title: Prolonged-release fampridine treatment improved subject-reported impact of multiple sclerosis: Item-level analysis of the MSIS-29.
abstract: 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 10mg 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 24weeks. 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 24weeks. 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 24weeks. In conclusion, PR-fampridine resulted in physical and psychological benefits versus placebo, sustained over 24weeks.
authors: Multiple Sclerosis Center, Department of Neurosciences, San Camillo-Forlanini Hospital, Rome, Italy. Electronic address: c.gasperini@libero.it.
authors: Claudio
authors: C
authors: Gasperini
authors: Orbis Medical Center, Sittard-Geleen, The Netherlands.
authors: Raymond
authors: R
authors: Hupperts
authors: Institute of Neuroscience and Physiology, Department of Neuroscience, The Sahlgrenska Academy, University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors: Jan
authors: J
authors: Lycke
authors: Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia Canada.
authors: Christine
authors: C
authors: Short
authors: Biogen, Maidenhead, UK.
authors: Manjit
authors: M
authors: McNeill
authors: Biogen, Cambridge, MA, USA.
authors: John
authors: J
authors: Zhong
authors: Biogen, Cambridge, MA, USA.
authors: Lahar R
authors: LR
authors: Mehta
mesh_terms: D015761:4-Aminopyridine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D026902:Potassium Channel Blockers / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D026902:Potassium Channel Blockers; D015761:4-Aminopyridine
keywords: MSIS-29; MSWS-12; Multiple sclerosis; Patient-reported outcomes; Prolonged-release fampridine; Walking impairment