• Media type: E-Article
  • Title: 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
  • Contributor: Hupperts, Raymond; Gasperini, Claudio; Lycke, Jan; Ziemssen, Tjalf; Feys, Peter; Xiao, Shan; Acosta, Carlos; Koster, Thijs; Hobart, Jeremy
  • imprint: SAGE Publications, 2022
  • Published in: Therapeutic Advances in Neurological Disorders
  • Language: English
  • DOI: 10.1177/17562864221090398
  • ISSN: 1756-2864
  • Keywords: Neurology (clinical) ; Neurology ; Pharmacology
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>Background:</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Objective:</jats:title><jats:p> To evaluate the functional benefits and safety of PR-fampridine versus placebo using a post hoc integrated efficacy analysis of MOBILE and ENHANCE data. </jats:p></jats:sec><jats:sec><jats:title>Methods:</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Findings:</jats:title><jats:p> 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 &lt; 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. </jats:p></jats:sec><jats:sec><jats:title>Conclusion:</jats:title><jats:p> 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. </jats:p></jats:sec>
  • Access State: Open Access