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Abstract：
Multiple sclerosis (MS) treatment intervention with immunomodulating therapy at early disease stage improves short term clinical outcomes. The objective of this study is to describe the long-term outcomes and healthcare utilization of patients with clinically isolated syndrome (CIS) included in the Betaferon®/Betaseron® in Newly Emerging MS for Initial Treatment (BENEFIT) randomized, parallel group trial. In BENEFIT patients were assigned to \"early\" IFNB-1b treatment or placebo (\"delayed\" treatment). After 2 years or conversion to clinically definite multiple sclerosis (CDMS), all patients were offered IFNB-1b and were reassessed 15 years later. Of 468 patients, 261 (55.8%) were enrolled into BENEFIT 15 (161 [55.1%] from the early, 100 [56.8%] from the delayed treatment arm). In the full BENEFIT analysis set, risk of conversion to CDMS remained lower in the early treatment group ( - 30.5%; hazard ratio 0.695 [95% CI, 0.547-0.883]; p = 0.0029) with a 15.7% lower risk of relapse than in the delayed treatment group (p = 0.1008). Overall, 25 patients (9.6%; 9.9% early, 9.0% delayed) converted to secondary progressive multiple sclerosis. Disability remained low and stable with no significant difference between groups in Expanded Disability Status Scale score or MRI metrics. Paced Auditory Serial Addition Task-3 scores were better in the early treatment group (p = 0.0036 for treatment effect over 15 years). 66.3% of patients were still employed at Year 15 versus 74.7% at baseline. In conclusion, results 15 years from initial randomization support long-term benefits of early treatment with IFNB-1b.
摘要：
多发性硬化症（MS）治疗干预与免疫调节治疗在疾病早期阶段改善短期临床结果。本研究的目的是描述Betaferon®/Betaseron®在新兴MS初始治疗（BENEFIT）中随机分组的临床孤立综合征（CIS）患者的长期结果和医疗保健利用，平行组试验。在BENEFIT中，患者被分配到“早期”IFNB-1b治疗或安慰剂（“延迟”治疗）。2年后或转换为临床明确的多发性硬化症（CDMS），所有患者均接受IFNB-1b治疗,并在15年后重新评估.468名患者中,261人（55.8%）被纳入受益15人（161人[55.1%]，100[56.8%]来自延迟治疗组)。在完整的利益分析集中，早期治疗组患者转CDMS的风险仍然较低(-30.5%;风险比0.695[95%CI,0.547-0.883];p=0.0029),复发风险比延迟治疗组低15.7%(p=0.1008).总的来说,25例患者（9.6％；早期9.9％，9.0％延迟）转化为继发性进行性多发性硬化症。在扩展的残疾状态量表评分或MRI指标中，残疾率保持较低且稳定，组间没有显着差异。在早期治疗组中，起搏听觉系列增加任务-3评分更好（对于15年以上的治疗效果，p=0.0036）。66.3%的患者在15年仍有工作，而基线为74.7%。总之,从初始随机化开始的15年结果支持IFNB-1b早期治疗的长期益处.
