Yang Yit, Downey Louise, Mehta Hemal, Mushtaq Bushra, Narendran Niro, Patel Nishal, Patel Praveen J, Ayan Filis, Gibson Kara, Igwe Franklin, Jeffery Pete
Wolverhampton Eye Infirmary, Wolverhampton, UK.
School of Health and Life Sciences, Aston University, Birmingham, UK.
Ophthalmol Ther. 2017 Jun;6(1):175-186. doi: 10.1007/s40123-017-0091-9. Epub 2017 May 15.
Ranibizumab is an inhibitor of vascular endothelial growth factor-A (anti-VEGF) approved for the treatment of neovascular age-related macular degeneration (nAMD). The treat and extend (T&E) regimen can potentially reduce the burden of clinic visits compared with a pro re nata (PRN) regimen. Retrospective, interim analyses of clinical effectiveness, treatment and resource use patterns were conducted using real-world data in England and Wales from the TERRA study.
Two cohorts, those switching from a PRN to a T&E regimen ('prior PRN') and those initiating ranibizumab on the T&E regimen as their first anti-VEGF therapy ('anti-VEGF-naïve') were enrolled in TERRA. Retrospective clinical assessments were gathered from medical records, while resource use patterns were collected via an operating cost questionnaire completed by each study site.
At the interim analysis cut-off date (15 November 2016), 11 sites had enrolled 145 patients (prior PRN: n = 110; anti-VEGF-naïve: n = 35). Mean change from baseline (date of first injection) in visual acuity and central subfield retinal thickness to 12 months was +7.6 Early Treatment Diabetic Retinopathy Study letters [95% confidence interval (CI) 2.8, 12.4; p = 0.003; n = 27] and -67.7 μm (95% CI -106.5, -28.9; p = 0.001, n = 29), respectively, in the anti-VEGF-naïve cohort. Most T&E clinics were run as one-stop services (same-day monitoring and injection), whereas 4/10 PRN clinics were run as two-stop services (monitoring and injection on different days). In general, one-stop clinics used less staff resources and were likely to be shorter in duration for healthcare providers than the cumulative time spent for two-stop clinics.
This is the first real-world observational study conducted in England and Wales demonstrating the effectiveness of the ranibizumab T&E regimen in anti-VEGF-naïve patients. T&E is compatible with one-stop clinic services, which these real-world data suggest to be less resource intensive than two-stop clinic services, possibly providing a dosing regimen beneficial to both patients and resource burden in UK clinical practice.
Novartis Pharmaceuticals UK Limited.
雷珠单抗是一种血管内皮生长因子-A抑制剂（抗VEGF），已被批准用于治疗新生血管性年龄相关性黄斑变性（nAMD）。与按需治疗（PRN）方案相比，治疗并延长（T&E）方案有可能减轻门诊负担。使用来自TERRA研究的英格兰和威尔士的真实世界数据，对临床疗效、治疗及资源使用模式进行了回顾性中期分析。
TERRA研究纳入了两个队列，即从PRN方案转换为T&E方案的患者（“既往PRN”）以及作为首次抗VEGF治疗开始使用雷珠单抗T&E方案的患者（“初治抗VEGF”）。从医疗记录中收集回顾性临床评估数据，同时通过每个研究地点完成的运营成本问卷收集资源使用模式数据。
在中期分析截止日期（2016年11月15日），11个研究地点共纳入了145例患者（既往PRN：n = 110；初治抗VEGF：n = 35）。在初治抗VEGF队列中，从基线（首次注射日期）到12个月时，视力和中心子区域视网膜厚度的平均变化分别为+7.6个早期糖尿病视网膜病变研究字母单位[95%置信区间（CI）2.8，12.4；p = 0.003；n = 27]和-67.7μm（95%CI -106.5，-28.9；p = 0.001，n = 29）。大多数T&E诊所作为一站式服务运行（同日监测和注射），而10个PRN诊所中有4个作为两站式服务运行（不同日监测和注射）。总体而言，一站式诊所使用的人力资源较少，对于医疗服务提供者来说，其持续时间可能比两站式诊所的累计时间更短。
这是在英格兰和威尔士进行的第一项真实世界观察性研究，证明了雷珠单抗T&E方案在初治抗VEGF患者中的有效性。T&E与一站式诊所服务兼容，这些真实世界数据表明，一站式诊所服务的资源密集程度低于两站式诊所服务，这可能为英国临床实践中的患者和资源负担提供一种有益的给药方案。
诺华制药英国有限公司。
