Sistema de Salut de Catalunya
Institut Català de la Salut
[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
Vall d'Hebron Barcelona Hospital Campus
2024-01-11T07:17:47Z
2024-01-11T07:17:47Z
2023-12
Cladribine tablets; Multiple sclerosis; Quality of life
Pastilles de cladribina; Esclerosi múltiple; Qualitat de vida
Pastillas de cladribina; Esclerosis múltiple; Calidad de vida
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.
This work was supported by Merck (CrossRef Funder ID: 10.13039/100009945).
Article
Published version
English
Esclerosi múltiple - Tractament; Qualitat de vida; Medicaments antineoplàstics - Ús terapèutic; DISEASES::Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis; Other subheadings::Other subheadings::Other subheadings::/drug therapy; PUBLIC HEALTH::Environmental Health::Science::Environmental Quality::Quality of Life; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents; Other subheadings::Other subheadings::/therapeutic use; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; SALUD PÚBLICA::salud ambiental::ciencia::calidad ambiental::calidad de vida; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos; Otros calificadores::Otros calificadores::/uso terapéutico
SAGE Publications
Multiple Sclerosis Journal;29(14)
https://doi.org/10.1177/13524585231205962
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
Articles científics - CEMCAT [136]
Articles científics - HVH [3396]
