Efficacy of Natalizumab and Fingolimod in Relapsing Remitting Multiple Sclerosis in Real World Clinical Setting: a 2-year follow-up (P6.377)

Objective: The aim of this multicenter study was to compare the efficacy of natalizumab and fingolimod for relapsing-remitting multiple sclerosis (RR-MS) patients in a real-world clinical setting after 2-year of follow-up. Background: Natalizumab and fingolimod are established second-line treatment RR-MS; yet, no head-to-head trials have been conducted so far and only few observational studies compared their efficacy in a real-life setting. Design/Methods: Three-hundred-ninety-one patients starting either natalizumab (n=197) or fingolimod (n=194) for RR-MS (F=264, M=127, mean age=36.7±9.4ys) and referred to four MS centers between March 2007 and July 2013 were prospectively enrolled. No differences were noted in terms of disease duration (mean ±9.4, P=0.143) and EDSS score (mean 2.9±1.1, P=0.099) between groups, though natalizumab cohort had both higher ARR (1.9±0.7 vs 1.1±0.7, P Results: The proportion of patients achieving NEDA-3 was 72.0% in natalizumab and 59.1% in fingolimod group at 1-year follow-up and 71.3% vs. 46.3% at 2-year follow up. Multivariate logistic regression analysis showed that natalizumab (B=−0.787, P=0.001) and baseline EDSS values (B=−0.315, P=0.008) positively influenced the probability to remain disease free. Patients with baseline higher values of EDSS or patients treated with natalizumab had lower incidence of disease activity. Conclusions: Results from 2-year follow-up of treatment suggest sustained efficacy of both treatment strategies with significantly more patients reaching NEDA-3 in the natalizumab cohort. Disclosure: Dr. Totaro has received personal compensation for activities with Bayer Schering Pharma, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis, and Teva as a speaker. Dr. Costantino has received personal compensation for activities with Bayer Schering Pharma, Biogen Idec, Merck Serono, Novartis, and Sanofi-Aventis for travel funding or speaker honoraria. Dr. Danni has nothing to disclose. Dr. Bellantonio has nothing to disclose. Dr. Di Carmine has nothing to disclose. Dr. Fantozzi has nothing to disclose. Dr. Cerqua has received personal compensation for activities with Sanofi Genzyme, Biogen Idec, Teva, EMD Serono and Novartis. Dr. Fuiani has nothing to disclose. Dr. Mundi has nothing to disclose. Dr. Marini has nothing to disclose. Dr. Centonze has received personal compensation from Almirall, Bayer Schering, Biogen Idec, Genzyme, GW Pharmaceuticals, Merck Serono, Novartis, Sanofi-Aventis and Teva as a speaker and/or consultant. Dr. Provinciali has nothing to disclose. Dr. Carolei has nothing to disclose.