Prolonged-release fampridine treatment improved subject-reported impact of multiple sclerosis: Item-level analysis of the MSIS-29

JOURNAL OF THE NEUROLOGICAL SCIENCES

卷:370

Article

Gasperini, Claudio¹  Hupperts, Raymond²  Lycke, Jan³  Short, Christine⁴  McNeill, Manjit⁵  Zhong, John⁶  Mehta, Lahar R.⁶ 

[1] San Camillo Forlanini Hosp, Multiple Sclerosis Ctr, Dept Neurosci, Circonvallazione Gianicolense 87, I-00152 Rome, Italy

[2] Orbis Med Ctr, Sittard Geleen, Netherlands

[3] Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Inst Neurosci & Physiol,Dept Neurosci, Gothenburg, Sweden

[4] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada

[5] Biogen, Maidenhead, Berks, England

[6] Biogen, Cambridge, MA USA

关键词: MSIS-29;    Prolonged-release fampridine;    Multiple sclerosis;    MSWS-12;    Patient-reported outcomes;    Walking impairment;   

DOI  :  10.1016/j.jns.2016.08.052

来源: Elsevier

【 摘 要 】

Prolonged-release (PR) fampridine is approved to treat walking impairment in persons with multiple sclerosis (MS); however, treatment benefits may extend beyond walking. MOBILE was a phase 2, 24-week, double-blind, placebo-controlled exploratory study to assess the impact of 10 mg PR-fampridine twice daily versus placebo on several subject-assessed measures. This analysis evaluated the physical and psychological health outcomes of subjects with progressing or relapsing MS from individual items of the Multiple Sclerosis Impact Scale (MSIS-29). PR-fampridine treatment (n = 68) resulted in greater improvements from baseline in the MSIS-29 physical (PHYS) and psychological (PSYCH) impact subscales, with differences of 89% and 148% in mean score reduction from baseline (n = 64) at week 24 versus placebo, respectively. MSIS-29 item analysis showed that a higher percentage of PR-fampridine subjects had mean improvements in 16/20 PHYS and 6/9 PSYCH items versus placebo after 24 weeks. Post hoc analysis of the 12-item Multiple Sclerosis Walking Scale (MSWS-12) improver population (>= 8-point mean improvement) demonstrated differences in mean reductions from baseline of 97% and 111% in PR-fampridine MSIS-29 PHYS and PSYCH subscales versus the overall placebo group over 24 weeks. A higher percentage of MSWS-12 improvers treated with PR-fampridine showed mean improvements in 20/20 PHYS and 8/9 PSYCH items versus placebo at 24 weeks. In conclusion, PR-fampridine resulted in physical and psychological benefits versus placebo, sustained over 24 weeks. (C) 2016 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

【 授权许可】

Free