Department of Neurology, Royal Melbourne Hospital, Victoria, Australia.
PLoS One. 2012;7(6):e38661. doi: 10.1371/journal.pone.0038661. Epub 2012 Jun 29.
We conducted a prospective study, MSBASIS, to assess factors leading to first treatment discontinuation in patients with a clinically isolated syndrome (CIS) and early relapsing-remitting multiple sclerosis (RRMS).
The MSBASIS Study, conducted by MSBase Study Group members, enrols patients seen from CIS onset, reporting baseline demographics, cerebral magnetic resonance imaging (MRI) features and Expanded Disability Status Scale (EDSS) scores. Follow-up visits report relapses, EDSS scores, and the start and end dates of MS-specific therapies. We performed a multivariable survival analysis to determine factors within this dataset that predict first treatment discontinuation.
A total of 2314 CIS patients from 44 centres were followed for a median of 2.7 years, during which time 1247 commenced immunomodulatory drug (IMD) treatment. Ninety percent initiated IMD after a diagnosis of MS was confirmed, and 10% while still in CIS status. Over 40% of these patients stopped their first IMD during the observation period. Females were more likely to cease medication than males (HR 1.36, p = 0.003). Patients treated in Australia were twice as likely to cease their first IMD than patients treated in Spain (HR 1.98, p = 0.001). Increasing EDSS was associated with higher rate of IMD cessation (HR 1.21 per EDSS unit, p<0.001), and intramuscular interferon-β-1a (HR 1.38, p = 0.028) and subcutaneous interferon-β-1a (HR 1.45, p = 0.012) had higher rates of discontinuation than glatiramer acetate, although this varied widely in different countries. Onset cerebral MRI features, age, time to treatment initiation or relapse on treatment were not associated with IMD cessation.
In this multivariable survival analysis, female sex, country of residence, EDSS change and IMD choice independently predicted time to first IMD cessation.
我们开展了一项前瞻性研究（MSBASIS），以评估临床孤立综合征（CIS）和早期复发缓解型多发性硬化症（RRMS）患者首次治疗中断的相关因素。
MSBASIS 研究由 MSBase 研究小组开展，纳入了从 CIS 发病开始就诊的患者，报告了基线人口统计学、脑磁共振成像（MRI）特征和扩展残疾状态量表（EDSS）评分。随访时报告复发、EDSS 评分以及 MS 特异性治疗的开始和结束日期。我们进行了多变量生存分析，以确定该数据集中预测首次治疗中断的因素。
来自 44 个中心的 2314 例 CIS 患者中位随访 2.7 年，期间 1247 例患者开始接受免疫调节药物（IMD）治疗。90%的患者在确诊 MS 后开始 IMD 治疗，10%的患者仍处于 CIS 状态。在观察期间，超过 40%的患者停止了他们的首次 IMD 治疗。女性停止用药的可能性高于男性（HR 1.36，p=0.003）。与在西班牙治疗的患者相比，在澳大利亚治疗的患者停止首次 IMD 的可能性是其两倍（HR 1.98，p=0.001）。EDSS 升高与 IMD 停药率升高相关（每增加 1 个 EDSS 单位，HR 1.21，p<0.001），与干扰素-β-1a 肌内注射（HR 1.38，p=0.028）和干扰素-β-1a 皮下注射（HR 1.45，p=0.012）相比，更易导致醋酸格拉替雷停药，但不同国家之间差异很大。脑 MRI 发病特征、年龄、治疗开始时间或治疗期间复发与 IMD 停药无关。
在这项多变量生存分析中，女性、居住国家、EDSS 变化和 IMD 选择独立预测首次 IMD 停药时间。
