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

Raymond Hupperts; Claudio Gasperini; Jan Lycke; Tjalf Ziemssen; Peter Feys; Shan Xiao; Carlos Acosta; Thijs Koster; Jeremy Hobart

doi:10.1177/17562864221090398

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

Ther Adv Neurol Disord. 2022 May 18:15:17562864221090398. doi: 10.1177/17562864221090398. eCollection 2022.

Authors

Raymond Hupperts¹, Claudio Gasperini², Jan Lycke³, Tjalf Ziemssen⁴, Peter Feys⁵, Shan Xiao⁶, Carlos Acosta⁷, Thijs Koster⁶, Jeremy Hobart⁸

Affiliations

¹ Department of Neurology, Zuyderland Medical Center, 6130 MB Sittard, The Netherlands.
² Department of Neurosciences, S. Camillo Forlanini Hospital, Rome, Italy.
³ Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy and Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden.
⁴ Center of Clinical Neuroscience, Carl Gustav Carus University Clinic, Technical University of Dresden, Dresden, Germany.
⁵ REVAL, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium; UMSC Hasselt, Pelt, Belgium.
⁶ Biogen, Cambridge, MA, USA.
⁷ Biogen, Baar, Switzerland.
⁸ Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth Hospitals NHS Trust, Plymouth, UK.

Abstract

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.

Keywords: balance; fampridine; multiple sclerosis; quality of life; walking.