Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS

Brain volume; Multiple sclerosis; Ozanimod

Detalhes bibliográficos
Autores: DeLuca, John, Schippling, Sven, Montalban, Xavier, Kappos, Ludwig, Cree, Bruce, Comi, Giancarlo
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Recursos:Departament de Salut de la Generalitat de Catalunya (DS)
Repositorio:Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:oai:scientiasalut.gencat.cat:11351/7759
Acesso em linha:https://hdl.handle.net/11351/7759
Access Level:acceso abierto
Palavra-chave:Esclerosi múltiple - Tractament
Tests neuropsicològics
DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Relapsing-Remitting
Other subheadings::Other subheadings::Other subheadings::/drug therapy
PSYCHIATRY AND PSYCHOLOGY::Behavioral Disciplines and Activities::Psychological Tests::Neuropsychological Tests
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple recurrente-remitente
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
PSIQUIATRÍA Y PSICOLOGÍA::disciplinas y actividades conductuales::pruebas psicológicas::pruebas neuropsicológicas
id ES_f7ae744940e7f04f172b41ea4d4fa699
oai_identifier_str oai:scientiasalut.gencat.cat:11351/7759
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
title Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
spellingShingle Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
DeLuca, John
Esclerosi múltiple - Tractament
Tests neuropsicològics
DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Relapsing-Remitting
Other subheadings::Other subheadings::Other subheadings::/drug therapy
PSYCHIATRY AND PSYCHOLOGY::Behavioral Disciplines and Activities::Psychological Tests::Neuropsychological Tests
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple recurrente-remitente
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
PSIQUIATRÍA Y PSICOLOGÍA::disciplinas y actividades conductuales::pruebas psicológicas::pruebas neuropsicológicas
title_short Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
title_full Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
title_fullStr Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
title_full_unstemmed Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
title_sort Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
dc.creator.none.fl_str_mv DeLuca, John
Schippling, Sven
Montalban, Xavier
Kappos, Ludwig
Cree, Bruce
Comi, Giancarlo
author DeLuca, John
author_facet DeLuca, John
Schippling, Sven
Montalban, Xavier
Kappos, Ludwig
Cree, Bruce
Comi, Giancarlo
author_role author
author2 Schippling, Sven
Montalban, Xavier
Kappos, Ludwig
Cree, Bruce
Comi, Giancarlo
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[DeLuca J] Kessler Foundation, NJ 07052, USA. Departments of Physical Medicine and Rehabilitation, and Neurology, Rutgers - New Jersey Medical School, Newark 07103, NJ, USA. [Schippling S] Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital and University of Zürich and Neuroscience Center Zürich, University of Zürich, 8091 Zurich, Switzerland. Federal Institute of Technology (ETH) Zürich, 8092 Zürich, Switzerland. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d'Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Kappos L] Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, CH-4031 Basel, Switzerland. [Cree BAC] Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA 94158 USA. [Comi G] Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, 20132 Milan, Italy
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Esclerosi múltiple - Tractament
Tests neuropsicològics
DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Relapsing-Remitting
Other subheadings::Other subheadings::Other subheadings::/drug therapy
PSYCHIATRY AND PSYCHOLOGY::Behavioral Disciplines and Activities::Psychological Tests::Neuropsychological Tests
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple recurrente-remitente
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
PSIQUIATRÍA Y PSICOLOGÍA::disciplinas y actividades conductuales::pruebas psicológicas::pruebas neuropsicológicas
topic Esclerosi múltiple - Tractament
Tests neuropsicològics
DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Relapsing-Remitting
Other subheadings::Other subheadings::Other subheadings::/drug therapy
PSYCHIATRY AND PSYCHOLOGY::Behavioral Disciplines and Activities::Psychological Tests::Neuropsychological Tests
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple recurrente-remitente
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
PSIQUIATRÍA Y PSICOLOGÍA::disciplinas y actividades conductuales::pruebas psicológicas::pruebas neuropsicológicas
description Brain volume; Multiple sclerosis; Ozanimod
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/7759
url https://hdl.handle.net/11351/7759
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Multiple Sclerosis and Related Disorders;48
https://doi.org/10.1016/j.msard.2020.102673
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv Scientia
reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869424905327476736
spelling Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MSDeLuca, JohnSchippling, SvenMontalban, XavierKappos, LudwigCree, BruceComi, GiancarloEsclerosi múltiple - TractamentTests neuropsicològicsDISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Relapsing-RemittingOther subheadings::Other subheadings::Other subheadings::/drug therapyPSYCHIATRY AND PSYCHOLOGY::Behavioral Disciplines and Activities::Psychological Tests::Neuropsychological TestsENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple recurrente-remitenteOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaPSIQUIATRÍA Y PSICOLOGÍA::disciplinas y actividades conductuales::pruebas psicológicas::pruebas neuropsicológicasBrain volume; Multiple sclerosis; OzanimodVolumen cerebral; Esclerosis múltiple; OzanimodVolum cerebral; Esclerosi múltiple; OzanimodBackground Cognitive dysfunction, including slowed cognitive processing speed (CPS), is one of the most disabling symptoms of multiple sclerosis (MS). The Symbol Digit Modalities Test (SDMT) is a preferred measure of CPS for MS trials and routine screening. Based on encouraging SDMT results in the phase 3 SUNBEAM trial, these post hoc, exploratory analyses were conducted to further compare effects of the sphingosine 1-phosphate receptor modulator ozanimod versus intramuscular interferon β-1a on CPS in participants with relapsing multiple sclerosis (RMS). Methods In the phase 3, double-blind, double-dummy, SUNBEAM study, adults (aged 18‒55 years) with RMS (N=1,346) were randomized to once-daily oral ozanimod 0.92 or 0.46 mg, or weekly intramuscular interferon β-1a 30 µg. The study continued until the last participant was treated for 12 months. CPS was measured as part of a secondary endpoint using the SDMT. Exploratory, post hoc analyses evaluated SDMT change and percentages of participants with clinically meaningful (≥4-point) SDMT improvement or worsening at months 6 and 12, and relationship between SDMT and brain volume on magnetic resonance imaging. Results Ozanimod improved SDMT scores compared with interferon β-1a at months 6 and 12. At month 12, least squares mean difference in SDMT z-scores for ozanimod 0.92 mg versus interferon β-1a was 0.102 (95% CI, 0.031‒0.174, nominal p = 0.0051; standardized mean difference = 0.1376). A greater percentage of ozanimod 0.92 mg‒treated participants had clinically meaningful improvements in SDMT scores versus interferon β-1a at month 6 (30.0% versus 22.2%) and month 12 (35.6% versus 27.9%). Of those with SDMT improvement at month 6, 66.4% of those treated with ozanimod 0.92 mg and 55.9% of those treated with interferon β-1a had sustained improvement at month 12. Brain volume loss was similar for those with SDMT improvement versus worsening at month 12. Conclusions In these exploratory analyses, ozanimod had modestly beneficial effects on CPS in RMS participants. The effects of ozanimod on SDMT are being further evaluated in an ongoing 3-year clinical trial. SUNBEAM is registered on clinicaltrials.gov (NCT02294058) and the European Clinical Trials Database (EudraCT 2014‐002320‐27).SUNBEAM was sponsored by Celgene Corporation. The sponsor was involved in data analysis and interpretation, and manuscript preparation, review, and approval. All authors vouch for data accuracy, reviewed all drafts, and approved the final manuscript.ElsevierInstitut Català de la Salut[DeLuca J] Kessler Foundation, NJ 07052, USA. Departments of Physical Medicine and Rehabilitation, and Neurology, Rutgers - New Jersey Medical School, Newark 07103, NJ, USA. [Schippling S] Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital and University of Zürich and Neuroscience Center Zürich, University of Zürich, 8091 Zurich, Switzerland. Federal Institute of Technology (ETH) Zürich, 8092 Zürich, Switzerland. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d'Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Kappos L] Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, CH-4031 Basel, Switzerland. [Cree BAC] Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA 94158 USA. [Comi G] Department of Neurology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, 20132 Milan, ItalyVall d'Hebron Barcelona Hospital Campus2022202220202021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/7759Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésMultiple Sclerosis and Related Disorders;48https://doi.org/10.1016/j.msard.2020.102673Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/77592026-06-12T09:38:37Z
score 15,812455

Registos relacionados