Ranibizumab and Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration Two-Year Results
Ranibizumab and Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration Two-Year Results
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DOI：
10.1016/j.ophtha.2020.01.029
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发表时间：
2020-04-01
期刊：
影响因子：
13.7
通讯作者：
Ferris, Frederick L.
中科院分区：
文献类型：
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作者：
Martin, Daniel F.;Maguire, Maureen G.;Ferris, Frederick L.
目的：描述雷珠单抗和贝伐单抗每月或按需给药2年的效果，并描述每月治疗1年后转为按需治疗的影响。设计：多中心，随机临床试验。参与者：患者（n = 1107）在第2年对1185例新生血管年龄-干预：在招募时，将患者分配到由药物（雷珠单抗或贝伐单抗）和给药方案（每月或根据需要）定义的4个治疗组。在1年时，最初分配到每月治疗的患者被随机重新分配到每月或按需治疗，而不改变药物分配。主要结果测量：视力的平均变化。结果：在遵循相同方案2年的患者中，两种药物的视力平均增加相似（贝伐珠单抗-雷珠单抗差异，-1.4个字母; 95%置信区间[CI]，-3.7至0.8; P = 0.21）。每月治疗的平均增益大于按需治疗（差异，-2.4个字母; 95% CI，-4.8至-0.1; P = 0.046）。无液体的比例范围从贝伐珠单抗按需组的13.9%到雷珠单抗每月组的45.5%（药物，P = 0.0003;方案，P < 0.0001）。从每月一次转换为按需治疗导致第2年视力平均下降更大（-2.2个字母; P = 0.03），无液体的比例更低（-19%; P < 0.0001）。两种药物的死亡率和动脉血栓事件发生率相似（P > 0.60）。贝伐珠单抗组发生1起或多起系统性严重不良事件的患者比例高于雷珠单抗组（39.9% vs. 31.7%;校正风险比，1.30; 95%CI，1.07-1.57; P = 0.009）。大多数的过剩事件并没有与以前的系统治疗靶向血管内皮生长因子（VEGF）。结论：雷珠单抗和贝伐单抗在2年的时间内对视力有类似的影响。无论是在入组时还是在每月治疗1年后，按需治疗导致视力增加较少。两种药物在死亡率或动脉血栓事件方面没有差异。由于缺乏对VEGF抑制相关疾病的特异性，贝伐珠单抗严重不良事件发生率持续较高的解释尚不确定。(C)2012年由美国眼科学会。
Objective: To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment.Design: Multicenter, randomized clinical trial.Participants: Patients (n = 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial.Interventions: At enrollment, patients were assigned to 4 treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At 1 year, patients initially assigned to monthly treatment were reassigned randomly to monthly or as-needed treatment, without changing the drug assignment.Main Outcome Measures: Mean change in visual acuity.Results: Among patients following the same regimen for 2 years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference, -1.4 letters; 95% confidence interval [CI], -3.7 to 0.8; P = 0.21). Mean gain was greater for monthly than for as-needed treatment (difference, -2.4 letters; 95% CI, -4.8 to -0.1; P = 0.046). The proportion without fluid ranged from 13.9% in the bevacizumab-as-needed group to 45.5% in the ranibizumab monthly group (drug, P = 0.0003; regimen, P < 0.0001). Switching from monthly to as-needed treatment resulted in greater mean decrease in vision during year 2 (-2.2 letters; P = 0.03) and a lower proportion without fluid (-19%; P < 0.0001). Rates of death and arteriothrombotic events were similar for both drugs (P > 0.60). The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; P = 0.009). Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF).Conclusions: Ranibizumab and bevacizumab had similar effects on visual acuity over a 2-year period. Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment. There were no differences between drugs in rates of death or arteriothrombotic events. The interpretation of the persistence of higher rates of serious adverse events with bevacizumab is uncertain because of the lack of specificity to conditions associated with inhibition of VEGF. (C) 2012 by the American Academy of Ophthalmology.