Efficacy of treatment of MS with IFNβ-1b or glatiramer acetate by monthly brain MRI in the BECOME study
Efficacy of treatment of MS with IFNβ-1b or glatiramer acetate by monthly brain MRI in the BECOME study
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DOI：
10.1212/01.wnl.0000345970.73354.17
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发表时间：
2009-06-09
期刊：
影响因子：
9.9
通讯作者：
Cook, S. D.
中科院分区：
文献类型：
--
作者：
Cadavid, D.;Wolansky, L. J.;Cook, S. D.
背景：没有已发表的MRI研究比较干扰素β 1b （IFN β 1b）和醋酸格拉替默（GA）治疗复发性多发性硬化症（MS）。目的：比较IFN β -1b和GA对多发性硬化症疾病活动的抑制作用。方法：共有75名复发缓解型多发性硬化或临床孤立综合征患者被随机分配到标准剂量的IFN β -1b或GA，并随访长达2年的每月脑MRI，优化方案以检测增强。主要结果是第一年每位患者每次扫描的合并活动性病变（CAL）的数量，包括所有增强病变和非增强的新T2/液体衰减反转恢复（FLAIR）病变。次要结果是2年内新病变和临床恶化的数量。结果：两组间基线特征相似。主要结局显示1-12个月每位患者每次扫描的中位数（75个百分点）CAL相似，IFN β -1b为0.63 (2.76)，GA为0.58 (2.45)（p = 0.58）。两组在2年内的新发病变和临床复发率均无差异。每月MRI扫描中只有4.4%的CAL是非增强的T2/FLAIR新病变。结论：随机接受干扰素β 1b或醋酸格拉替默治疗的复发性多发性硬化症患者表现出相似的MRI和临床活性。神经病学(R) 2009；72: 1976 - 1983
Background: There are no published MRI studies comparing interferon beta 1b (IFN beta-1b) and glatiramer acetate (GA) for treatment of relapsing multiple sclerosis (MS).Objective: To compare the efficacy of IFN beta-1b and GA for suppression of MS disease activity as evidenced on frequent brain MRI.Methods: A total of 75 patients with relapsing-remitting MS or clinically isolated syndromes were randomized to standard doses of IFN beta-1b or GA and followed by monthly brain MRI for up to 2 years with a protocol optimized to detect enhancement. The primary outcome was the number of combined active lesions (CAL) per patient per scan during the first year, which included all enhancing lesions and nonenhancing new T2/fluid-attenuated inversion recovery (FLAIR) lesions. Secondary outcomes were the number of new lesions and clinical exacerbations over 2 years.Results: Baseline characteristics were similar between the groups. The primary outcome showed similar median (75th percentile) CAL per patient per scan for months 1-12, 0.63 (2.76) for IFN beta-1b, and 0.58 (2.45) for GA (p = 0.58). There were no differences in new lesion or clinical relapses for 2 years. Only 4.4% of CAL on monthly MRI scans were nonenhancing new T2/FLAIR lesions.Conclusion: Patients with relapsing multiple sclerosis randomized to interferon beta 1b or glatiramer acetate showed similar MRI and clinical activity. Neurology (R) 2009; 72: 1976-1983