Barkhof Frederik, Polman Chris H, Radue Ernst-Wilhelm, Kappos Ludwig, Freedman Mark S, Edan Gilles, Hartung Hans-Peter, Miller David H, Montalbán Xavier, Poppe Peter, de Vos Marlieke, Lasri Fatiha, Bauer Lars, Dahms Susanne, Wagner Klaus, Pohl Christoph, Sandbrink Rupert
Department of Diagnostic Radiology and Image Analysis Center, Vrije Universiteit Medical Center, PO Box 7057, 1007 MB Amsterdam, the Netherlands.
Arch Neurol. 2007 Sep;64(9):1292-8. doi: 10.1001/archneur.64.9.1292.
In the Betaseron/Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study, interferon beta-1b delayed conversion to multiple sclerosis in patients with a first clinical event and at least 2 clinically silent brain magnetic resonance imaging (MRI) lesions.
To examine detailed MRI findings from the first 2 years of this trial.
Double-blind, placebo-controlled, randomized, parallel-group, multicenter, phase 3 study.
Ninety-eight centers worldwide.
A total of 404 individuals with a first demyelinating event suggestive of multiple sclerosis.
Patients were randomized to receive interferon beta-1b, 250 microg subcutaneously every other day, or placebo. After 24 months of treatment or on conversion to clinically definite multiple sclerosis, open-label interferon beta-1b treatment was offered.
Reported MRI data from patients completing 2 years of follow-up.
Data were analyzed from 248 patients taking interferon beta-1b and 156 taking placebo. Across 2 years the cumulative number of newly active lesions was lower in patients receiving interferon beta-1b vs placebo (median, 2.0 vs 5.0 [reduction of 60%]; P < .001). This corresponded to lower cumulative numbers of new T2 lesions (median, 1.0 vs 3.0 [reduction of 66%]; P < .001) and new gadolinium-enhancing lesions (median, 0.0 vs 1.0; P < .001) in patients receiving interferon beta-1b vs placebo. From screening to month 24, T2 lesion volume decreased and was more pronounced in patients receiving interferon beta-1b (P = .02).
Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group. This effect was maintained despite including patients who switched from placebo to interferon beta-1b in the active treatment group. Trial Registration clinicaltrials.gov Identifier: NCT00185211.
在“β-干扰素1b用于初发多发性硬化症的初始治疗（BENEFIT）”研究中，β-干扰素1b可延缓首次临床事件且至少有2个临床无症状脑磁共振成像（MRI）病灶的患者转化为多发性硬化症。
研究该试验前2年的详细MRI结果。
双盲、安慰剂对照、随机、平行组、多中心3期研究。
全球98个中心。
共404例首次出现提示多发性硬化症的脱髓鞘事件的个体。
患者被随机分配接受β-干扰素1b（隔日皮下注射250μg）或安慰剂。治疗24个月后或转化为临床确诊的多发性硬化症后，给予开放标签的β-干扰素1b治疗。
报告完成2年随访患者的MRI数据。
分析了248例接受β-干扰素1b治疗患者和156例接受安慰剂治疗患者的数据。在2年期间，接受β-干扰素1b治疗的患者新出现的活动性病灶累计数量低于接受安慰剂治疗的患者（中位数分别为2.0和5.0[减少60%]；P<.001）。这与接受β-干扰素1b治疗的患者新出现的T2病灶（中位数分别为1.0和3.0[减少66%]；P<.001）和新出现的钆增强病灶（中位数分别为0.0和1.0；P<.001）的累计数量较低相对应。从筛查到第24个月，T2病灶体积减小，在接受β-干扰素1b治疗的患者中更为明显（P=.02）。
β-干扰素1b治疗对MRI指标有显著影响，支持其作为该患者群体早期干预措施的价值。尽管在活性治疗组中纳入了从安慰剂转换为β-干扰素1b的患者，但这种效果仍然得以维持。试验注册 clinicaltrials.gov标识符：NCT00185211。
