Abstract Details

Title Change in Quality of Life Outcomes with Prolonged-Release Fampridine Treatment: Interim Analysis of the ENABLE Study

Topic MS and Related Diseases

Presentation(s) P03 - (-)

Poster/Presentation
Number 218

Objective

Background BACKGROUND: Walking impairment is a disability marker in MS. Deterioration of walking speed (WS) on the Timed 25-Foot Walk (T25FW) has been associated with diminished HRQoL. PR-fampridine is associated with consistent improvements in WS versus placebo; however, no prospectively-collected HRQoL data exist among MS patients treated with PR-fampridine.

Design/Methods DESIGN/METHODS: ENABLE is an open-label, 48-week, multicenter, multinational, observational study to assess the effects of PR-fampridine on HRQoL in MS patients with clinician-judged walking impairment able to complete the T25FW. At baseline, patients completed the T25FW, 12-item MS Walking Scale (MSWS-12), and five HRQoL measures. Patients received PR-fampridine 10mg twice daily. T25FW and MSWS-12 were reassessed at Weeks 2/4 and Week 4, respectively. Patients demonstrating clinical benefit (primary endpoint: faster WS at Weeks 2 and 4 and MSWS-12 improvement at Week 4 versus baseline) were eligible to continue treatment. HRQoL measures were repeated in continuing patients at Weeks 12, 24, 36, and 48.

Results RESULTS: Of the 903 patients enrolled, 621 had baseline data available as of September 17, 2012; 57.7% female; mean (SD) age: 49.3 (9.80) years; EDSS: mean 5.2, median 5.75; mean (SD) years since diagnosis: 12.2 (7.83); 60.4% had progressive forms of MS. At baseline, mean (SD) WS, MSWS-12 and Short Form-36 physical component score (SF36 PCS) were 2.6 (1.26) ft/sec, 70.2 (22.06) and 33.8 (8.05), respectively. Based on Week 4 assessment, 88.7% of patients continued treatment. At Week 12, a subset of continuing patients (n=168) demonstrated improvement in SF-36 PCS scores from baseline (mean change 4.8; P<0.001). Additional interim improvement on other HRQoL measures will be reported.

Conclusions CONCLUSIONS: ENABLE will provide insight into how PR-fampridine-mediated improvements in walking impact HRQoL in MS patients.

Authors/Disclosures
Richard A. Macdonell, MD, FAAN (Austin Health) PRESENTER	Dr. Macdonell has nothing to disclose.
Guy Nagels, MD (National Multiple Sclerose Centrum)	No disclosure on file
Per Solberg Sorensen, MD, PhD, FAAN (Rigshospitalet Glostrup)	Dr. Sorensen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Sorensen has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Sorensen has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Sorensen has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA.
David Laplaud	No disclosure on file
Carlo Pozzilli	Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion.
Ana M. Silva, MD (Gervico De Neurologia)	No disclosure on file
Mitchell S. Elkind, MD, MS, FAAN	Dr. Elkind has received personal compensation for serving as an employee of American Heart Association. Dr. Elkind has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Atria Academy.
Richard S. Nicholas, FRCP (Imperial College Healthcare Trust)	Dr. Nicholas has nothing to disclose.
Mathias J. Niedhammer, MD	No disclosure on file
Julia Gaebler	No disclosure on file
Sonalee Agarwal, PhD (Biogen Idec)	No disclosure on file
James Potts	No disclosure on file

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