Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT
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DOI：
10.1136/jnnp-2013-306222
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发表时间：
2014-11-01
影响因子：
11
通讯作者：
Pleimes, D.
中科院分区：
文献类型：
--
作者：
Edan, G.;Kappos, L.;Pleimes, D.
目的探讨早期开始使用干扰素β -1b （IFNB1b, Betaferon/Betaseron）治疗多发性硬化症（MS）患者的长期影响。方法：在BENEFIT的初始安慰剂对照期，患者被随机分配到每隔一天皮下注射250 μ g IFNB1b或安慰剂。在2年或诊断为临床明确的MS （CDMS）后，所有患者接受开放标签IFNB1b治疗，最长持续时间为5年。此后，患者被纳入一项长达8.7年的观察性扩展研究。在最初的468例患者中，284例（60.7%；IFNB1b: 178例（原始组的61.0%），安慰剂：106例（原始组的60.2%））被纳入扩展研究。94.2%的患者接受IFNB1b治疗。最初随机分配到IFNB1b的患者在8年的观察期内发生CDMS的风险降低了32.2% (HR 0.678; 95% CI 0.525至0.875;p=0.0030)，发生CDMS的中位时间延长了1345天（95% CI 389至2301），年化复发率较低（0.196 （95% CI 0.176至0.218）对0.255 (95% CI 0.226至0.287),p= 0.0012），差异主要出现在研究的第一年。早期治疗患者的认知结果仍然较高。随着时间的推移，EDSS仍然很低，两组的中位数为1.5。结论：这8年的研究结果进一步支持IFNB1b在首发事件提示多发性硬化的患者中早期开始治疗。
Objective To examine the long-term impact of early treatment initiation of interferon beta-1b (IFNB1b, Betaferon/Betaseron) in patients with a first event suggestive of multiple sclerosis (MS).Methods In the original placebo-controlled phase of BENEFIT, patients were randomised to IFNB1b 250 mu g or placebo subcutaneously every other day. After 2 years or diagnosis of clinically definite MS (CDMS), all patients were offered open-label IFNB1b treatment for a maximum duration of 5 years. Thereafter, patients were enrolled in an observational extension study for up to 8.7 years.Results Of the initial 468 patients, 284 (60.7%; IFNB1b: 178 (61.0% of the original arm), placebo: 106 (60.2% of original arm)) were enrolled in the extension study. 94.2% of patients were receiving IFNB1b. Patients originally randomised to IFNB1b had a reduced risk of developing CDMS by 32.2% over the 8-year observation period (HR 0.678; 95% CI 0.525 to 0.875; p=0.0030), a longer median time to CDMS by 1345 days (95% CI 389 to 2301), and a lower annualised relapse rate (0.196 (95% CI 0.176 to 0.218) versus 0.255 (95% CI 0.226 to 0.287), p= 0.0012), with differences mainly emerging in the first year of the study. Cognitive outcomes remained higher in the early treated patients. EDSS remained low over time with a median of 1.5 in both arms.Conclusions These 8-year results provide further evidence supporting early initiation of treatment with IFNB1b in patients with a first event suggestive of MS.