Efficacy of prolonged-release fampridine versus placebo on walking ability, dynamic and static balance, physical impact of multiple sclerosis, and quality of life: an integrated analysis of MOBILE and ENHANCE

被引：2

作者：

Hupperts, Raymond ^{[1
]}

Gasperini, Claudio ^{[2
]}

Lycke, Jan ^{[3
,4
]}

Ziemssen, Tjalf ^{[5
]}

Feys, Peter ^{[6
,7
]}

Xiao, Shan ^{[8
]}

Acosta, Carlos ^{[9
]}

Koster, Thijs ^{[8
]}

Hobart, Jeremy ^{[10
]}

机构：

[1] Zuyderland Med Ctr, Dept Neurol, NL-6130 MB Sittard, Netherlands

[2] S Camillo Forlanini Hosp, Dept Neurosci, Rome, Italy

[3] Sahlgrens Acad, Inst Neurosci & Physiol, Dept Clin Neurosci, Gothenburg, Sweden

[4] Sahlgrens Univ Hosp, Dept Neurol, Gothenburg, Sweden

[5] Tech Univ Dresden, Ctr Clin Neurosci, Carl Gustav Carus Univ Clin, Dresden, Germany

[6] Hasselt Univ, Fac Rehabil Sci, REVAL, Diepenbeek, Belgium

[7] UMSC Hasselt, Pelt, Belgium

[8] Biogen, Cambridge, MA USA

[9] Biogen, Baar, Switzerland

[10] Univ Plymouth, Peninsula Sch Med & Dent, Plymouth Hosp NHS Trust, Plymouth, Devon, England

来源：

THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS | 2022年 / 15卷

关键词：

balance; fampridine; multiple sclerosis; quality of life; walking; DIAGNOSTIC-CRITERIA; SCALE; IMPAIRMENT; EXERCISE; FATIGUE; GAIT; MS; DALFAMPRIDINE; DISORDERS; THERAPY;

D O I：

10.1177/17562864221090398

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background: MOBILE and ENHANCE were similarly designed randomized trials of walking-impaired adults with relapsing-remitting or progressive multiple sclerosis (MS) who received placebo or 10 mg prolonged-release (PR)-fampridine twice daily for 24 weeks. Both studies showed sustained and clinically meaningful improvement in broad measures of walking and balance over 24 weeks of PR-fampridine treatment. Objective: To evaluate the functional benefits and safety of PR-fampridine versus placebo using a post hoc integrated efficacy analysis of MOBILE and ENHANCE data. Methods: Data from the intention-to-treat (ITT) populations of MOBILE and ENHANCE studies were pooled in a post hoc analysis based on the following outcome measures: 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) speed, Berg Balance Scale (BBS), MS Impact Scale physical impact subscale (MSIS-29 PHYS), EQ-5D utility index score, visual analogue scale (VAS), and adverse events. The primary analysis was the proportion of people with MS (PwMS) with a mean improvement in MSWS-12 score (> 8 points) from baseline over 24 weeks. A subgroup analysis based on baseline characteristics was performed. Findings: In the ITT population (N = 765; PR-fampridine, n = 383; placebo, n = 382), a greater proportion of PR-fampridine-treated PwMS than placebo-treated PwMS achieved a clinically meaningful improvement in the MSWS-12 scale over 24 weeks (44.3% versus 33.0%; p < 0.001). PR-fampridine MSWS-12 responders demonstrated greater improvements from baseline in TUG speed, BBS score, MSIS-29 PHYS score, and EQ-5D utility index and VAS scores versus PR-fampridine MSWS-12 nonresponders and placebo. Subgroup analyses based on baseline characteristics showed consistency in the effects of PR-fampridine. Conclusion: The pooled analysis of MOBILE and ENHANCE confirms previous evidence that treatment with PR-fampridine results in clinically meaningful improvements in walking, mobility and balance, self-reported physical impact of MS, and quality of life and is effective across a broad range of PwMS.

引用

页数：23