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191 MOBILE/ENHANCE integrated efficacy analysis of PR-fampridine
  1. Raymond Hupperts1,
  2. Jeremy Hobart2,
  3. Claudio Gasperini3,
  4. Jan Lycke4,
  5. Tjalf Ziemssen5,
  6. Peter Feys6,
  7. Manjit McNeill7,
  8. Carlos Acosta8
  1. 1Zuyderland Medical Center, Sittard, The Netherlands
  2. 2Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK
  3. 3Department of Neurosciences, S. Camillo Forlanini Hospital, Roma, Italy
  4. 4Institute of Neuroscience and Physiology, The Sahlgrenska Academy, Göteborg, Sweden
  5. 5Center of Clinical Neuroscience, Technical University of Dresden, Dresden, Germany
  6. 6BIOMED/REVAL, Hasselt University, Diepenbeek, Belgium
  7. 7Biogen, Maidenhead, UK
  8. 8Biogen, Baar, Switzerland


Introduction The MOBILE and ENHANCE studies evaluated prolonged-release fampridine (PR-FAM) vs placebo (MOBILE, n=68 vs 64; ENHANCE, n=315 vs 318) in people with multiple sclerosis (PwMS) over 24 weeks. PR-FAM-associated improvements in walking and physical performance were assessed using an integrated efficacy analysis.

Methods Pooled analyses of MOBILE/ENHANCE included the proportion of PR-FAM–treated PwMS with pre-specified threshold improvement in MSWS-12 and in Timed Up and Go (TUG) speed, and mean changes from baseline in MS Impact Scale physical subscale (MSIS-29 PHYS) and Berg Balance Scale (BBS).

Results Over 24 weeks, significantly more PR-FAM–treated PwMS achieved ≥8-point mean improvement in MSWS-12 (44.3% vs 33.0%; OR: 1.68 [95%CI: 1.23, 2.29]; P<0.001) and ≥15% mean improvement in TUG speed (44.1% vs 34.5%; OR: 1.54 [95%CI: 1.13, 2.11]; P=0.007) vs placebo. Significant improvements from baseline were also registered in MSIS-29 PHYS (least square mean [LSM] difference: −3.18 [95%CI: −4.84, −1.52]; P<0.001) and BBS (LSM difference: 0.62 [95%CI: 0.09, 1.14]; P=0.021) vs placebo.

Conclusions This post-hoc pooled analysis strengthens evidence that PR-FAM produces clinically meaningful improvements in self-reported walking and benefits self-reported physical function, mobility, balance, and quality of life over 24 weeks for PwMS.

Support: Biogen. Disclosures to be included on poster.

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