REALMS study: real-world effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis
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ORIGINAL ARTICLE
REALMS study: real-world effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis in Portugal S. Batista 1 & C. C. Nunes 1 & J. J. Cerqueira 2,3 & Ana Martins Silva 4,5 & J. Correia de Sá 6 & J. Ferreira 6 & M. T. Mendonça 7 & J. Pinheiro 8 & V. Salgado 9 & A. S. Correia 10 & J. Sequeira 11 & A. Costa 12 & L. Sousa 1 Received: 28 December 2019 / Accepted: 15 September 2020 # Fondazione Società Italiana di Neurologia 2020
Abstract Background Fingolimod, an oral sphingosine 1-phosphate receptor modulator, is approved by EMA for relapsing-remitting multiple sclerosis (RRMS). Objectives To assess the effectiveness and safety of fingolimod in patients with RRMS in real-world clinical practice in Portugal. Methods Retrospective, 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. Results Two-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. Conclusions Therapy 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. Keywords Relapsing-remitting multiple sclerosis . Real-world study . Fingolimod . ARR . EDSS . Safety
Introduction 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], although some authors
consider it to be an immunosuppressant [2]. It is a prodrug that is phosphorylated by sphingosine kinases to its active form, phosphofingolimod [1]. 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
S. Batista and C. C. Nunes contributed equally to this work. * S. Batista [email protected] 1
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Centro Hospitalar e Universitário de Coimbra, Praceta Prof. Mota Pinto, 3000-075 Coimbra, Portugal Hospital de Braga, Braga, Portugal
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Centro Hospitalar Lisboa Norte E.P.E., Hospital de Santa Maria, Lisbon, Portugal
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Centro Hospitalar São João, Porto, Portugal
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Centro Hospitalar Vila Nova Gaia, Vila Nova de Gaia, Portugal
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Hospital Prof. Doutor Fernando Fonseca E.P.E.,
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