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

2021-05Journal article Open access
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dc.contributor.authorBatista, S.
dc.contributor.authorNunes, C. C.
dc.contributor.authorCerqueira, J. J.
dc.contributor.authorMartins da Silva, Ana
dc.contributor.authorCorreia de Sá, J.
dc.contributor.authorFerreira, J.
dc.contributor.authorMendonça, M. T.
dc.contributor.authorPinheiro, J.
dc.contributor.authorSalgado, V.
dc.contributor.authorCorreia, A. S.
dc.contributor.authorSequeira, J.
dc.contributor.authorCosta, A.
dc.contributor.authorSousa, L.
dc.date.accessioned2023-10-24T10:20:01Z
dc.date.available2023-10-24T10:20:01Z
dc.date.issued2021-05
dc.description.abstractackground: 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.sponsorshipThis study was funded by Novartis Pharma, Portugal.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationBatista S, Nunes CC, Cerqueira JJ, et al. REALMS study: real-world effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis in Portugal [published correction appears in Neurol Sci. 2020 Nov 9;:]. Neurol Sci. 2021;42(5):1995-2003. doi:10.1007/s10072-020-04726-6pt_PT
dc.identifier.doi10.1007/s10072-020-04726-6pt_PT
dc.identifier.issn1590-1874
dc.identifier.issn1590-3478
dc.identifier.urihttp://hdl.handle.net/10400.16/2844
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSpringer-Verlag Italiapt_PT
dc.relation.publisherversionhttps://link.springer.com/article/10.1007/s10072-020-04726-6pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/pt_PT
dc.subjectARR; EDSSpt_PT
dc.subjectFingolimod; Real-world studypt_PT
dc.subjectRelapsing-remitting multiple sclerosispt_PT
dc.subjectSafetypt_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.conferencePlaceItalypt_PT
oaire.citation.endPage2003pt_PT
oaire.citation.issue5pt_PT
oaire.citation.startPage1995pt_PT
oaire.citation.titleNeurological Sciencespt_PT
oaire.citation.volume42pt_PT
person.familyNameMartins da Silva
person.givenNameAna
person.identifier.ciencia-id1116-6606-5CF5
person.identifier.orcid0000-0002-1409-0831
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicatione2fd5aa2-f733-43eb-b339-14fcaa3d881d
relation.isAuthorOfPublication.latestForDiscoverye2fd5aa2-f733-43eb-b339-14fcaa3d881d

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