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Long-term prolonged-release fampridine treatment and health-related quality of life outcomes: 12-month analysis of the ENABLE study
ECTRIMS Online Library. Macdonell R. Oct 3, 2013; 34145
Disclosure(s): This study is funded by Biogen Idec. Alison Gagnon of Excel Scientific Solutions provided medical writing and editorial support to the authors in the development of this poster, which was funded by Biogen Idec. Richard Macdonell has served on scientific advisory boards for Biogen Idec, Merck Serono, Novartis, and Sanofi-Genzyme and has received speaker honoraria from Biogen Idec, Merck Serono, Bayer Schering, and Sanofi-Genzyme. Per Soelberg Sorensen served on scientific advisory boards of Biogen Idec, Merck Serono, Novartis, Genmab, TEVA, Elan, and GlaxoSmithKline and has been on steering committees or independent data monitoring boards in clinical trials sponsored by Merck Serono, Genmab, TEVA, GlaxoSmithKline, and Bayer Schering, for which he has received funding of travel for these activities. He has received speaker honoraria from Biogen Idec, Merck Serono, TEVA, Bayer Schering, sanofi-aventis, and Novartis. The Department of Neurology, Rigshospitalet has received research support from Biogen Idec, Bayer Schering, Merck Serono, TEVA, Baxter, sanofi-aventis, BioMS, Novartis, Bayer, RoFAR, Roche, and Genzyme. Carlo Pozzilli received personal compensation as speaker in meetings from and as a member of scientific boards for Bayer Schering, sanofi-aventis, Merck Serono, Biogen Idec, and Norvartis and the Department of Neurology and Psychiatry have received research support from Biogen Idec, Merck Serono, Italian MS Society, and Novartis. Guy Nagels received compensation for serving on the international Fampyra advisory board of Biogen and for consulting for Biogen Belux and holds an unrestricted research chair sponsored by Biogen Idec at the Vrije Universiteit. David Laplaud has nothing to declare. Brigit de Jong served on national advisory boards for Biogen Idec and Novartis. Ana Martins Silva received compensation as speaker in meetings and for consulting, clinical trial research, and advisory board participation from Biogen Idec, Novartis, Pfizer, Bayer, Merck-Serono, and sanofi-aventis. Richard Nicholas has consulted for Biogen and Novartis and has traveled on behalf of Merck Serono and Teva. Julia A. Gaebler is a full-time employee of Biogen Idec. Sonalee Agarwal is a full-time employee of Biogen Idec. Ping Wang is a full-time employee of Biogen Idec.
Dr. Richard Macdonell
Dr. Richard Macdonell
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Abstract
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Background: Walking impairment negatively impacts health-related quality of life (HRQoL) in multiple sclerosis (MS). Prolonged-release (PR) fampridine tablets (dalfampridine extended release tablets in the US) have been shown to improve walking in patients with MS.
Methods: ENABLE is an ongoing open-label, 48-week, multicenter, observational study to evaluate the effects of PR-fampridine 10 mg twice daily on HRQoL in MS patients with clinician-assessed walking impairment. Patients completed the Timed 25-Foot Walk (T25FW) at baseline and Weeks 2 and 4 and the MS Walking Scale (MSWS-12) at baseline and Week 4. Patients who showed any improvement in T25FW speed at both Weeks 2 and 4 and any improvement in MSWS-12 score at Week 4 remained on treatment. HRQoL measures include the SF-36, EQ-5D, MS Impact Scale (MSIS-29), and the Patient Reported Indices for MS (PRIMUS) Activity Limitations Scale, and are assessed at baseline, Weeks 12, 24, 36, and 48. The primary endpoint is the change from baseline in the SF-36 physical component summary (PCS) score at Weeks 12, 24, 36, and 48 in patients on treatment.
Results: 901 patients were enrolled in ENABLE with mean (median) EDSS of 5.2 (6.0), mean time since diagnosis of 12.1 years, and 61% had progressive MS. At baseline, mean (SD) walking speed was 2.52 (1.29) ft/sec, MSWS-12 was 70.5 (22.1), and SF-36-PCS was 33.7 (8.0). At Week 4, 704/901 (78.1%) patients met the criteria to remain on treatment. Interim data demonstrate improvement in SF-36 PCS scores from baseline with mean (95% CI) change at Week 12 (n=659): 4.63 (4.13, 5.14; P<0.0001); Week 24 (n=615): 4.13 (3.58, 4.69; P<0.0001); and Week 36 (n=575): 3.86 (3.30, 4.42; P<0.0001) in patients on treatment. MSIS-29 Physical scores at Week 12 also showed improvement from baseline with mean (95% CI) change at Week 12 (n=672): -12.99 (-14.24, -11.74; P<0.0001); Week 24 (n=634): -10.84 (-12.22, -9.46; P<0.0001); and Week 36 (n=584): -9.50 (-10.97, -8.04; P<0.0001) in patients on treatment. Similar interim results were observed for the EQ-5D and PRIMUS Activity Limitations Scale.
Conclusions: PR-fampridine treatment, which improves walking in MS, is associated with benefits on HRQoL as early as 12 weeks that continue through 9 months of treatment.
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