000089578 001__ 89578
000089578 005__ 20210902121630.0
000089578 0247_ $$2doi$$a10.1371/journal.pone.0230846
000089578 0248_ $$2sideral$$a117588
000089578 037__ $$aART-2020-117588
000089578 041__ $$aeng
000089578 100__ $$aBarrero, F.
000089578 245__ $$aSpanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study
000089578 260__ $$c2020
000089578 5060_ $$aAccess copy available to the general public$$fUnrestricted
000089578 5203_ $$aPurpose
The objective of this study was to characterize the demographic and clinical profile of RRMS patients receiving fingolimod in Spain, and to evaluate drug effectiveness and safety in clinical practice.
Methods
This observational, retrospective, multicentre, nationwide study was performed at 56 Spanish hospitals and involved 804 RRMS patients who received oral fingolimod (0.5 mg) since November 2011, with a minimum follow-up of 12 months.
Results
The mean annualized relapse rate (ARR) in the year before fingolimod was 1.08 and the median EDSS was 3; patients were exposed to fingolimod for 2.2 years as average; regarding magnetic resonance imaging (MRI) activity, more than half of the patients had >20 lesions at baseline. Patients were previously treated with first-line injectable DMTs (60.3%), or natalizumab (31.3%), and 8.3% were naïve patients. Overall, the ARR significantly decreased to 0.28, 0.22 and 0.17 (74.1%, 79.7% and 83.5% of relative reduction, respectively) after 12, 24 and 36 months of treatment, P<0.001. The ARR of patients who switched from natalizumab to fingolimod was stable over the study. Most of the patients (88.7%) were free from confirmed disability and MRI activity (67.3%) after 24 months. The persistence after 12 months on fingolimod was 93.9%.
Conclusions
The subgroups of patients analysed showed differential baseline demographic and clinical characteristics. The analysis of patients who received fingolimod in routine clinical practice confirmed adequate efficacy and safety, even for long-term treatment. The present data also confirmed the positive benefit/risk balance with fingolimod in real-world clinical practice setting.
000089578 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000089578 590__ $$a3.24$$b2020
000089578 591__ $$aMULTIDISCIPLINARY SCIENCES$$b26 / 73 = 0.356$$c2020$$dQ2$$eT2
000089578 592__ $$a0.99$$b2020
000089578 593__ $$aMultidisciplinary$$c2020$$dQ1
000089578 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000089578 700__ $$aMallada-Frechin, J.
000089578 700__ $$aMartínez-Ginés, M.L.
000089578 700__ $$aMarzo, M.E.
000089578 700__ $$aMeca-Lallana, V.
000089578 700__ $$aIzquierdo, G.
000089578 700__ $$0(orcid)0000-0002-9788-2083$$aAra, J.R.
000089578 700__ $$aOreja-Guevara, C.
000089578 700__ $$aMeca-Lallana, J.
000089578 700__ $$aForero, L.
000089578 700__ $$aSánchez-Vera, I.
000089578 700__ $$aMoreno, M.J.
000089578 700__ $$ain, representation, of, the, MS, NEXT, study, investigators
000089578 773__ $$g15, 4 (2020), e0230846 [13 pp]$$pPLoS One$$tPloS one$$x1932-6203
000089578 8564_ $$s684723$$uhttps://zaguan.unizar.es/record/89578/files/texto_completo.pdf$$yVersión publicada
000089578 8564_ $$s457089$$uhttps://zaguan.unizar.es/record/89578/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000089578 909CO $$ooai:zaguan.unizar.es:89578$$particulos$$pdriver
000089578 951__ $$a2021-09-02-08:52:32
000089578 980__ $$aARTICLE