Prolonged-release Fampridine post-marketing experience in Alsace, France. (P1.126)

OBJECTIVE: Prolonged-release fampridine is licensed in European Union (EU) for the improvement of walking in patients with multiple sclerosis (MS). This oral form of potassium channel-blocking drug may improve conduction in the central nervous system by increasing genesis of action potentials. In this study, we provide a descriptive analysis of the post-marketing efficacy and safety of fampridine in MS patients in our region (Alsace, France). DESIGN/METHODS: Descriptive analysis data were extracted from the EDMUS data base (European Database for MS) since the product is available in clinical practice. The primary endpoint was the proportion of Timed-Walk Responders (TWR), defined as patients whose walking speed was faster at D15 visit compared to inclusion visit (baseline/D0). MSWS-12 score was also analyzed during this period. RESULTS: Three hundred and eighty nine patients treated by fampridine were included in this study: the patients were aged from 28 to 80 years and had a mean EDSS score (Expanded Disability Status Scale) of 5.9 (SD 0.9) at baseline. The number of patients who met the responder criteria was 295 of 389 (75.8[percnt]). During the efficacy analysis period (D0 to D15), the average change in walking speed for responder patients was 29.2[percnt] (95[percnt] CI, 25.5 - 32.9[percnt]) or 0,61 ft/s compared to change of 4.5[percnt] (95[percnt] CI, 1.3 -7.5[percnt]) or 0.1 feet/s in nonresponder patients. Tolerance of the fampridine is overall satisfactory. Tolerability was consistent with that observed in double-blind clinical studies; no new safety signals emerged in our study. CONCLUSIONS: In our cohort, 76[percnt] of patients met responder criteria. The average improvement in walking speed during efficacy period was 29.2[percnt] for the responders compared to 4.5[percnt] for nonresponders patients. Moreover, during the efficacy analysis period, the average change in walking speed for responder patients correlates with the average change from baseline in MSWS-12 auto-questionnaire score. Disclosure: Dr. Berthe has nothing to disclose. Dr. Ongagna has nothing to disclose. Dr. Courtois has nothing to disclose. Dr. Gaultier has nothing to disclose. Dr. Kopf has nothing to disclose. Dr. Fleury has nothing to disclose. Dr. Benoilid has nothing to disclose. Dr. nicolas has nothing to disclose. Dr. Blanc has nothing to disclose. Dr. Zaenker has nothing to disclose. Dr. De Seze has nothing to disclose.