Effectiveness of fingolimod in patients with relapsing-remitting multiple sclerosis in daily clinical practice in Spain: Results from a multivariate pool analysis called Fingoview

Objective: To describe basal characteristics and effectiveness variables of patients with relapsing-remitting multiple sclerosis (RRMS) treated with fingolimod and followed for ≥12 months in routine clinical practice in Spain. Background: Once-daily fingolimod (Gilenya®, Novartis Pharma AG) is a sphingosine 1-phosphate receptor modulator approved for relapsing MS treatment. Over 154,000 patients have received fingolimod treatment; total patient exposure exceeds 343,000 patient-years. Continuous collection and analysis of real world effectiveness and safety data is key to making accurate treatment decisions. Design/Methods: Multivariate pooled analysis of two observational, retrospective, multicenter studies, conducted in Spain, denoted as MS SECOND LINE GATE and MS NEXT. Both studies were carried out in RRMS patients of both sexes, ≥18 years, reated with 0.5mg/day of fingolimod and followed up for ≥12 months after treatment initiation. These studies were performed between November 2014 and December 2015. Results: Multivariate pooled analysis was performed by combining different ranges of the covariates sex, age, annual relapse rate (ARR) and baseline EDSS. In total, 96 different combinations of these covariates were analysed. Fingoview included 988 patients (70 naive, 252 post-natalizumab, 666 post-BRACE), 68.9% female, mean (SD) age: 40.44 (9.1) years. After 1, 2, 3 years of treatment mean annual relapse rate decreased by 76.5% (mean: 1.19 to 0.28), 82.4% (0.21) and 86.3% (0.16) compared to the year prior to fingolimod (all p Conclusions: After switching to fingolimod, RRMS patients experienced significantly lower clinical disease activity and most of the patients shared a stable EDSS after one year of treatment. The extensive multivariate analysis will show whether differences in clinical outcomes of treatment with fingolimod are associated to differences in baseline characteristics of the patients. Study Supported by: Novartis Farmaceutica S.A. Disclosure: Dr. Meca Lallana has nothing to disclose. Dr. Izquierdo has received personal compensation for activities with Biogen Idec, Merck Serono, Sanofi Pharmaceuticals, Teva Neuroscience, Novartis, Genzyme Corporation, Almirall and Roche Diagnostics Corporation as a speaker and consultant. Dr. Ara has received personal compensation for activities with Bayer, Biogen, Sanofi Genzyme, EMD Serono, Novartis, Sanofi-Aventis and Teva CNS as a consultant and/or speaker. Dr. Oreja Guevara has received personal compensation for activities with Biogen Idec, Novartis, Sanofi Genzyme, Roche Diagnostics Corporation, Merck, and Teva Neuroscience. Dr. Diaz has received personal compensation for activities with Novartis, Biogen, and Sanofi-Genzyme as a speaker. Dr. Diaz has received research support from Biogen and Sanofi-Genzyme. Dr. Ayuso has received personal compensation for activities with Biogen, Sanofi, Teva, and Bayer. Dr. Sempere has received personal compensation for activities with Biogen Idec, Bayer Schering Pharma, Merck Serono, Novartis, Sanofi-Aventis and Teva CNS. Dr. Herrera has received personal compensation for activities with Teva, Sanofi, Novartis and Biogen as a speaker. Dr. Contreras has received personal compensation for activities with Biogen, Sanofi, Novartis, Teva and Bayer. Dr. Sanchez-Vera has received personal compensation for activities with Novartis as an employee. Dr. Moreno Jimenez has received personal compensation for activities with Novartis Pharmaceuticals as an employee. Dr. Ricart has received personal compensation for activities with Novartis as an employee. Dr. Garcia has received personal compensation for activities with Novartis as an employee.