Neurocenter of Southern Switzerland, Ente Ospedaliero Cantonale, Ospedale Regionale di Lugano, Lugano, Switzerland. claudio.gobbi @ eoc.ch
Eur Neurol. 2013;70(1-2):35-41. doi: 10.1159/000346761. Epub 2013 May 14.
There is a scarcity of reports comparing efficacy and tolerability of the multiple sclerosis (MS) disease-modifying therapies [DMTs; intramuscular interferon-β1a (IM IFNβ-1a), subcutaneous (SC) IFNβ-1a, SC IFNβ-1b, SC glatiramer acetate (GA)] in a real-world setting.
This multicenter, non-interventional, retrospective cohort study analyzed data from 546 patients with clinically isolated or relapsing-remitting MS constantly treated with one DMT for 2 years. Annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) scores, and DMT tolerability were assessed.
Demographic data were comparable across DMTs. There were no significant differences between DMT groups in ARR during study year 1 (p = 0.277) or study year 2 (p = 0.670), or in EDSS change between years 1 and 2 (p = 0.624). Adverse events were frequent (39-56%) in all groups. Flu-like symptoms were less frequent with GA treatment (2.3% vs. IM IFNβ-1a, 46.7%; SC IFNβ-1a, 39.8%; SC IFNβ-1b, 25.8%; p < 0.05). Injection site reactions were less often reported with IM IFNβ-1a (10.5% vs. SC IFNβ-1a, 33.9%; SC IFNβ-1b, 38.3%; GA, 26.1%; p < 0.05).
All DMTs showed comparable effects on MS relapse rate and EDSS change, with IM IFNβ-1a and GA being more tolerable with respect to injection site reactions and flu-like symptoms, respectively.
在真实环境中,比较多发性硬化症(MS)疾病修正治疗(DMT;肌肉内干扰素-β1a(IM IFNβ-1a)、皮下(SC)干扰素-β1a、SC 干扰素-β1b、SC 那他珠单抗)疗效和耐受性的报告很少。
这项多中心、非干预性、回顾性队列研究分析了 546 例接受一种 DMT 持续治疗 2 年的临床孤立或复发缓解型 MS 患者的数据。评估了年复发率(ARR)、扩展残疾状况量表(EDSS)评分和 DMT 耐受性。
DMT 之间的人口统计学数据具有可比性。在研究年 1 时(p=0.277)或研究年 2 时(p=0.670)ARR 或 1 年至 2 年之间 EDSS 变化,各 DMT 组之间无显著差异。所有组中不良事件均频繁发生(39-56%)。GA 治疗时流感样症状较少(2.3% vs. IM IFNβ-1a,46.7%;SC IFNβ-1a,39.8%;SC IFNβ-1b,25.8%;p<0.05)。IM IFNβ-1a 报告的注射部位反应较少(10.5% vs. SC IFNβ-1a,33.9%;SC IFNβ-1b,38.3%;GA,26.1%;p<0.05)。
所有 DMT 对 MS 复发率和 EDSS 变化的疗效相当,IM IFNβ-1a 和 GA 在注射部位反应和流感样症状方面的耐受性更好。