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在私人或学术中心接受芬戈莫德治疗的患者中无疾病活动的证据:美国多发性硬化症、临床和磁共振成像结果(MS-MRIUS)研究的回顾性分析。

No evidence of disease activity in patients receiving fingolimod at private or academic centers in clinical practice: a retrospective analysis of the multiple sclerosis, clinical, and magnetic resonance imaging outcomes in the USA (MS-MRIUS) study.

机构信息

a Buffalo Neuroimaging Analysis Center , Buffalo , NY , USA.

b Center for Biomedical Imaging at Clinical Translational Science Institute , Buffalo , NY , USA.

出版信息

Curr Med Res Opin. 2018 Aug;34(8):1431-1440. doi: 10.1080/03007995.2018.1458708. Epub 2018 Apr 12.

DOI:10.1080/03007995.2018.1458708
PMID:29648900
Abstract

OBJECTIVE

The impact of multiple sclerosis (MS) center type on outcomes has not been investigated. This study aimed to evaluate baseline characteristics and clinical and magnetic resonance imaging (MRI) outcomes in patients with MS receiving fingolimod over 16 months' follow-up at private or academic centers in the USA.

METHODS

Clinical and MRI data collected in clinical practice from patients initiating fingolimod were stratified by center type and retrospectively analyzed. No evidence of disease activity (NEDA-3) was defined as patients with no new/enlarged T2/gadolinium-enhancing lesions, no relapses, and no disability progression (Expanded Disability Status Scale scores).

RESULTS

Data were collected for 398 patients from 25 private centers and 192 patients from eight academic centers. Patients were older (median age = 43 vs 41 years; p = .0047) and had a numerically shorter median disease duration (7.0 vs 8.5 years; p = .0985) at private vs academic centers. Annualized relapse rate (ARR) was higher in patients at private than academic centers in the pre-index (0.40 vs 0.29; p = .0127) and post-index (0.16 vs 0.08; p = .0334) periods. The opposite was true for T2 lesion volume in the pre-index (2.86 vs 5.23 mL; p = .0002) and post-index (2.86 vs 5.11 mL; p = .0016) periods; other MRI outcomes were similar between center types. After initiating fingolimod, ARRs were reduced, disability and most MRI outcomes remained stable, and a similar proportion of patients achieved NEDA-3 at private and academic centers (64.1% vs 56.1%; p = .0659).

CONCLUSION

Patient characteristics differ between private and academic centers. Over 55% of patients achieved NEDA-3 during fingolimod treatment at both center types.

摘要

目的

多发性硬化症(MS)中心类型对结果的影响尚未得到研究。本研究旨在评估在美国私人或学术中心接受芬戈莫德治疗 16 个月后的 MS 患者的基线特征以及临床和磁共振成像(MRI)结果。

方法

从启动芬戈莫德治疗的患者的临床实践中收集临床和 MRI 数据,并按中心类型进行分层,然后进行回顾性分析。无疾病活动证据(NEDA-3)定义为无新发/扩大 T2/钆增强病变、无复发和无残疾进展(扩展残疾状况量表评分)的患者。

结果

从 25 个私人中心收集了 398 名患者的数据,从 8 个学术中心收集了 192 名患者的数据。与学术中心相比,私人中心的患者年龄更大(中位数年龄 43 岁 vs 41 岁;p = 0.0047),疾病持续时间更短(中位数 7.0 年 vs 8.5 年;p = 0.0985)。在索引前(0.40 比 0.29;p = 0.0127)和索引后(0.16 比 0.08;p = 0.0334)时期,私人中心的患者年化复发率(ARR)更高。在索引前(2.86 比 5.23 毫升;p = 0.0002)和索引后(2.86 比 5.11 毫升;p = 0.0016)时期,私人中心的 T2 病变体积更小;两种中心类型的其他 MRI 结果相似。启动芬戈莫德治疗后,ARR 降低,残疾和大多数 MRI 结果保持稳定,在私人和学术中心达到 NEDA-3 的患者比例相似(64.1% 比 56.1%;p = 0.0659)。

结论

私人和学术中心之间患者特征存在差异。在两种中心类型中,超过 55%的患者在接受芬戈莫德治疗期间达到了 NEDA-3。

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