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在复发缓解型多发性硬化症患者转换为醋酸格拉替雷的为期两年的观察性COPTIMIZE试验中对地理差异进行亚分析。

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

作者信息

Ziemssen Tjalf, Gilgun-Sherki Yossi

机构信息

Center of Clinical Neuroscience, Neurological University Clinic, University Clinic Carl Gustav Carus, University of Technology Dresden, Fetscherstraße 74, D-01307, Dresden, Germany.

Teva Pharmaceutical Industries Ltd, 5 Basel Street, Petah Tikva, 49131, Israel.

出版信息

BMC Neurol. 2015 Oct 8;15:189. doi: 10.1186/s12883-015-0448-4.

Abstract

BACKGROUND

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).

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

研究表明,复发缓解型多发性硬化症(RRMS)患者若无法从疾病修正治疗(DMT)中获益,转而使用另一类DMT可能会从中受益。COPTIMIZE是一项为期24个月的观察性研究,旨在评估从另一类DMT转换为每日20毫克醋酸格拉替雷(GA)的患者的疾病进程,以及疾病特征与转换原因之间的关联。这项亚分析旨在确定三个地理位置(拉丁美洲(LA)、加拿大和西欧(CWE)以及东欧(EE))的研究结果是否存在差异。

方法

共有668名患者纳入分析(263名来自拉丁美洲、248名来自加拿大和西欧、157名来自东欧),分析年化复发率(ARR)和年化恶化率(ARD),以及次要终点,包括DMT转换原因和残疾及疲劳评分的变化。采用重复测量方差分析和对数转换分析ARR和ARD,而次要终点则采用Wilcoxon符号秩检验。

结果

按地区分层的治疗结果亚分析显示,与其他两个地区的患者相比,拉丁美洲患者在转换为GA之前的ARR更高,随后ARR下降幅度最大。拉丁美洲患者的合并症和复发基线率也更高,缓解不完全,并且在疲劳、生活质量、抑郁和认知评分方面的改善程度超过其他两个地区。拉丁美洲患者对转换为GA在疗效和不良事件方面的益处也普遍有更好的认知。

结论

这些发现表明,在RRMS患者中,无论地理位置如何,转换为GA都与积极的治疗结果相关。然而,转换的原因以及任何相关益处的类型和程度似乎因各种因素而异,包括患者的地理位置。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20d7/4599648/e141eaaab58f/12883_2015_448_Fig1_HTML.jpg

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