Chong V
Oxford Eye Hospital, Oxford University Hospitals, Oxford, UK.
Eye (Lond). 2016 Feb;30(2):270-86. doi: 10.1038/eye.2015.217. Epub 2015 Dec 4.
Data from real-world studies of ranibizumab in neovascular (wet) age-related macular degeneration suggest that outcomes in clinical practice fail to match those seen in clinical trials. These real-world studies follow treatment regimens that differ from the fixed dosing used in the pivotal clinical trial programme. To better understand the effectiveness of ranibizumab in clinical practice, we conducted a comprehensive evaluation of 12-month outcomes reported in peer-reviewed 'real-world' publications. Key measures included in our analysis were mean change in visual acuity (VA) and the proportion of patients gaining ≥15 letters or losing ≤15 letters. Twenty studies were eligible for inclusion in our study, with 18 358 eyes having sufficient data for analysis of 12-month outcomes. Mean baseline VA ranged from 48.8 to 61.6 Early Treatment Diabetic Retinopathy Study letters. Mean change in VA was between -2.0 and +5.5 letters, with a grand mean of +2.9±3.2, and a weighted mean (adjusted for the number of eyes in the study) of +1.95. Eleven studies reported that 19±7.5 (mean value) of patients gained ≥15 letters, while in 12 studies the mean percentage of patient losing ≤15 letters was 89±6.5%. Our comprehensive analysis of real-world ranibizumab study data confirm that patient outcomes are considerably poorer than those reported in randomised control trials of both fixed and pro re nata regimens.
雷珠单抗治疗新生血管性(湿性)年龄相关性黄斑变性的真实世界研究数据表明,临床实践中的治疗结果未能达到临床试验中的效果。这些真实世界研究采用的治疗方案与关键临床试验项目中使用的固定剂量不同。为了更好地了解雷珠单抗在临床实践中的有效性,我们对同行评审的“真实世界”出版物中报告的12个月治疗结果进行了全面评估。我们分析中纳入的关键指标包括视力(VA)的平均变化以及视力提高≥15个字母或降低≤15个字母的患者比例。有20项研究符合纳入我们研究的条件,其中18358只眼睛有足够的数据用于分析12个月的治疗结果。平均基线视力范围为48.8至61.6个早期糖尿病性视网膜病变研究字母。视力的平均变化在-2.0至+5.5个字母之间,总体平均值为+2.9±3.2,加权平均值(根据研究中的眼睛数量进行调整)为+1.95。11项研究报告称,19±7.5(平均值)的患者视力提高≥15个字母,而在12项研究中,视力降低≤15个字母的患者平均百分比为89±6.5%。我们对雷珠单抗真实世界研究数据的全面分析证实,患者的治疗结果比固定剂量和按需治疗方案的随机对照试验报告的结果要差得多。