Sistema de Salut de Catalunya
Institut Català de la Salut
[Kappos L] Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Head-Organs, Spine and Neuromedicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland. [Edan G] CHU Hôpital Pontchaillou, Rennes, France. [Freedman MS] Department of Medicine, University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, Canada. [Hartung HP] Department of Neurology, Medical Faculty, Heinrich-Heine Universität, Düsseldorf, Germany. Brain and Mind Center, University of Sydney, Sydney, Australia. Department of Neurology, Palacky University in Olomouc, Olomouc, Czech Republic. Department of Neurology, Medical University of Vienna, Vienna, Austria. [Montalbán X] Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Barkhof F] Amsterdam UMC, Location Vrije Universiteit, Amsterdam, The Netherlands. Queen Square Institute of Neurology and Centre for Medical Image Computing, UCL, London, UK
Vall d'Hebron Barcelona Hospital Campus
2024-07-18T09:19:46Z
2024-07-18T09:19:46Z
2024-07
Immunotherapy; Interferon beta-1b; Multiple sclerosis
Immunoteràpia; interferó beta-1b; Esclerosi múltiple
Inmunoterapia; Interferón beta-1b; Esclerosis múltiple
Multiple sclerosis (MS) treatment intervention with immunomodulating therapy at early disease stage improves short term clinical outcomes. The objective of this study is to describe the long-term outcomes and healthcare utilization of patients with clinically isolated syndrome (CIS) included in the Betaferon®/Betaseron® in Newly Emerging MS for Initial Treatment (BENEFIT) randomized, parallel group trial. In BENEFIT patients were assigned to “early” IFNB-1b treatment or placebo (“delayed” treatment). After 2 years or conversion to clinically definite multiple sclerosis (CDMS), all patients were offered IFNB-1b and were reassessed 15 years later. Of 468 patients, 261 (55.8%) were enrolled into BENEFIT 15 (161 [55.1%] from the early, 100 [56.8%] from the delayed treatment arm). In the full BENEFIT analysis set, risk of conversion to CDMS remained lower in the early treatment group ( – 30.5%; hazard ratio 0.695 [95% CI, 0.547–0.883]; p = 0.0029) with a 15.7% lower risk of relapse than in the delayed treatment group (p = 0.1008). Overall, 25 patients (9.6%; 9.9% early, 9.0% delayed) converted to secondary progressive multiple sclerosis. Disability remained low and stable with no significant difference between groups in Expanded Disability Status Scale score or MRI metrics. Paced Auditory Serial Addition Task-3 scores were better in the early treatment group (p = 0.0036 for treatment effect over 15 years). 66.3% of patients were still employed at Year 15 versus 74.7% at baseline. In conclusion, results 15 years from initial randomization support long-term benefits of early treatment with IFNB-1b.
Open access funding provided by University of Basel. This study was funded by Bayer AG.
Article
Published version
English
Avaluació de resultats (Assistència sanitària); Esclerosi múltiple - Tractament; Medicaments immunosupressors - 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; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Immunosuppressive Agents; Other subheadings::Other subheadings::/therapeutic use; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::factores inmunitarios::inmunosupresores; Otros calificadores::Otros calificadores::/uso terapéutico; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
Springer
Journal of Neurology;271
https://doi.org/10.1007/s00415-024-12417-x
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3440]
