Danyliv Andriy, Glanville Julie, McCool Rachael, Ferreira Alberto, Skelly Adrian, Jacob Ruth Pulikottil
Novartis Ireland Limited, Dublin, Ireland.
York Health Economics Consortium, University of York, York, UK.
Adv Ther. 2017 Mar;34(3):611-619. doi: 10.1007/s12325-017-0484-0. Epub 2017 Feb 10.
Neovascular age-related macular degeneration (nAMD) is a chronic eye condition that causes severe deterioration of vision and ultimately blindness. Two vascular endothelial growth factor inhibitors are approved for nAMD treatment in Europe: ranibizumab and aflibercept. The European license for ranibizumab was updated with an individualized "treat and extend" (T&E) regimen, which involves more proactive treatment based on changes in best corrected visual acuity (BCVA) and/or anatomical outcomes. The aim of this publication is to compare the efficacy of the ranibizumab T&E regimen with other approved dosing regimens for nAMD on the basis of outcomes identified from a systematic review and subsequent NMA.
Following a systematic search of publications, to identify relevant studies, a repeated-measures network meta-analysis (NMA) was performed to estimate the relative effectiveness of ranibizumab T&E versus approved dosing regimens of ranibizumab and aflibercept. The analysis focused on licensed treatment regimens for nAMD. We examined mean change from baseline in BCVA on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
The systematic literature review identified 22,949 records, of which 23 studies were included in the NMA. At 12 months, the ranibizumab T&E dosing regimen vs ranibizumab pro re nata (PRN) was associated with small differences in change in BCVA, between 1.86 letter gain at 12 months and 2.35 letter gain at 24 months. A similar difference was observed in the aflibercept dosing regimen versus ranibizumab T&E ; 1.94 letter gain at 12 months and 3.31 letter gain at 24 months. All doses of ranibizumab and aflibercept showed similar effectiveness, and the differences between treatment options were not significant.
This study used novel repeated-measures NMA to synthesize efficacy results when treatment effects were reported at multiple follow-up times. This repeated-measures NMA suggests that treating patients with the ranibizumab T&E regimen yields similar effectiveness compared to other approved ranibizumab and aflibercept dosing regimens for nAMD treatment.
Novartis Pharmaceuticals UK Ltd, Surrey, UK.
新生血管性年龄相关性黄斑变性（nAMD）是一种慢性眼部疾病，可导致视力严重下降并最终失明。欧洲批准了两种血管内皮生长因子抑制剂用于治疗nAMD：雷珠单抗和阿柏西普。雷珠单抗在欧洲的许可更新为个体化的“治疗并延长”（T&E）方案，该方案基于最佳矫正视力（BCVA）和/或解剖学结果的变化进行更积极的治疗。本出版物的目的是根据系统评价和后续网络荟萃分析（NMA）确定的结果，比较雷珠单抗T&E方案与其他批准的nAMD给药方案的疗效。
在对出版物进行系统检索以识别相关研究后，进行了重复测量网络荟萃分析（NMA），以估计雷珠单抗T&E方案与雷珠单抗和阿柏西普批准给药方案的相对有效性。分析重点关注nAMD的许可治疗方案。我们在早期糖尿病视网膜病变研究（ETDRS）图表上检查了BCVA相对于基线的平均变化。
系统文献综述共识别出22949条记录，其中23项研究纳入了NMA。在12个月时，雷珠单抗T&E给药方案与雷珠单抗按需给药（PRN）相比，BCVA变化差异较小，12个月时增加1.86个字母，24个月时增加2.35个字母。阿柏西普给药方案与雷珠单抗T&E方案之间也观察到类似差异；12个月时增加1.94个字母，24个月时增加3.31个字母。所有剂量的雷珠单抗和阿柏西普显示出相似的有效性，治疗方案之间的差异不显著。
本研究使用了新颖的重复测量NMA来综合在多个随访时间报告治疗效果时的疗效结果。这种重复测量NMA表明，与其他批准的用于nAMD治疗的雷珠单抗和阿柏西普给药方案相比，采用雷珠单抗T&E方案治疗患者产生的效果相似。
诺华制药英国有限公司，英国萨里。
