音声学と聴覚学ジャーナル
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概要

Tolerance and Efficacy of Fampyra® in Real-Life Cohort of Patients with Multiple Sclerosis

Ongagna JC, Berthe C, Courtois S, Gaultier C, Kopf A, Fleury M-C, Benoilid A, Collongues N, Blanc F, Zaenker C and de Seze J

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.