非加载组()的平均 CRT 仅从 244.9 ± 77.2 µm 降至 221.0 ± 78.7 µm。负荷组和非负荷组的黄斑干度都达到了 69%。负荷组的注射次数明显高于非负荷组(7.6 ± 0.6 对 6.8 ± 0.4)。两名患者(4.2%)出现眼内炎症。结论对于对每两个月注射一次阿弗利贝赛耐药的nAMD患者,从阿弗利贝赛改用brolucizumab是一种有价值的治疗方案,无论是否使用负荷疗法。该试验的注册号为 UMIN000023676。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Effect of a Loading Dose Regimen in the Switch to Brolucizumab for Patients with Aflibercept-Resistant nAMD
Purpose. To evaluate the one-year outcomes of switching to brolucizumab with and without a loading dose regimen (three monthly injections) in eyes with aflibercept-resistant neovascular age-related macular degeneration (nAMD). Methods. We retrospectively studied nAMD patients who had retinal exudate under bimonthly injections of aflibercept and were switched to brolucizumab from aflibercept. Patients were grouped into intravitreal brolucizumab injection (IVBr) with a loading dose regimen (loading group) and without a loading dose regimen (nonloading group). We assessed the best-corrected visual acuity (BCVA), central retinal thickness (CRT) at the fovea, subfoveal choroidal thickness (SFCT), IVBr status (number of injections and last injection interval), and retinal exudate status on optical coherence tomography. Results. Overall, 52 eyes received ≥1 IVBr; 26 eyes received ≥3 IVBr with 12-month follow-up. A total of 13 eyes in the loading group and 13 eyes in the nonloading group were reviewed. One year after switching, BCVA changed from 0.28 ± 0.25 to 0.19 ± 0.28 in the loading group () and from 0.25 ± 0.20 to 0.23 ± 0.25 in the nonloading group (). The mean CRT decreased from 263.6 ± 40.7 µm to 221.7 ± 54.6 µm in the loading group (), while it only changed from 244.9 ± 77.2 µm to 221.0 ± 78.7 µm in the nonloading group (). Both the loading and nonloading groups achieved 69% dry macula. The number of injections received was significantly higher in the loading group (7.6 ± 0.6 vs. 6.8 ± 0.4, ). Two patients (4.2%) developed intraocular inflammation. Conclusion. Switching to brolucizumab from aflibercept for eyes with nAMD with resistance to bimonthly injections of aflibercept is a valuable treatment option with and without the loading regimen. This trial is registered with UMIN000023676.
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来源期刊
Journal of Ophthalmology
Journal of Ophthalmology MEDICINE, RESEARCH & EXPERIMENTAL-OPHTHALMOLOGY
CiteScore
4.30
自引率
5.30%
发文量
194
审稿时长
6-12 weeks
期刊介绍: Journal of Ophthalmology is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to the anatomy, physiology and diseases of the eye. Submissions should focus on new diagnostic and surgical techniques, instrument and therapy updates, as well as clinical trials and research findings.
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