Contributions
Abstract: P630
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Introduction: MOBILE, an exploratory study, evaluated prolonged-release fampridine (PR-FAM) 10mg twice daily (n=68) vs placebo (n=64) on self-reported walking and balance in people with multiple sclerosis (PwMS; Expanded Disability Status Scale score 4-7) over 24 weeks. MOBILE identified an 8-point change in the 12-item MS Walking Scale (MSWS-12) as clinically meaningful. ENHANCE was similarly designed (PR-FAM [n=315] vs placebo [n=318]) and used MOBILE's threshold to evaluate clinically meaningful responses in self-reported walking, mobility, balance, and changes in self-reported physical MS impact.
Objectives: A post hoc integrated efficacy analysis of PR-FAM vs placebo using MOBILE and ENHANCE data.
Methods: MOBILE and ENHANCE data were pooled. The main analysis was the proportion of PwMS with a mean improvement in MSWS-12 score exceeding a predetermined threshold (≥8-points) from Baseline (BL) over 24 weeks. Additional endpoints were: Timed Up and Go (TUG) speed, MS Impact Scale physical subscale (MSIS-29 PHYS), Berg Balance Scale (BBS), EuroQol 5-dimensions (EQ-5D) visual analogue scale (VAS) and utility index score (UIS).
Results: 383 PwMS received PR-FAM and 382 PwMS received placebo. Significantly more PR-FAM-treated PwMS achieved a clinically meaningful ≥8 point mean improvement in the MSWS-12 over 24 weeks vs placebo (44.3% vs 33.0%; OR: 1.68 [95%CI: 1.23, 2.29]; P< 0.001). Significantly more PR-FAM PwMS achieved a ≥15% mean improvement from BL on TUG speed (44.1% vs 34.5%; OR: 1.54 [95%CI: 1.13, 2.11]; P=0.007). PR-FAM PwMS had greater mean improvements from BL in the 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. PR-FAM demonstrated benefits on EQ-5D VAS and UIS, albeit not significant.
Conclusions: This post hoc pooled analysis supports previous studies, strengthening evidence that PR-FAM produces clinically meaningful improvements in self-reported walking and benefits self-reported physical function, mobility, balance and quality of life, sustained over 24 weeks.
Disclosure: Supported by: Biogen (Cambridge, MA, USA). Writing and editorial support for the preparation of this abstract was provided by Excel Scientific Solutions (Southport, CT, USA): funding was provided by Biogen.
R. Hupperts has received honoraria and research grants from and advisor boards for Biogen, Merck and Sanofi-Genzyme.
J. Hobart has received consulting/advisor fees, honoraria and research support from Acorda, Biogen, Brickell Biotec, Genzyme, Global Blood Therapeutics, LORA group, Merck Serono, Novartis, Oxford Pharmogenesis, Roche, Tigercat and Vanita.
C. Gasperini has received consulting fees from Bayer HealthCare and Biogen; speaker fees from Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis and Teva.
J. Lycke has received consulting/speaker fees from and is on advisory boards for Biogen, Genzyme, Novartis, Merck, Sanofi-Aventis and Teva; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva.
T. Ziemssen has served on advisory boards, trial steering committees and data and safety monitoring committees for and has received speaker fees and project support from Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
P. Feys has served on advisory boards for Biogen and Novartis; has received speaker fees from Excemed and Teva.
M. McNeill, C. Acosta, and M. Meergans are employees of and hold stock/stock options in Biogen.
Abstract: P630
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Introduction: MOBILE, an exploratory study, evaluated prolonged-release fampridine (PR-FAM) 10mg twice daily (n=68) vs placebo (n=64) on self-reported walking and balance in people with multiple sclerosis (PwMS; Expanded Disability Status Scale score 4-7) over 24 weeks. MOBILE identified an 8-point change in the 12-item MS Walking Scale (MSWS-12) as clinically meaningful. ENHANCE was similarly designed (PR-FAM [n=315] vs placebo [n=318]) and used MOBILE's threshold to evaluate clinically meaningful responses in self-reported walking, mobility, balance, and changes in self-reported physical MS impact.
Objectives: A post hoc integrated efficacy analysis of PR-FAM vs placebo using MOBILE and ENHANCE data.
Methods: MOBILE and ENHANCE data were pooled. The main analysis was the proportion of PwMS with a mean improvement in MSWS-12 score exceeding a predetermined threshold (≥8-points) from Baseline (BL) over 24 weeks. Additional endpoints were: Timed Up and Go (TUG) speed, MS Impact Scale physical subscale (MSIS-29 PHYS), Berg Balance Scale (BBS), EuroQol 5-dimensions (EQ-5D) visual analogue scale (VAS) and utility index score (UIS).
Results: 383 PwMS received PR-FAM and 382 PwMS received placebo. Significantly more PR-FAM-treated PwMS achieved a clinically meaningful ≥8 point mean improvement in the MSWS-12 over 24 weeks vs placebo (44.3% vs 33.0%; OR: 1.68 [95%CI: 1.23, 2.29]; P< 0.001). Significantly more PR-FAM PwMS achieved a ≥15% mean improvement from BL on TUG speed (44.1% vs 34.5%; OR: 1.54 [95%CI: 1.13, 2.11]; P=0.007). PR-FAM PwMS had greater mean improvements from BL in the 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. PR-FAM demonstrated benefits on EQ-5D VAS and UIS, albeit not significant.
Conclusions: This post hoc pooled analysis supports previous studies, strengthening evidence that PR-FAM produces clinically meaningful improvements in self-reported walking and benefits self-reported physical function, mobility, balance and quality of life, sustained over 24 weeks.
Disclosure: Supported by: Biogen (Cambridge, MA, USA). Writing and editorial support for the preparation of this abstract was provided by Excel Scientific Solutions (Southport, CT, USA): funding was provided by Biogen.
R. Hupperts has received honoraria and research grants from and advisor boards for Biogen, Merck and Sanofi-Genzyme.
J. Hobart has received consulting/advisor fees, honoraria and research support from Acorda, Biogen, Brickell Biotec, Genzyme, Global Blood Therapeutics, LORA group, Merck Serono, Novartis, Oxford Pharmogenesis, Roche, Tigercat and Vanita.
C. Gasperini has received consulting fees from Bayer HealthCare and Biogen; speaker fees from Bayer HealthCare, Biogen, Genzyme, Merck Serono, Novartis and Teva.
J. Lycke has received consulting/speaker fees from and is on advisory boards for Biogen, Genzyme, Novartis, Merck, Sanofi-Aventis and Teva; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva.
T. Ziemssen has served on advisory boards, trial steering committees and data and safety monitoring committees for and has received speaker fees and project support from Bayer HealthCare, Biogen, Elan, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Synthon and Teva.
P. Feys has served on advisory boards for Biogen and Novartis; has received speaker fees from Excemed and Teva.
M. McNeill, C. Acosta, and M. Meergans are employees of and hold stock/stock options in Biogen.