Irene Sanchez-Vera
Novartis Farmaceutica S.A., Spain
Title: Effectiveness of fingolimod in patients with relapsing-remitting multiple sclerosis in daily clinical practice in Spain: Results from a multivariate pool analysis called Fingoview
Biography
Biography: Irene Sanchez-Vera
Abstract
Introduction: Once-daily Fingolimod (Gilenya®, Novartis Pharma AG) is a sphingosine 1-phosphate receptor modulator approved for relapsing MS treatment. Continuous collection and analysis of real world effectiveness and safety data is the key to making accurate treatment decisions. The objective is to describe basal characteristics and effectiveness of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) followed for ≥12 months in routine clinical practice in Spain.
Methods: Fingoview is a multivariate pool analysis of two observational, retrospective chart reviews, multicenter studies MS Second Line Gate and MS Next, conducted in specialized MS centers in Spain, between November 2014 and December 2015. Pool analysis was prospectively planned. Both studies included patients of both sexes, ≥18 years, diagnosed with RRMS, treated with fingolimod according to SmPC and followed up for ≥12 months after treatment initiation.
Results: Fingoview included 988 patients (70 naïve, 252 post-natalizumab, 666 post first-line injectable DMTs), 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<0.0001). At 12 months, 89.6% of patients had stable or improved EDSS which was maintained in 84.4% of patients at 24 months. New/enlarged T2 lesions, gadolinium-enhancing lesions on T1 or radiologically disease free will be discussed.
Conclusion: After switching to fingolimod, RRMS had significantly suppressed clinical disease activity and most of the patients have a stable EDSS after one year of treatment.