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REALMS study: real-world effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis in Portugal

2020Journal article Restricted access
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dc.contributor.authorBatista, S
dc.contributor.authorNunes, C
dc.contributor.authorCerqueira, J
dc.contributor.authorSilva, A
dc.contributor.authorSá, J
dc.contributor.authorFerreira, J
dc.contributor.authorMendonça, M
dc.contributor.authorPinheiro, J
dc.contributor.authorSalgado, V, et al.
dc.date.accessioned2020-11-10T16:05:45Z
dc.date.available2020-11-10T16:05:45Z
dc.date.issued2020
dc.description.abstractBackground: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationNeurol Sci . 2020 Sep 30.pt_PT
dc.identifier.doi10.1007/s10072-020-04726-6pt_PT
dc.identifier.issn1590-3478
dc.identifier.urihttp://hdl.handle.net/10400.10/2504
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSpringer-Verlagpt_PT
dc.subjectMultiple sclerosispt_PT
dc.subjectRelapsing-remitting multiple sclerosispt_PT
dc.subjectFingolimodpt_PT
dc.subjectPortugalpt_PT
dc.subjectREALMS studypt_PT
dc.titleREALMS study: real-world effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis in Portugalpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.conferencePlaceMilanopt_PT
oaire.citation.titleNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology.pt_PT
rcaap.rightsclosedAccesspt_PT
rcaap.typearticlept_PT

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