Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis

Clemens Warnke1,2, Olaf St&uuml;ve3,4, Hans-Peter Hartung1, Anna Fogdell-Hahn2, Bernd C Kieseier11Department of Neurology, Heinrich-Heine-University, D&uuml;sseldorf, Germany; 2Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden; 3Department of Neurology, Dal...

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Autores principales:	Warnke C, St&uuml;ve O, Hartung HP, Fogdell-Hahn A, Kieseier B
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/1f40c5bda7594a358c550787481ca194
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spelling	oai:doaj.org-article:1f40c5bda7594a358c550787481ca1942021-12-02T09:28:03ZCritical appraisal of the role of fingolimod in the treatment of multiple sclerosis1176-63281178-2021https://doaj.org/article/1f40c5bda7594a358c550787481ca1942011-09-01T00:00:00Zhttp://www.dovepress.com/critical-appraisal-of-the-role-of-fingolimod-in-the-treatment-of-multi-a8235https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Clemens Warnke1,2, Olaf St&uuml;ve3,4, Hans-Peter Hartung1, Anna Fogdell-Hahn2, Bernd C Kieseier11Department of Neurology, Heinrich-Heine-University, D&uuml;sseldorf, Germany; 2Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden; 3Department of Neurology, Dallas Veterans Affairs Medical Center, TX, USA; 4Department of Neurology, University of Texas Southwestern Medical Center at Dallas, TX, USAAbstract: This review summarizes Phase III clinical trial data available for fingolimod. The main purpose is to evaluate the benefit-risk profile of fingolimod, the first oral compound available for treatment of multiple sclerosis (MS) and just recently approved by the European authorities. The authors place this evaluation in the context of the known safety and efficacy profile of established compounds for therapy of MS to outline the current and future potential of fingolimod. The authors conclude that only long-term safety data from post-marketing surveillance plans, together with additional head-to-head studies, would allow evidence-based treatment decisions. Furthermore, risk-profile analyses including patient history, exposure data to certain pathogens, and genetic analyses may potentially help to choose the right drug for individual patients in the future. Until these approaches toward an individualized medicine have been validated, treatment decisions for one or the other compound will have to be based partly on class IV evidence. Therefore, a close dialog with the well-informed patient, secured by effective risk mitigation plans, is required to choose the compound.Keywords: FTY720, oral drug, spingosine 1-phosphate receptorWarnke CSt&uuml;ve OHartung HPFogdell-Hahn AKieseier BDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2011, Iss Issue 1, Pp 519-527 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Warnke C St&uuml;ve O Hartung HP Fogdell-Hahn A Kieseier B Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis
description	Clemens Warnke1,2, Olaf St&uuml;ve3,4, Hans-Peter Hartung1, Anna Fogdell-Hahn2, Bernd C Kieseier11Department of Neurology, Heinrich-Heine-University, D&uuml;sseldorf, Germany; 2Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden; 3Department of Neurology, Dallas Veterans Affairs Medical Center, TX, USA; 4Department of Neurology, University of Texas Southwestern Medical Center at Dallas, TX, USAAbstract: This review summarizes Phase III clinical trial data available for fingolimod. The main purpose is to evaluate the benefit-risk profile of fingolimod, the first oral compound available for treatment of multiple sclerosis (MS) and just recently approved by the European authorities. The authors place this evaluation in the context of the known safety and efficacy profile of established compounds for therapy of MS to outline the current and future potential of fingolimod. The authors conclude that only long-term safety data from post-marketing surveillance plans, together with additional head-to-head studies, would allow evidence-based treatment decisions. Furthermore, risk-profile analyses including patient history, exposure data to certain pathogens, and genetic analyses may potentially help to choose the right drug for individual patients in the future. Until these approaches toward an individualized medicine have been validated, treatment decisions for one or the other compound will have to be based partly on class IV evidence. Therefore, a close dialog with the well-informed patient, secured by effective risk mitigation plans, is required to choose the compound.Keywords: FTY720, oral drug, spingosine 1-phosphate receptor
format	article
author	Warnke C St&uuml;ve O Hartung HP Fogdell-Hahn A Kieseier B
author_facet	Warnke C St&uuml;ve O Hartung HP Fogdell-Hahn A Kieseier B
author_sort	Warnke C
title	Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis
title_short	Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis
title_full	Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis
title_fullStr	Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis
title_full_unstemmed	Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis
title_sort	critical appraisal of the role of fingolimod in the treatment of multiple sclerosis
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/1f40c5bda7594a358c550787481ca194
work_keys_str_mv	AT warnkec criticalappraisaloftheroleoffingolimodinthetreatmentofmultiplesclerosis AT stampuumlveo criticalappraisaloftheroleoffingolimodinthetreatmentofmultiplesclerosis AT hartunghp criticalappraisaloftheroleoffingolimodinthetreatmentofmultiplesclerosis AT fogdellhahna criticalappraisaloftheroleoffingolimodinthetreatmentofmultiplesclerosis AT kieseierb criticalappraisaloftheroleoffingolimodinthetreatmentofmultiplesclerosis
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Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis

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