Tolerance and Efficacy of FampyraÃ‚Â® in Real-Life Cohort of Patients with Multiple Sclerosis
|Ongagna JC1, Berthe C2, Courtois S3, Gaultier C4, Kopf A1, Fleury M-C2, Benoilid A1, Collongues N2, Blanc F2, Zaenker C1 and de Seze J1,2*|
|1alSacEP network, Pasteur hospital, 39, avenue de la Liberté, 68024, Colmar, France|
|2Department of Neurology, University, hospital, 1, avenue Molière, 67098, Strasbourg, France|
|3Department of Neurology E. MULLER hospital, 20, avenue du Dr René Laennec, 68100 Mulhouse, France|
|4Department of Neurology, Pasteur hospital, 39, avenue de la Liberté, 68024 Colmar, France|
|Corresponding Author :||Jérôme de Seze
Department of Neurology
University hospital, 1, avenue Molière
67098, Strasbourg, France
Tel: +33 3 88 12 85 43
Fax: +33 3 88 12 85 33
E-mail: [email protected]
|Received: July 01, 2015; Accepted: September 21, 2015; Published: October 05, 2015|
|Citation: Ongagna JC, Berthe C, Courtois S, Gaultier C, Kopf A, et al. (2015) Tolerance and Efficacy of Fampyra® in Real-Life Cohort of Patients with Multiple Sclerosis. J Clin Cell Immunol 6:355. doi:10.4172/2155-9899.1000355|
|Copyright: © 2015 Ongagna JC, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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Background: Prolonged-release Fampridine is a selective potassium channel blocker licensed for the improvement of walking in adult patients diagnosed with multiple sclerosis (MS). The objective of this study was to evaluate the efficacy and safety of prolonged-release Fampridine in our regional MS cohort.
Methods: Descriptive analysis data of Prolonged-release Fampridine (10 mg twice daily) patients were extracted from the European Database for Multiple Sclerosis (EDMUS) for the period since Fampridine became available in clinical practice. Data were collected on all patients in Alsace region of France. The patients had a mean EDSS score of 5.5 at baseline. The primary outcome was to determine the proportion of timed-walk responders at day compared to day 0 (baseline). The secondary outcome was the amplitude of this response in terms of time to walk and the 12-item Multiple Sclerosis Walking Scale (MSWS-12) score. Additional analysis was conducted to determine the incidence of reported adverse events. The proportion of AE reports was estimated by event, as classified at the MedDRA preferred term level. Commonly reported AEs were defined as those with a prevalence ≥ 2% of all reported AES.
Results: Of 467 patients who received Fampyra® 453, 332 women (73.3%) and 121 men (26.7%), were included in the study. The proportion of patients in this cohort who were classed as responders was 73.5% (333 of 453). Responders walked 8 sec faster at day 15 compared to baseline (18.0 ± 12.9 sec versus 25.6 ± 22.2 sec; p<0.001). The average improvement from baseline for the responders was 30.2% for walking speed and 33.1 for the MSWS-12).
Conclusions: Our study confirms the efficacy of Fampridine with a high level of responders (73%). The intensity of the improvement concerning walking capacity was around 30% for both evaluations (walking speed and MSWS-12 score). In view of the low level of side effects the benefit/risk ratio of Fampridine appears favorable.