Abstract
BackgroundFingolimod, an oral sphingosine 1-phosphate receptor modulator, is approved by EMA for relapsing-remitting multiple sclerosis (RRMS).ObjectivesTo assess the effectiveness and safety of fingolimod in patients with RRMS in real-world clinical practice in Portugal.MethodsRetrospective, multicentre, non-interventional study, reporting 3 years follow-up of data collected from October 2015 to July 2016. Sociodemographic data and previous treatments at baseline and data regarding disease evolution, including number of relapses, annualised relapse rates (ARR) and Expanded Disability Status Scale (EDSS), were collected.ResultsTwo-hundred and seventy-five participants were enrolled in the REALMS study. Results showed that the main reason to switch to fingolimod was failure of previous treatment (56.7%) and only 3.6% were naïve patients. In the total population, there was a significant decrease in ARR of 64.6% in the first year of treatment, 79.7% in the second year and 82.3% in the third year, compared with baseline. More than 67.0% of patients had no relapses during the 3 years after switching to fingolimod. EDSS remained stable throughout the study.ConclusionsTherapy with fingolimod showed a sustained effectiveness and safety over the 3 years, particularly on patients switched from first-line drugs (BRACE). No new safety issues were reported.
Highlights
Fingolimod belongs to a class of drugs that targets the sphingolipid-regulated signaling system, acting as a functional antagonist of the sphingosine-1-phosphate type 1 (S1P1) receptor immunomodulatory [1], some authors consider it to be an immunosuppressant [2]
Inclusion criteria were as follows: age 18 years or more; diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the McDonald Criteria from 2010 [16]; patients who had initiated treatment with fingolimod at least 12 months before study enrolment, including those previously treated with interferon-β and/or glatiramer acetate, natalizumab or treatment naïve; at least 12 months of follow-up after initiating fingolimod treatment and sufficient data available on the clinical files
This paper reports 3-year follow-up of data collected from the 9 participating centres throughout Portugal from October 2015 to July 2016
Summary
Fingolimod belongs to a class of drugs that targets the sphingolipid-regulated signaling system, acting as a functional antagonist of the sphingosine-1-phosphate type 1 (S1P1) receptor immunomodulatory [1], some authors consider it to be an immunosuppressant [2]. S1P1 is expressed abundantly on T and B lymphocytes, and fingolimod induces its downregulation by sequestering T cells in lymph nodes. This action prevents these cells from infiltrating inflammatory lesions in. Fingolimod, an oral sphingosine 1-phosphate receptor modulator, is approved by EMA for relapsing-remitting multiple sclerosis (RRMS). Sociodemographic data and previous treatments at baseline and data regarding disease evolution, including number of relapses, annualised relapse rates (ARR) and Expanded Disability Status Scale (EDSS), were collected. Results showed that the main reason to switch to fingolimod was failure of previous treatment (56.7%) and only 3.6% were naïve patients. More than 67.0% of patients had no relapses during the 3 years after switching to fingolimod.
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