The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study

Sousa, L.; de Sa, J.; Sa, M.; Cerqueira, J.; Martins-Silva, A.

Publication

The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study

2014-11-01Journal article

dc.contributor.author	Sousa, L.
dc.contributor.author	de Sa, J.
dc.contributor.author	Sa, M.
dc.contributor.author	Cerqueira, J.
dc.contributor.author	Martins-Silva, A.
dc.date.accessioned	2015-11-02T13:54:14Z
dc.date.available	2015-11-02T13:54:14Z
dc.date.issued	2014-11-01
dc.description.abstract	INTRODUCTION: Studies have shown that natalizumab is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). To date, no data are available in Portuguese patients. AIM: To determine the efficacy and safety of natalizumab in patients with RRMS in routine clinical practice in Portugal. PATIENTS AND METHODS: Clinical data for adult patients with RRMS treated with natalizumab at specialist neurology centres in Portugal were entered retrospectively into a database for analysis between October 2010 and February 2012. Changes in annualized relapse rates (ARR), Expanded Disability Status Scale (EDSS) scores and disability status were analysed. RESULTS: A total of 383 patients from 20 centres were included. Prior to starting natalizumab, the baseline median EDSS score was 4 and the mean ARR was 1.64. Most patients had previously received multiple sclerosis treatment (93.0%). Median natalizumab treatment duration was 12 months. Natalizumab treatment was associated with significant (p < 0.001) reductions from baseline in the mean ARR and EDSS scores in patients treated with natalizumab for >= 12 months (n = 288) and for >= 24 months (n = 160). Natalizumab was more effective in patients with less disability (EDSS < 3) and in those who had not previously received disease-modifying treatments. Two cases of progressive multifocal leukoencephalopathy were reported. No new unexpected adverse events occurred. CONCLUSION: Natalizumab is well tolerated, and is effective in reducing relapse rate and stabilising disease in patients with RRMS in the clinical practice setting in Portugal. Its efficacy persists with continued treatment, and it may be particularly effective in patients with less disability and without prior disease modifying therapy.	pt_PT
dc.description.abstract	Introduccion. Los estudios han demostrado que el natalizumab constituye un tratamiento eficaz contra la esclerosis multiple remitente recurrente (EMRR). Hasta la fecha, no habia datos de pacientes portugueses. Objetivo. Determinar la eficacia y la seguridad del natalizumab en pacientes con EMRR atendidos en la practica clinica ordinaria en Portugal. Pacientes y metodos. Los datos clinicos de adultos con EMRR tratados con natalizumab en centros especializados de neurologia en Portugal se introdujeron de forma retrospectiva en una base de datos para llevar a cabo un analisis entre octubre de 2010 y febrero de 2012. Se analizo el cambio en la tasa anualizada de brotes (TAB), en las puntuaciones de la escala ampliada de discapacidad (EDSS) y en el estado de discapacidad. Resultados. Se admitio un total de 383 pacientes atendidos en 20 centros. Antes de iniciar el tratamiento con natalizumab, la mediana inicial de la EDSS era de 4,0 y la TAB media, de 1,64. La mayor parte de los pacientes ya habia recibido tratamiento contra la esclerosis multiple (93,0%). La duracion media del tratamiento con natalizumab era de 12 meses. El tratamiento propicio reducciones significativas (p < 0,001) de los valores iniciales de la TAB media y de las puntuaciones EDSS en los tratados con el anticuerpo durante >= 12 meses (n = 288) y durante >= 24 meses (n = 160). El natalizumab resulto mas eficaz en los pacientes que presentaban un menor grado de discapacidad (EDSS < 3,0) y en los que no habian recibido ningun tratamiento modificador de la enfermedad. Se notificaron dos casos de leucoencefalopatia multifocal progresiva. No hubo efectos adversos inesperados. Conclusion. El natalizumab presenta una tolerabilidad satisfactoria y se muestra eficaz en la reduccion de las recidivas y la estabilizacion de la EMRR en el marco de la practica clinica ordinaria en Portugal. Conserva su eficacia con el tratamiento continuado y podria ser eficaz especialmente en los pacientes con menos discapacidad y en aquellos que no han recibido ningun tratamiento modificador de la enfermedad hasta el momento.	pt_PT
dc.identifier.citation	Rev Neurol 2014; 59 (9): 399-406	pt_PT
dc.identifier.issn	0210-0010
dc.identifier.uri	http://hdl.handle.net/10400.16/1876
dc.language.iso	eng	pt_PT
dc.peerreviewed	yes	pt_PT
dc.publisher	Cesar Viguera	pt_PT
dc.relation.publisherversion	http://www.revneurol.com/sec/resumen.php?or=pubmed&id=2013479#	pt_PT
dc.subject	Demyelinating autoimmune diseases	pt_PT
dc.subject	Multiple sclerosis	pt_PT
dc.subject	Natalizumab	pt_PT
dc.subject	Progressive multifocal leukoencephalopathy	pt_PT
dc.subject	Relapse rate	pt_PT
dc.subject	Retrospective study	pt_PT
dc.subject	Enfermedades autoinmunitarias desmielinizantes	pt_PT
dc.subject	Esclerosis múltiple	pt_PT
dc.subject	Estudio retrospectivo	pt_PT
dc.subject	Leucoencefalopatía multifocal progresiva	pt_PT
dc.subject	Natalizumab	pt_PT
dc.subject	Tasa de brotes	pt_PT
dc.title	The efficacy and safety of natalizumab for the treatment of multiple sclerosis in Portugal: a retrospective study	pt_PT
dc.title.alternative	Estudio retrospectivo de la eficacia y seguridad del natalizumab en el tratamiento de la esclerosis múltiple en Portugal	pt_PT
dc.type	journal article
dspace.entity.type	Publication
oaire.citation.conferencePlace	Spain	pt_PT
oaire.citation.endPage	406	pt_PT
oaire.citation.startPage	399	pt_PT
oaire.citation.title	Revista de neurologia	pt_PT
oaire.citation.volume	59(9)	pt_PT
rcaap.rights	openAccess	pt_PT
rcaap.type	article	pt_PT