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.
复制标题
DOI：
10.1016/j.ophtha.2012.03.053
复制
发表时间：
2012-07
期刊：
影响因子：
13.7
通讯作者：
Ferris FL 3rd
中科院分区：
文献类型：
--
作者：
Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group;Martin DF;Maguire MG;Fine SL;Ying GS;Jaffe GJ;Grunwald JE;Toth C;Redford M;Ferris FL 3rd
描述雷珠单抗和贝伐珠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。多中心、随机临床试验。在入组临床试验的1185例新生血管性年龄相关性黄斑变性（AMD）患者中，在第2年随访的患者（N=1107）。在招募时，患者被分配到四个治疗组，根据药物（雷珠单抗或贝伐单抗）和给药方案（每月或根据需要）定义。在一年时，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。视力的平均变化。在接受相同治疗方案两年的患者中，两种药物的视力平均增益相似（贝伐珠单抗-雷珠单抗差异：-1.4个字母; 95%置信区间（CI）：[-3.7，0.8]; 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; CI：[-4.8，-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%到雷珠单抗每月一次组的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; CI [1.07，1.57]; p=0.009）。大多数过量事件与既往靶向血管内皮生长因子（VEGF）的全身治疗无关。雷珠单抗和贝伐单抗在两年的时间内对视力的影响相似。无论是在入组时还是在每月治疗一年后，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。
To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for two years and to describe the impact of switching to as-needed treatment after a year of monthly treatment. Multicenter, randomized clinical trial. Patients (N=1107) who were followed during Year 2 among 1185 patients with neovascular age-related macular degeneration (AMD) who were enrolled in the clinical trial. At enrollment, patients were assigned to four treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At one year, patients initially assigned to monthly treatment were randomly reassigned to monthly or as needed treatment, without changing the drug assignment. Mean change in visual acuity. Among patients following the same regimen for two years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference: −1.4 letters; 95% confidence interval (CI): [−3.7, 0.8]; p=0.21). Mean gain was greater for monthly than for as-needed treatment (difference: −2.4 letters; CI: [−4.8, −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 systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio 1.30; CI [1.07, 1.57]; p=0.009). The majority of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF). Ranibizumab and bevacizumab had similar effects on visual acuity over a two-year period. Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after one 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.
登录
查看更多内容
影响因子：
158.5
作者：
Brown, David M.;Kaiser, Peter K.;Schneider, Susan
通讯作者：
Schneider, Susan
影响因子：
158.5
作者：
Rosenfeld, Philip J.;Brown, David M.;Kim, Robert Y.
通讯作者：
Kim, Robert Y.
影响因子：
4.2
作者：
Brechner, Ross J.;Rosenfeld, Philip J.;Caplan, Stuart
通讯作者：
Caplan, Stuart
影响因子：
13.7
作者：
Fish, G;Haller, JA;Patel, S
通讯作者：
Patel, S
DOI：
10.1056/nejmoa1102673
发表时间：
2011-05-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
CATT Research Group;Martin DF;Maguire MG;Ying GS;Grunwald JE;Fine SL;Jaffe GJ
通讯作者：
Jaffe GJ