Safety and efficacy in patients receiving natalizumab therapy in Hungary (P6.330)

Objective: To assess the real-life effectiveness of natalizumab in structured patient follow-up. Background: Natalizumab has been recommended for the treatment of relapsing-remitting multiple sclerosis (RRMS) in patients with insufficient response to first line immunomodulatory treatment (IMT) or in aggressive MS. Design/Methods: A protocol for prospective long-term safety follow-up was established to manage patients treated with natalizumab in Hungary. The observational study included all RRMS patients on natalizumab therapy and registered via the IMed database system from 2010. The MS-database contains the following data from the baseline and regularly controlled: EDSS-score, MRI, MSQoL54, MSFC, JCV status, laboratory data. Statistical analyses were performed using SPSS software. Results: 319 RRMS (8.4%) out of 3802 total IMT patients were treated with natalizumab in 2015. The mean age was 40±8.9 year with 8.7±6 year disease duration from onset at start of natalizumab treatment. The mean duration of natalizumab treatment at the time of analysis was 3.3±1.7 years. There was a decrease in ARR of 0.77 during 12 months of natalizumab treatment (p Conclusions: Patients switched to natalizumab following previous insufficient response to first line IMT have marked reduction of measurable clinical, MRI disease activity and natalizumab preserves cognitive function. Disclosure: Dr. Csepany has nothing to disclose. Dr. Lovas has nothing to disclose. Dr. Bencsik has nothing to disclose. Dr. Rozsa has nothing to disclose. Dr. Simo has nothing to disclose. Dr. Kovacs has nothing to disclose. Dr. Komoly has nothing to disclose. Dr. Barsi has nothing to disclose. Dr. Mor has nothing to disclose.