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Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate

机译:对复发缓解型多发性硬化症转化为醋酸格拉替雷的患者进行为期2年的观察性COPTIMIZE试验的地域差异分项分析

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Studies suggest that patients with relapsing–remitting multiple sclerosis (RRMS) who fail to benefit from a disease-modifying treatment (DMT) may benefit from converting to another DMT class. COPTIMIZE was a 24-month observational study designed to assess the disease course of patients converting to glatiramer acetate (GA) 20?mg daily from another DMT and the association of disease characteristics and reasons for converting. This sub-analysis was to determine if any findings varied by three geographic locations: Latin America (LA), Canada and Western Europe (CWE), and Eastern Europe (EE). A total of 668 patients were included (263 LA, 248 CWE, 157 EE) in an analysis of annualized relapse rate (ARR) and annualized rate of deterioration (ARD), as well as secondary endpoints including reason for DMT switch and changes in disability and fatigue scores. Repeated-measures analysis of variance and log transformation were used to analyze ARR and ARD, whereas the Wilcoxon signed rank test was used for secondary endpoints. The sub-analysis of treatment outcomes stratified by region showed that Latin American patients had higher ARR before conversion to GA compared with patients from the other two areas and subsequently experienced the largest reduction in ARR. Latin American patients also had higher baseline rates of comorbidities and relapses with incomplete remissions and improved more than those in the other two regions based on measures of fatigue, quality of life, depression, and cognition scores. Latin American patients also generally had a better perception of the benefits associated with their conversion to GA in terms of efficacy and adverse events. These findings indicate that, in RRMS patients, converting to GA is associated with positive treatment outcomes regardless of geographic location. However, the reasons for converting and the type and degree of any associated benefits appear to vary depending on various factors, including patients’ geographical location.
机译:研究表明,患有复发缓解型多发性硬化症(RRMS)的患者未从疾病改良疗法(DMT)中受益,可能会受益于改用另一种DMT。 COPTIMIZE是一项为期24个月的观察性研究,旨在评估每天从另一种DMT转化为醋酸格拉替雷(GA)20 mg的患者的病程以及疾病特征和转化原因之间的关系。该子分析旨在确定是否有任何发现随三个地理位置而异:拉丁美洲(LA),加拿大和西欧(CWE)和东欧(EE)。纳入668例患者(263 LA,248 CWE,157 EE),以分析年复发率(ARR)和年恶化率(ARD),以及次要终点,包括DMT切换原因和残疾变化和疲劳分数。方差和对数变换的重复测量分析用于分析ARR和ARD,而Wilcoxon符号秩检验用于次要终点。对按地区分层的治疗结果进行的亚分析显示,与其他两个地区的患者相比,拉丁美洲患者转换为GA之前的ARR更高,随后经历了最大的ARR降低。根据疲劳,生活质量,抑郁和认知得分的测量,拉丁美洲患者的合并症和复发的基线率也更高,且缓解不完全,并且比其他两个地区的患者改善得更多。从功效和不良事件的角度来看,拉丁美洲患者通常也更好地了解了他们转换为GA的益处。这些发现表明,在RRMS患者中,无论身处何地,转换为GA均与积极的治疗结果相关。但是,转换的原因以及任何相关收益的类型和程度似乎取决于各种因素,包括患者的地​​理位置。

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