Warwick Alasdair N, Leaver Hannah H, Lotery Andrew J, Goverdhan Srini V
Clinical Neurosciences Research Group, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, Hampshire, UK.; Southampton Eye Unit, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.
Clinical Neurosciences Research Group, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, Hampshire, UK.
Int J Ophthalmol. 2016 Aug 18;9(8):1156-62. doi: 10.18240/ijo.2016.08.12. eCollection 2016.
To determine real life clinical outcomes in poorly responsive and treatment-naïve neovascular age related macular degeneration (nvAMD) patients using bimonthly fixed dosing aflibercept regimen.
This was a retrospective study of 165 eyes with nvAMD started on aflibercept at Southampton Eye Unit between June 2013 and June 2014. Patients were either switched from pro re nata (PRN) ranibizumab/bevacizumab due to poor response (107 eyes), or treatment-naïve (58 eyes). Patients initially received 3-monthly intravitreal aflibercept injections followed by 2-monthly fixed doses. Clinic visits were scheduled at month 0, 4, 10 and 12. Mean change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline were assessed using the Wilcoxon signed-rank test. The proportion of patients maintaining BCVA (<15 letters loss) at 12mo was also evaluated.
Mean BCVA change at month 12 was +3.29 and +4.67 letters in the switched and naïve aflibercept groups respectively (P<0.01). BCVA was maintained in 95.3% of switched and 96.6% of naïve patients. CRT at month 12 showed a decrease of -6.16 µm in the switched group and -35.36 µm in the naïve group (P<0.01). Patients previously treated with ranibizumab/bevacizumab had on average received 7.4 ranibizumab/bevacizumab injections over 12.6mo, attending 10 clinic visits. The fixed dosing aflibercept regimen required an average of 7.1 injections (naïve group), 7.5 injections (switched group) and 4 clinic visits per year.
Fixed bimonthly aflibercept is effective in both treatment-naïve and poorly responsive nvAMD patients. Adopting a fixed dosing regimen can reduce patient burden without compromising on outcomes.
使用阿柏西普每两个月固定剂量给药方案,确定初治及抗治疗效果不佳的新生血管性年龄相关性黄斑变性(nvAMD)患者的实际临床疗效。
这是一项回顾性研究,对2013年6月至2014年6月间在南安普顿眼科中心开始接受阿柏西普治疗的165例nvAMD患者的眼睛进行研究。患者要么因抗治疗效果不佳从按需(PRN)雷珠单抗/贝伐单抗转换而来(107只眼),要么是初治患者(58只眼)。患者最初每3个月接受一次玻璃体内阿柏西普注射,随后每2个月接受固定剂量注射。在第0、4、10和12个月安排门诊就诊。使用Wilcoxon符号秩检验评估最佳矫正视力(BCVA)和视网膜中央厚度(CRT)相对于基线的平均变化。还评估了12个月时维持BCVA(视力下降<15个字母)的患者比例。
在转换治疗组和初治阿柏西普组中,第12个月时BCVA的平均变化分别为+3.29和+4.67个字母(P<0.01)。95.3%的转换治疗组患者和96.6%的初治患者维持了BCVA。第12个月时,转换治疗组的CRT下降了-6.16 µm,初治组下降了-35.36 µm(P<0.01)。先前接受雷珠单抗/贝伐单抗治疗的患者在12.6个月内平均接受了7.4次雷珠单抗/贝伐单抗注射,就诊10次。固定剂量阿柏西普给药方案平均每年需要注射7.1次(初治组)、7.5次(转换治疗组),并进行4次门诊就诊。
每两个月固定剂量的阿柏西普对初治及抗治疗效果不佳的nvAMD患者均有效。采用固定给药方案可减轻患者负担,且不影响治疗效果。