Queguiner Frederic, Bezirganyan Kristina, Courjaret Jean Christophe, Curel Laurence, Penaranda Guillaume, Righini Chossegros Maud
Ophthalmology and Clinical Research Departments, Hôpital Saint Joseph, Marseille F-13008, France.
Biostatistics Department, Alphabio Laboratory, Marseille F-13003, France.
Int J Ophthalmol. 2020 Feb 18;13(2):252-256. doi: 10.18240/ijo.2020.02.08. eCollection 2020.
To study if one of the two molecules could lead to a lower number of follow up visits and intra-vitreous injection (IVI) with the same efficacy.
ELU (or "elected" in French) study is a retrospective study conducted in real life in patients presenting suboptimal response after ranibizumab IVI (phase 1) and secondary switched to aflibercept (phase 2). The number of follow up visits and IVI were compared in both phases. Visual acuity (VA) evolution and "switching" reasons were secondary analyzed.
We retrospectively included data of 33 patients (38 eyes) with age-related macular degeneration (AMD; mean age: 77±7.7y). The number of monthly follow up visits [median (Q1; Q3)]: was significantly lower with aflibercept (phase 2), respectively 1.0 (0.81; 1.49) visits in phase 1, versus 0.79 (0.67; 0.86) visits in phase 2. The median number of monthly IVI also significantly decreased in phase 2, respectively 0.67 (0.55; 0.90) IVI in phase 1, versus 0.55 (0.45; 0.67) IVI in phase 2. The mean VA evolution (VA final-VA initial) was similar in both phases, (>0.05). Whatever the reason for "switching" (loss of efficacy, tachyphylaxis, tolerance problems), there was no incidence on VA evolution over the time.
Our results show that switching from ranibizumab to aflibercept in "suboptimal" patients significantly reduce the number of follow up visits and IVI, with a comparable efficacy. This decrease in visit number could improve patients' quality of life and reduce surgical risk by reducing the number of injections.
研究两种分子中的一种是否能在疗效相同的情况下减少随访次数和玻璃体内注射(IVI)的次数。
ELU(法语中意为“选定的”)研究是一项在现实生活中对接受雷珠单抗玻璃体内注射(第1阶段)后反应欠佳且随后改用阿柏西普(第2阶段)的患者进行的回顾性研究。比较了两个阶段的随访次数和玻璃体内注射次数。对视力(VA)变化和“换药”原因进行了次要分析。
我们回顾性纳入了33例年龄相关性黄斑变性(AMD;平均年龄:77±7.7岁)患者(38只眼)的数据。每月随访次数的中位数[四分位数间距(Q1;Q3)]:阿柏西普组(第2阶段)显著更低,第1阶段分别为1.0(0.81;1.49)次随访,而第2阶段为0.79(0.67;0.86)次随访。每月玻璃体内注射次数的中位数在第2阶段也显著减少,第1阶段分别为0.67(0.55;0.90)次注射,而第2阶段为0.55(0.45;0.67)次注射。两个阶段的平均视力变化(最终视力 - 初始视力)相似(>0.05)。无论“换药”原因是什么(疗效丧失、快速耐受、耐受性问题),随着时间推移对视力变化均无影响。
我们的结果表明,在“反应欠佳”的患者中从雷珠单抗改用阿柏西普可显著减少随访次数和玻璃体内注射次数,且疗效相当。随访次数的减少可通过减少注射次数改善患者生活质量并降低手术风险。