I Correia1, S Batista2, I B Marques2, M Sousa2, R Ferreira3, C Nunes2, M C Macário2, L Sousa2. 1. Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Av. Bissaya Barreto-Praceta Prof. Mota Pinto, 3000-075 Coimbra, Portugal. Electronic address: mcorreia.ines@gmail.com. 2. Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Av. Bissaya Barreto-Praceta Prof. Mota Pinto, 3000-075 Coimbra, Portugal. 3. Department of Internal Medicine, Centro Hospitalar e Universitário de Coimbra, Av. Bissaya Barreto-Praceta Prof. Mota Pinto, 3000-075 Coimbra, Portugal.
Abstract
INTRODUCTION: Fingolimod is an oral treatment for Relapsing-Remitting Multiple Sclerosis (RRMS) with established efficacy in clinical trials. Post-marketing studies are important to assess its effectiveness in real-world populations. OBJECTIVES: To report the effectiveness and safety of fingolimod in a real-world population. METHODS: A retrospective study of patients with RRMS treated with fingolimod for at least six months. The demographic characteristics, Annualized Relapse Rate (ARR), Expanded Disability Status Score (EDSS), previous treatments and Adverse Events (AE) were analysed. RESULTS: 104 patients were included, with a mean treatment duration of 21.06 months. First-line disease modifying therapy failure patients (n=56) had an ARR decrease of 68.53% (1.43 vs. 0.45, p<0.001), 66.07% of them were relapse-free, EDSS significantly decreased (2.5 vs. 2.0, p<0.001) and 91.07% showed no disability progression. In patients previously treated with natalizumab as a second-line drug mainly switched due to safety concerns (n=41), although the differences were not statistically significant, both the ARR and EDSS increased in 41.46% and 19.51% of patients, respectively. In treatment-naive patients (n=7) the ARR decreased 94.90% (1.57 vs. 0.08, p=0.027) and there was no disability progression. 56.7% of all patients experienced AE not considered serious in any of the cases. CONCLUSION: In this population, fingolimod was an effective treatment after first-line treatment failure, decreasing both the ARR and EDSS, and may be an effective option after natalizumab.
INTRODUCTION:Fingolimod is an oral treatment for Relapsing-Remitting Multiple Sclerosis (RRMS) with established efficacy in clinical trials. Post-marketing studies are important to assess its effectiveness in real-world populations. OBJECTIVES: To report the effectiveness and safety of fingolimod in a real-world population. METHODS: A retrospective study of patients with RRMS treated with fingolimod for at least six months. The demographic characteristics, Annualized Relapse Rate (ARR), Expanded Disability Status Score (EDSS), previous treatments and Adverse Events (AE) were analysed. RESULTS: 104 patients were included, with a mean treatment duration of 21.06 months. First-line disease modifying therapy failurepatients (n=56) had an ARR decrease of 68.53% (1.43 vs. 0.45, p<0.001), 66.07% of them were relapse-free, EDSS significantly decreased (2.5 vs. 2.0, p<0.001) and 91.07% showed no disability progression. In patients previously treated with natalizumab as a second-line drug mainly switched due to safety concerns (n=41), although the differences were not statistically significant, both the ARR and EDSS increased in 41.46% and 19.51% of patients, respectively. In treatment-naive patients (n=7) the ARR decreased 94.90% (1.57 vs. 0.08, p=0.027) and there was no disability progression. 56.7% of all patients experienced AE not considered serious in any of the cases. CONCLUSION: In this population, fingolimod was an effective treatment after first-line treatment failure, decreasing both the ARR and EDSS, and may be an effective option after natalizumab.