Faculty of Medicine, Division of Neurology, University of British Columbia, Vancouver, BC, Canada.
Mult Scler. 2012 Oct;18(10):1412-21. doi: 10.1177/1352458512439119. Epub 2012 Jun 26.
Improvements in multiple sclerosis (MS) disability have recently been reported in immunomodulatory drug (IMD) clinical trials and observational studies. However, improvements have rarely been examined in natural history or IMD naive patients. We investigated annual and biennial improvements in Expanded Disability Status Scale (EDSS) scores in British Columbia, Canada.
The British Columbian MS database was accessed for definite MS patients (1980-2009). Consecutive IMD-free EDSS scores one and two years apart (± 3 months) were examined; improvements (≥0.5,≥1,≥2 EDSS points) and sustained improvements (confirmed at one year) were described. The influence of patient characteristics on improvements was examined using logistic regression.
From 16,132 EDSS scores, 7653 yearly and 5845 biennial EDSS intervals were available for 2961 and 2382 patients respectively. Of the yearly intervals, 14.9% showed an improvement (≥0.5 points), 8.3% ≥1 point and 2.2% ≥2 point improvement, with nearly half being sustained. Corresponding worsenings were observed in 32.9%, 20.5% and 7.9% respectively, with stability in just over half (53%). Biennial findings were similar. Characteristics generally associated with improvements included: female sex, younger age, shorter disease duration, relapsing-onset and presence of moderate disability (compared with mild or advanced) and a previous episode of worsening (disassociated from a relapse). However, improvements were also observed after periods of stability and in primary-progressive MS.
Improvements in MS disability over one or two years are not unusual. We suggest the term 'innate improvements'. Our findings have implication for the design of clinical trials and observational studies in MS targeting improvements on the EDSS.
最近在免疫调节药物（IMD）临床试验和观察性研究中报告了多发性硬化症（MS）残疾的改善。然而，在自然史或 IMD 初治患者中很少检查到改善。我们研究了加拿大不列颠哥伦比亚省的扩展残疾状况量表（EDSS）评分的年度和两年改善。
访问了不列颠哥伦比亚省的 MS 数据库，以获取明确的 MS 患者（1980-2009 年）。检查了相隔一年和两年的连续 IMD 免费 EDSS 评分（±3 个月）；描述了改善（≥0.5、≥1、≥2 EDSS 点）和持续改善（在一年时得到证实）。使用逻辑回归检查了患者特征对改善的影响。
从 16132 个 EDSS 评分中，有 7653 个每年和 5845 个每两年的 EDSS 间隔可用于 2961 和 2382 名患者。在每年的间隔中，有 14.9%的患者出现改善（≥0.5 点），8.3%的患者改善≥1 点，2.2%的患者改善≥2 点，近一半的患者得到了持续改善。相应的恶化分别为 32.9%、20.5%和 7.9%，只有一半以上（53%）稳定。两年期的结果相似。通常与改善相关的特征包括：女性、年龄较小、疾病持续时间较短、复发发作和存在中度残疾（与轻度或晚期相比）以及先前的恶化发作（与复发无关）。然而，在稳定期和原发性进展性 MS 中也观察到了改善。
在一到两年内，MS 残疾的改善并不罕见。我们建议使用“固有改善”这个术语。我们的发现对临床试验和针对 EDSS 改善的 MS 观察性研究的设计具有启示意义。
