DI-097 Effectiveness evaluation of fampridine in patients with multiple sclerosis

Abstract

Background Fampridine is indicated to improve walking in adult patients with multiple sclerosis (MS) and an expanded disability status scale (EDSS) score of 4–7. In order to evaluate continuation of treatment, there should be at least an improvement of 20% in their timed 25 foot walk test (T25FW) after taking the drug for 2 weeks. Purpose To evaluate effectiveness and safety of fampridine after 2 weeks of treatment in patients with MS in clinical practice comparing our results with those observed in the MS-F203 and MS-F204 pivotal trials. Material and methods An observational retrospective study was carried out in a cohort of patients (n=55) with MS and EDSS (4–7), treated with fampridine from September 2015 to March 2016). Digitised medical records were obtained (Diraya). Variables were age, type of MS, EDSS, T25FW result at baseline and at 2 weeks, and adverse effects (safety). The response criteria were defined as ≥20% improvement in T25FW. Results 55 patients were included in the study. Median age was 48 years (34–66), and 71% were women. 44% of patients had relapsing remitting MS, 31% had secondary progressive MS and 25% had primary progressive MS. Median EDSS was 6. The average speed of T25FW at baseline was 39.6 cm/s (0.2 to 108.8) and 62.0 cm/s (15.4 to 148.5) after 14 days of treatment, representing a mean difference of 22.47 cm/s. 80% of patients had an improvement >20% after 2 weeks. 11 patients discontinued after the trial period due to lack of improvement. 20% of patients experienced some sort of adverse effect: instability and lack of coordination (5.4%), headache (3.6%), gastrointestinal disorders (3.6%), dizziness (3.6%), skin injuries (3.6%), insomnia (1.8%), aggression (1.8%) and dizziness (1.8%). Conclusion Fampridine is proving to be an effective way to increase walking speed with a low incidence of adverse effects. In our study, compared with clinical trials, the results were superior (response rate 80% versus 34.8% and 42.9%), the difference observed between the results leading us to reconsider the objectivity used to assess effectiveness of this drug. References and/or acknowledgements Technical sheet fampridine. No conflict of interest