dc.contributor
Institut Català de la Salut
dc.contributor
[Brochet B] INSERM U 1215, University of Bordeaux, Bordeaux, France. [Alessandra Solari] Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy. [Jeannette Lechner-Scott] University of Newcastle, Newcastle, NSW, Australia/ Division of Neurology, John Hunter Hospital, Newcastle, NSW, Australia. [Fredrik Piehl] Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. [Dawn Langdon] Department of Psychology, Royal Holloway, University of London, Egham, UK. [Raymond Hupperts] Zuyderland Medisch Centrum Sittard, Maastricht University Medical Center, Maastricht, The Netherlands. [Xavier Montalban] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Brochet, Bruno
dc.contributor.author
Solari, Alessandra
dc.contributor.author
Lechner-Scott, Jeannette
dc.contributor.author
Piehl, Fredrik
dc.contributor.author
langdon, dawn
dc.contributor.author
Hupperts, Raymond
dc.contributor.author
Montalban, Xavier
dc.date.issued
2024-01-11T07:17:47Z
dc.date.issued
2024-01-11T07:17:47Z
dc.identifier
Brochet B, Solari A, Lechner-Scott J, Piehl F, Langdon D, Hupperts R, et al. Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study. Mult Scler. 2023 Dec;29(14):1808–18.
dc.identifier
https://hdl.handle.net/11351/10810
dc.identifier
10.1177/13524585231205962
dc.identifier
001106665100001
dc.description.abstract
Cladribine tablets; Multiple sclerosis; Quality of life
dc.description.abstract
Pastilles de cladribina; Esclerosi múltiple; Qualitat de vida
dc.description.abstract
Pastillas de cladribina; Esclerosis múltiple; Calidad de vida
dc.description.abstract
Background:
Multiple sclerosis (MS) negatively affects health-related quality of life (HRQoL).
Objective:
To evaluate HRQoL in people with highly active relapsing MS treated with cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years) in CLARIFY-MS.
Methods:
Changes in the MS quality of life (MSQoL)-54 scores were analysed using a repeated mixed-effects linear model. Subgroup analyses were performed for participants who were pretreatment-naïve and those pretreated with disease-modifying therapies (DMTs) before initiating CladT. Safety and tolerability of CladT were also assessed.
Results:
MSQoL-54 physical (mean change = 4.86; 95% confidence interval (CI) = 3.18, 6.53) and mental health (4.80; 95% CI = 3.13, 6.46) composite scores (primary endpoints) showed significant improvement at Month 24 versus Baseline (p < 0.0001). Changes in the MSQoL-54 scores were consistent across the pretreatment-naïve and DMT-pretreated subgroups. No new severe or opportunistic infections occurred. Most post-baseline lymphopenia events were Grade 1–2 in severity. Transient Grade-3 lymphopenia was observed in 19.7% (95/482) of participants. Grade-4 lymphopenia was not observed.
Conclusions:
CladT treatment significantly improved the mean MSQoL-54 physical and mental health composite scores over 2 years. CladT efficacy in HRQoL, relapse rates and Expanded Disability Status Scale scores demonstrates its multidimensional effects in MS treatment.
dc.description.abstract
This work was supported by Merck (CrossRef Funder ID: 10.13039/100009945).
dc.format
application/pdf
dc.publisher
SAGE Publications
dc.relation
Multiple Sclerosis Journal;29(14)
dc.relation
https://doi.org/10.1177/13524585231205962
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Esclerosi múltiple - Tractament
dc.subject
Qualitat de vida
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Medicaments antineoplàstics - Ús terapèutic
dc.subject
DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis
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Other subheadings::Other subheadings::Other subheadings::/drug therapy
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PUBLIC HEALTH::Environmental Health::Science::Environmental Quality::Quality of Life
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CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents
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Other subheadings::Other subheadings::/therapeutic use
dc.subject
ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple
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Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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SALUD PÚBLICA::salud ambiental::ciencia::calidad ambiental::calidad de vida
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COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos
dc.subject
Otros calificadores::Otros calificadores::/uso terapéutico
dc.title
Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
