Associated Retinal Consultants, Royal Oak, Michigan.
American Academy of Ophthalmology, San Francisco, California.
Ophthalmology. 2018 Apr;125(4):522-528. doi: 10.1016/j.ophtha.2017.10.010. Epub 2017 Nov 13.
The purpose of this study is to compare real-world visual acuity (VA) in patients with neovascular age-related macular degeneration (nAMD) treated with a single anti-vascular endothelial growth factor (VEGF) drug monotherapy for 1 year from the American Academy of Ophthalmology (AAO) Intelligent Research in Sight (IRIS) Registry.
Retrospective, nonrandomized, comparative study.
IRIS Registry patients with nAMD who received bevacizumab, ranibizumab, or aflibercept only for 1 year between 2013-2016.
Participants were divided into 3 groups based on monotherapy type. Multivariate analysis of covariance models (ANCOVA) was constructed in a stepwise fashion.
The logarithm of the minimum angle of resolution (logMAR) VA at 1 year and mean change in logMAR VA between baseline and 1 year were compared between drug types.
Of 13 859 patients, 6723 received bevacizumab, 2749 received ranibizumab, and 4387 received aflibercept only for 1 year. A total of 84 828 injections were performed. The mean number of injections (standard deviation) at 1 year was higher in the ranibizumab (6.4 [±2.4]) and aflibercept groups (6.2 [±2.4]) compared to bevacizumab group (5.9 [±2.4]; P < 0.0001). In the age-adjusted model, both ranibizumab and aflibercept achieved better logMAR VA at 1 year compared with bevacizumab (0.50 [±0.49], 0.49 [±0.44], 0.55 [±0.57]; P < 0.0001). However, this difference was not significant after multivariate adjustment (age, baseline VA, diabetes, posterior vitreous detachment, number of injections, race, insurance). There was no statistical difference in the age-adjusted or multivariate-adjusted mean logMAR VA change (standard deviation) at 1 year among treatment groups (-0.048 [0.44] bevacizumab, -0.053 [0.46] ranibizumab, -0.040 [0.39] aflibercept; P = 0.46). A higher percentage of patients achieved a ≥3-line VA improvement at 1 year in the bevacizumab group (22.7%) compared with ranibizumab (20.1%; P = 0.0093) and aflibercept (17.8%; P < 0.0001). However, after multivariate adjustment, aflibercept exhibited a greater log odds of a ≥3-line VA loss compared with bevacizumab only (1.25 log odds ratio; P < 0.0016).
This study suggests that all 3 drugs improve VA similarly over 1 year of monotherapy.
本研究旨在比较接受单种抗血管内皮生长因子（VEGF）药物治疗的新生血管性年龄相关性黄斑变性（nAMD）患者的真实世界视力（VA），这些患者来自美国眼科学会（AAO）智能研究中的视野（IRIS）登记处，接受治疗的时间为 1 年。
回顾性、非随机、比较研究。
IRIS 登记处 2013-2016 年间接受贝伐单抗、雷珠单抗或阿柏西普单药治疗 1 年的 nAMD 患者。
根据单药类型将患者分为 3 组。采用逐步法构建协方差模型（ANCOVA）的多变量分析。
1 年时最小分辨角对数（logMAR）VA 的对数和基线至 1 年时 logMAR VA 的平均变化在药物类型之间进行比较。
在 13859 例患者中，6723 例接受贝伐单抗治疗，2749 例接受雷珠单抗治疗，4387 例接受阿柏西普单药治疗 1 年。共进行了 84828 次注射。雷珠单抗（6.4[±2.4]）和阿柏西普组（6.2[±2.4]）的 1 年平均注射次数（标准差）高于贝伐单抗组（5.9[±2.4]；P<0.0001）。在年龄调整模型中，与贝伐单抗相比，雷珠单抗和阿柏西普在 1 年时的 logMAR VA 均有更好的改善（0.50[±0.49]、0.49[±0.44]、0.55[±0.57]；P<0.0001）。然而，在多变量调整后（年龄、基线 VA、糖尿病、后玻璃体脱离、注射次数、种族、保险），这种差异无统计学意义。在治疗组中，1 年时年龄调整或多变量调整的平均 logMAR VA 变化（标准差）无统计学差异（贝伐单抗组-0.048[0.44]，雷珠单抗组-0.053[0.46]，阿柏西普组-0.040[0.39]；P=0.46）。在 1 年时，贝伐单抗组有更高比例的患者 VA 改善≥3 行（22.7%），高于雷珠单抗组（20.1%；P=0.0093）和阿柏西普组（17.8%；P<0.0001）。然而，在多变量调整后，与贝伐单抗相比，阿柏西普在 1 年时的 log 优势比更有可能导致 VA 损失≥3 行（1.25 log 优势比；P<0.0016）。
本研究表明，这 3 种药物在 1 年的单药治疗中均能同样改善 VA。
