How do patients with secondary progressive multiple sclerosis enrolled in the EXPAND randomized controlled trial compare with those seen in German clinical practice in the NeuroTransData multiple sclerosis registry?

IF 2.6 Q2 CLINICAL NEUROLOGY
Journal of Central Nervous System Disease Pub Date : 2022-08-04 eCollection Date: 2022-01-01 DOI:10.1177/11795735221115912
Stefan Braune, Arnfin Bergmann, Vladimir Bezlyak, Nicholas Adlard
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引用次数: 0

Abstract

Background: In EXPAND (NCT01665144), a phase 3 randomized clinical trial, siponimod reduced disability progression versus placebo in patients with secondary progressive multiple sclerosis (SPMS).

Aim: To understand how a real-world population with SPMS relates to that in EXPAND, we conducted a retrospective, observational cohort study using the German NeuroTransData (NTD) multiple sclerosis (MS) registry.

Methods: The NTD MS registry is run by a Germany-wide network of physicians. Two cross-sectional analyses were performed using the NTD MS registry. The first included patients with SPMS, as recorded in the registry, and compared their characteristics between 1 January 2018 and 31 December 2018 with patients in EXPAND. The second described the characteristics of patients in the registry at the time of diagnosis of SPMS between 1 January 2010 and 31 December 2018.

Results: The first analysis included 773 patients: patients were older in the NTD MS registry than in EXPAND (mean age, 57.9 vs 48.0 years) and had a longer duration of SPMS (mean, 6.2 vs 3.8 years). In the NTD MS registry, median Expanded Disability Status Scale (EDSS) scores were comparable to EXPAND (6.0 versus 6.0), although fewer patients had relapses in the previous 24 months (16% vs 36% [siponimod] and 37% [placebo]). Data on gadolinium-enhancing lesions were only available for 5.8% of patients in the NTD MS registry. The second analysis included 916 patients: at the time of SPMS diagnosis, the mean age was 53.2 years and the median EDSS score was 5.0.

Conclusion: The population in the NTD MS registry was older to that in EXPAND, but were similar in terms of disability. Differences likely reflect the inclusion criteria of EXPAND but also highlight that real-world populations encompass a wider range of patient characteristics.

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在EXPAND随机对照试验中登记的继发性进展性多发性硬化症患者与德国临床实践中NeuroTransData多发性硬化症登记处的患者相比如何?
背景:EXPAND (NCT01665144)是一项3期随机临床试验,在继发性进行性多发性硬化症(SPMS)患者中,西ponimod与安慰剂相比可减少残疾进展。目的:为了了解现实世界SPMS人群与EXPAND人群的关系,我们使用德国NeuroTransData (NTD)多发性硬化症(MS)注册中心进行了一项回顾性观察性队列研究。方法:NTD MS注册表由德国范围内的医生网络运行。使用NTD MS注册表进行了两次横断面分析。第一项研究纳入了登记中记录的SPMS患者,并将其在2018年1月1日至2018年12月31日期间的特征与EXPAND患者进行了比较。第二份报告描述了2010年1月1日至2018年12月31日期间诊断为SPMS时登记的患者的特征。结果:第一次分析包括773例患者:NTD MS登记的患者比EXPAND登记的患者年龄大(平均年龄57.9岁对48.0岁),SPMS持续时间更长(平均6.2年对3.8年)。在NTD MS注册中,扩展残疾状态量表(EDSS)的中位数得分与EXPAND相当(6.0比6.0),尽管在过去24个月内复发的患者较少(16%比36%[西ponimod]和37%[安慰剂])。在NTD MS登记中,只有5.8%的患者有钆增强病变的数据。第二次分析纳入916例患者:在SPMS诊断时,平均年龄为53.2岁,中位EDSS评分为5.0。结论:NTD MS登记的人群比EXPAND登记的人群年龄大,但在残疾方面相似。差异可能反映了EXPAND的纳入标准,但也强调了现实世界的人群包含了更广泛的患者特征。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.90
自引率
0.00%
发文量
39
审稿时长
8 weeks
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