Efficacy of prolonged-release fampridine <i>versus</i> placebo on walking ability, dynamic and static balance, physical impact of multiple sclerosis, and quality of life: an integrated analysis of MOBILE and ENHANCE
dc.contributor.author | Hupperts, R | |
dc.contributor.author | Gasperini, C | |
dc.contributor.author | Lycke, J | |
dc.contributor.author | Ziemssen, T | |
dc.contributor.author | Feys, P | |
dc.contributor.author | Xiao, S | |
dc.contributor.author | Acosta, C | |
dc.contributor.author | Koster, T | |
dc.contributor.author | Hobart, J | |
dc.date.accessioned | 2022-06-28T12:11:52Z | |
dc.date.issued | 2022-01-01 | |
dc.identifier.issn | 1756-2856 | |
dc.identifier.issn | 1756-2864 | |
dc.identifier.other | ARTN 17562864221090398 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/19349 | |
dc.description.abstract |
<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 < 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> | |
dc.format.extent | 175628642210903-175628642210903 | |
dc.format.medium | Electronic-eCollection | |
dc.language | en | |
dc.language.iso | eng | |
dc.publisher | SAGE Publications | |
dc.subject | balance | |
dc.subject | fampridine | |
dc.subject | multiple sclerosis | |
dc.subject | quality of life | |
dc.subject | walking | |
dc.title | Efficacy of prolonged-release fampridine <i>versus</i> placebo on walking ability, dynamic and static balance, physical impact of multiple sclerosis, and quality of life: an integrated analysis of MOBILE and ENHANCE | |
dc.type | journal-article | |
dc.type | Journal Article | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000799580800001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.volume | 15 | |
plymouth.publication-status | Published | |
plymouth.journal | Therapeutic Advances in Neurological Disorders | |
dc.identifier.doi | 10.1177/17562864221090398 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2022-03-10 | |
dc.rights.embargodate | 2022-6-29 | |
dc.identifier.eissn | 1756-2864 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1177/17562864221090398 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2022 | |
rioxxterms.type | Journal Article/Review |