Panitch H, Goodin D S, Francis G, Chang P, Coyle P K, O'Connor P, Monaghan E, Li D, Weinshenker B
University of Vermont College of Medicine, Burlington, VT 05401, USA.
Neurology. 2002 Nov 26;59(10):1496-506. doi: 10.1212/01.wnl.0000034080.43681.da.
Interferon beta (IFNbeta) reduces relapses and MRI activity in relapsing-remitting MS (RRMS), with variable effects on disability. The most effective dose regimen remains controversial.
This randomized, controlled, multicenter trial compared the efficacy and safety of IFNbeta-1a (Rebif) 44 micro g subcutaneously three times weekly (tiw), and IFNbeta-1a (Avonex) 30 micro g IM once weekly (qw) in 677 patients with RRMS. Assessors blinded to treatment performed neurologic and MRI evaluations. The primary endpoint was the proportion of patients who were relapse free at 24 weeks; the principal MRI endpoint was the number of active lesions per patient per scan at 24 weeks.
After 24 weeks, 74.9% (254/339) of patients receiving IFNbeta-1a 44 micro g tiw remained relapse free compared with 63.3% (214/338) of those given 30 micro g qw. The odds ratio for remaining relapse free was 1.9 (95% CI, 1.3 to 2.6; p = 0.0005) at 24 weeks and 1.5 (95% CI, 1.1 to 2.1; p = 0.009) at 48 weeks, favoring 44 micro g tiw. Patients receiving 44 micro g tiw had fewer active MRI lesions (p < 0.001 at 24 and 48 weeks) compared with those receiving 30 micro g qw. Injection-site reactions were more frequent with 44 micro g tiw (83% vs 28%, p < 0.001), as were asymptomatic abnormalities of liver enzymes (18% vs 9%, p = 0.002) and altered leukocyte counts (11% vs 5%, p = 0.003) compared with the 30 micro g qw dosage. Neutralizing antibodies developed in 25% of 44 micro g tiw patients and in 2% of patients receiving 30 micro g qw.
IFNbeta-1a 44 micro g subcutaneously tiw was more effective than IFNbeta-1a 30 micro g IM qw on all primary and secondary outcomes investigated after 24 and 48 weeks of treatment.
干扰素β（IFNβ）可减少复发缓解型多发性硬化症（RRMS）的复发及磁共振成像（MRI）活动，对残疾的影响各不相同。最有效的剂量方案仍存在争议。
这项随机、对照、多中心试验比较了677例RRMS患者皮下注射干扰素β-1a（利比）44μg，每周3次（tiw）与肌肉注射干扰素β-1a（阿沃尼）30μg，每周1次（qw）的疗效和安全性。对治疗不知情的评估者进行神经学和MRI评估。主要终点是24周时无复发患者的比例；主要MRI终点是24周时每次扫描每位患者的活动性病灶数量。
24周后，接受44μg tiw干扰素β-1a治疗的患者中有74.9%（254/339）仍无复发，而接受30μg qw治疗的患者中这一比例为63.3%（214/338）。24周时无复发的优势比为1.9（95%可信区间，1.3至2.6；p = 0.0005），48周时为1.5（95%可信区间，1.1至2.1；p = 0.009），44μg tiw组更具优势。与接受30μg qw治疗的患者相比，接受44μg tiw治疗的患者活动性MRI病灶更少（24周和48周时p < 0.001）。与30μg qw剂量相比，44μg tiw组注射部位反应更频繁（83%对28%，p < 0.001），肝酶无症状异常（18%对9%，p = 0.002）和白细胞计数改变（11%对5%，p = 0.003）的情况也更多。44μg tiw组25%的患者和接受30μg qw治疗的患者中有2%产生了中和抗体。
在治疗24周和48周后，皮下注射44μg tiw的干扰素β-1a在所有研究的主要和次要结局方面比肌肉注射30μg qw的干扰素β-1a更有效。
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