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Meta-Analysis
. 2023 Jan;37(1):6-16.
doi: 10.1038/s41433-022-02020-7. Epub 2022 Apr 8.

Efficacy, safety, and treatment burden of treat-and-extend versus alternative anti-VEGF regimens for nAMD: a systematic review and meta-analysis

Affiliations
Meta-Analysis

Efficacy, safety, and treatment burden of treat-and-extend versus alternative anti-VEGF regimens for nAMD: a systematic review and meta-analysis

Daniel Rosenberg et al. Eye (Lond). 2023 Jan.

Abstract

This study aimed to compare efficacy and treatment burden of treat-and-extend (T&E) anti-VEGF against fixed and pro re nata (PRN) regimens for neovascular age-related macular degeneration (nAMD). MEDLINE, CENTRAL, and EMBASE were searched. Randomized-controlled trials and observational studies comparing T&E to PRN or fixed dosing for treatment-naïve AMD patients were included. Mean difference (MD) for visual acuity (VA) and number of injections are presented. Risk of bias was assessed according to Cochrane guidelines. Methodology was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). VA improvement was similar with T&E and fixed dosing at one (MD -0.08 letters, p = 0.95) and two years (MD 0.58 letters, p = 0.62). In contrast, VA improvements were significantly greater for T&E when compared against a PRN regimen at one (MD 3.95 letters, p < 0.0001) and two years (MD 4.08 letters, p < 0.001). Significantly fewer ranibizumab injections were administered in the T&E arm at one (MD -2.42 injections, p < 0.0001) and two years (MD -6.06 injections, p < 0.00001) relative to fixed dosing. Fewer aflibercept injections were likewise administered to patients on a T&E regimen versus fixed dosing at one year (MD -0.78 injections, p < 0.0001). Low-certainty evidence from the present synthesis implies that T&E preserves VA similar to fixed schedules with significantly fewer injections at one and two years. Also, patients with T&E dosing achieved better VA outcomes than those on PRN regimen but T&E dosing was associated with more injections.

摘要: 本研究旨在比较治疗-延长(T&E)方案的抗VEGF给药与固定剂量和按需(PRN)方案的给药对新生血管性年龄相关黄斑变性的疗效和治疗负担。我们搜索了MEDLINE, CENTRAL和 EMBASE数据库, 纳入了比较T&E与PRN或固定剂量给药初治AMD患者的随机对照试验和观察性研究。这些研究中均包含了视力(VA)的平均差异(MD)和注射次数的信息。我们根据Cochrane指南评估偏倚风险, 参照系统综述和荟萃分析的首选报告条目(PRISMA)进行了方法学分析。T&E和固定剂量给药对于视力改善的程度在1年(MD −0.08 个字母, p = 0.95)和2年 (MD 0.58 个字母, p = 0.62)内是相似的。然而, 与PRN方案相比, T&E方案在1年(MD 3.95个字母, p < 0.0001)和2年(MD 4.08个字母, p < 0.001)里对视力有显著改善。与固定剂量给药相比, T&E给药在1年(MD–2.42次注射, p < 0.0001)和2年(MD–6.06次注射, p < 0.00001)里的雷珠单抗注射次数显著减少。同时, 相较于固定剂量给药, 在1年里采用T&E给药的患者接受阿柏西普注射的次数更少(MD −0.78次注射, p < 0.0001)。目前低等级的证据显示, T&E对视力的改善与固定剂量给药相似, 但在1年和2年里的注射药物次数却显著减少。此外, T&E给药对患者的视力改善优于PRN方案, 但T&E方案的药物注射次数却较多。.

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Conflict of interest statement

SS reports receiving research grants from Novartis, Bayer, Allergan, Roche, Boehringer, Ingelheim and Optos Plc, Travel grants from Novartis, Bayer, speaker fees from Novartis, Bayer and Optos Plc, and attending advisory board meetings for Novartis, Bayer, Allergan, Roche, Boehringer, Ingelheim, Optos Plz, Oxurion, Ophthea, Apellis, Oculis and Heidelberg Engineering. CMGC reports grants and speaker fees from Roche, Novartis, Bayer, Allergan, and Topcon outside the submitted work. DS has acted as consultant for Amgen, Bayer, Genentech, Novartis, and Optovue, and reports grants from Amgen, Genentech, Heidelberg, Optovue, Regeneron and Topcon, outside the submitted work. SJB has acted as a consultant for Adverum, Alimera, Apellis, Allergan, Eyepoint, Kala, Genentech, Novartis, Oxurion, Roche, and Zeiss, outside the submitted work. CCW reported consulting for Acuela, Adverum Biotechnologies, Inc, Aerpio, Alimera Sciences, Allegro Ophthalmics, LLC, Allergan, Apellis Pharmaceuticals, Bayer AG, Chengdu Kanghong Pharmaceuticals Group Co, Ltd, Clearside Biomedical, DORC (Dutch Ophthalmic Research Center), EyePoint Pharmaceuticals, Gentech/Roche, GyroscopeTx, IVERIC bio, Kodiak Sciences Inc, Novartis AG, ONL Therapeutics, Oxurion NV, PolyPhotonix, Recens Medical, Regeron Pharmaceuticals, Inc, REGENXBIO Inc, Santen Pharmaceutical Co, Ltd, and Takeda Pharmaceutical Company Limited and receiving research funding from Adverum Biotechnologies, Inc, Aerie Pharmaceuticals, Inc, Aerpio, Alimera Sciences, Allergan, Apellis Pharmaceuticals, Chengdu Kanghong Pharmaceutical Group Co, Ltd, Clearside Biomedical, Gemini Therapeutics, Genentech/Roche, Graybug Vision, Inc, GyroscopeTx, Ionis Pharmaceuticals, IVERIC bio, Kodiak Sciences Inc, Neurotech LLC, Novartis AG, Opthea, Outlook Therapeutics, Inc, Recens Medical, Regeneron Pharmaceuticals, Inc, REGENXBIO Inc, Samsung Pharm Co, Ltd, Santen Pharmaceutical Co, Ltd, and Xbrane Biopharma AB. VC reports acting as an advisory board member, grants and other from Novartis, acting as an advisory board member, grants and other from Bayer, grants from Allergan, and acting as an advisory board member for Roche, outside the submitted work. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Forest plots for visual, anatomical, treatment burden, and adverse event outcomes compared between T&E and alternative anti-VEGF dosing regimens.
Forest plots are presented for all meta-analyses, including visual, anatomical, treatment burden, and adverse events compared between T&E and alternative dosing regimens. Funnel plots or other tests of publication bias were deferred due to the low number of included studies. T&E treat-and-extend, VEGF vascular endothelial growth-factor agent, PRN pro-re-nata.
Fig. 1
Fig. 1. Forest plots for visual, anatomical, treatment burden, and adverse event outcomes compared between T&E and alternative anti-VEGF dosing regimens.
Forest plots are presented for all meta-analyses, including visual, anatomical, treatment burden, and adverse events compared between T&E and alternative dosing regimens. Funnel plots or other tests of publication bias were deferred due to the low number of included studies. T&E treat-and-extend, VEGF vascular endothelial growth-factor agent, PRN pro-re-nata.
Fig. 1
Fig. 1. Forest plots for visual, anatomical, treatment burden, and adverse event outcomes compared between T&E and alternative anti-VEGF dosing regimens.
Forest plots are presented for all meta-analyses, including visual, anatomical, treatment burden, and adverse events compared between T&E and alternative dosing regimens. Funnel plots or other tests of publication bias were deferred due to the low number of included studies. T&E treat-and-extend, VEGF vascular endothelial growth-factor agent, PRN pro-re-nata.
Fig. 1
Fig. 1. Forest plots for visual, anatomical, treatment burden, and adverse event outcomes compared between T&E and alternative anti-VEGF dosing regimens.
Forest plots are presented for all meta-analyses, including visual, anatomical, treatment burden, and adverse events compared between T&E and alternative dosing regimens. Funnel plots or other tests of publication bias were deferred due to the low number of included studies. T&E treat-and-extend, VEGF vascular endothelial growth-factor agent, PRN pro-re-nata.

References

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