A 10-year follow-up of the European multicenter trial of interferon beta-1b in secondary-progressive multiple sclerosis

Autor: Antonios Bayas, Kp Wandinger, Sten Fredrikson, Cyrille B. Confavreux, B. C. Kieseier, Ludwig Kappos, Mathias Buttmann, Jordi Río, J. De Keyser, David Brassat, Jens Kuhle, Giulio Disanto, Chris H. Polman, M Ecsedi, M. Frontoni, M Hardmeier, Michael Hutchinson, Markus Färkkilä, M. P. Amato, K Baum, T. Kümpfel, Claude Stolz, K Gugleta, M D’hooghe, E Roullet, Bruno Brochet, Karl Vass, Carmen Lienert, Gilles Edan
Přispěvatelé: University Hospital Basel [Basel], Queen Mary University of London (QMUL), Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Kantonsspital Baselland [Bruderholz] (KSBL), NASA Goddard Space Flight Center (GSFC), Klinik Hennigsdorf, Julius-Maximilians-Universität Würzburg (JMU), Klinikum Augsburg, Service de neurologie [Bordeaux], CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Université de Bordeaux (UB), Service de Neurologie [Hospices civils de Lyon - Hôpital Pierre Wertheimer], Hospices Civils de Lyon (HCL)-Hôpital neurologique et neurochirurgical Pierre Wertheimer [CHU - HCL], Hospices Civils de Lyon (HCL), Vision, Action et Gestion d'informations en Santé (VisAGeS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Inria Rennes – Bretagne Atlantique, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-SIGNAUX ET IMAGES NUMÉRIQUES, ROBOTIQUE (IRISA-D5), Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Université de Rennes (UR)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Institut National de Recherche en Informatique et en Automatique (Inria)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université de Bretagne Sud (UBS)-École normale supérieure - Rennes (ENS Rennes)-Télécom Bretagne-CentraleSupélec-Centre National de la Recherche Scientifique (CNRS), Service de Neurologie [Rennes] = Neurology [Rennes], CHU Pontchaillou [Rennes], Helsingin yliopisto = Helsingfors universitet = University of Helsinki, Department of Clinical Neurosciences, Neurology Division, Karolinska Institutet, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome] (UNIROMA), Vrije Universiteit Brussel (VUB), Department of Microbiology and Immunology, Drexel University College of Medicine, University Medical Center Groningen [Groningen] (UMCG), Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Ludwig-Maximilians-Universität München (LMU), Institut du Fer à Moulin, Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Vrije Universiteit Amsterdam [Amsterdam] (VU), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), PAREXEL International [Berlin], Medizinische Universität Wien = Medical University of Vienna, University Hospital of Schleswig-Holstein, Department of Neurology [Suisse], Julius-Maximilians-Universität Würzburg [Wurtzbourg, Allemagne] (JMU), CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de Recherche en Informatique et en Automatique (Inria)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-CentraleSupélec-Télécom Bretagne-Université de Rennes 1 (UR1), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA)-Institut de Recherche en Informatique et Systèmes Aléatoires (IRISA), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École normale supérieure - Rennes (ENS Rennes)-Université de Bretagne Sud (UBS)-Centre National de la Recherche Scientifique (CNRS)-Institut National des Sciences Appliquées - Rennes (INSA Rennes), Institut National des Sciences Appliquées (INSA)-Université de Rennes (UNIV-RENNES)-Institut National des Sciences Appliquées (INSA), University of Helsinki, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, Neuroprotection & Neuromodulation, Clinical sciences, Neurologian yksikkö, Department of Neurosciences, Clinicum
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Male
0301 basic medicine
Time Factors
Multivariate analysis
[SDV]Life Sciences [q-bio]
Disability
interferon beta
long-term outcome
magnetic resonance imaging
multiple sclerosis
neutralizing antibodies
prognosis
randomized controlled trial
secondary progressive multiple sclerosis
THERAPY
3124 Neurology and psychiatry
MESH: Magnetic Resonance Imaging
MESH: Linear Models
law.invention
Disability Evaluation
0302 clinical medicine
Randomized controlled trial
law
MESH: Double-Blind Method
10. No inequality
PREDICTORS
MESH: Treatment Outcome
MESH: Immunologic Factors
MESH: Disability Evaluation
MESH: Follow-Up Studies
Multiple Sclerosis
Chronic Progressive
3. Good health
Europe
Treatment Outcome
Neurology
Cohort
Disease Progression
SURVIVAL
Female
MESH: Disease Progression
Interferon beta-1b
Adult
medicine.medical_specialty
PHASE
MESH: Interferon beta-1b
Placebo
MESH: Multivariate Analysis
03 medical and health sciences
Double-Blind Method
Multicenter trial
Internal medicine
medicine
Humans
Immunologic Factors
COHORT
MESH: Multiple Sclerosis
Chronic Progressive
MESH: Humans
Expanded Disability Status Scale
business.industry
Multiple sclerosis
MESH: Time Factors
MESH: Adult
NATURAL-HISTORY
MS
medicine.disease
MESH: Male
030104 developmental biology
MOTOR EVOKED-POTENTIALS
Multivariate Analysis
Linear Models
Physical therapy
MESH: Europe
Neurology (clinical)
business
MESH: Female
030217 neurology & neurosurgery
Follow-Up Studies
LONG-TERM DISABILITY
Zdroj: Kuhle, J, Hardmeier, M, Disanto, G, Gugleta, K, Ecsedi, M, Lienert, C, Amato, M P, Baum, K, Buttmann, M, Bayas, A, Brassat, D, Brochet, B, Confavreux, C, Edan, G, Färkkilä, M, Fredrikson, S, Frontoni, M, D'Hooghe, M, Hutchinson, M, De Keyser, J, Kieseier, B C, Kümpfel, T, Rio, J, Polman, C, Roullet, E, Stolz, C, Vass, K, Wandinger, K P & Kappos, L 2016, ' A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis ', Multiple Sclerosis, vol. 22, no. 4, pp. 533-543 . https://doi.org/10.1177/1352458515594440
Multiple Sclerosis Journal
Multiple Sclerosis Journal, 2015, 22 (4), pp.533-43. ⟨10.1177/1352458515594440⟩
Multiple sclerosis (Houndmills Basingstoke England)
Multiple sclerosis journal, 22(4), 533-543. SAGE Publications Inc.
Multiple Sclerosis Journal, SAGE Publications, 2015, 22 (4), pp.533-43. ⟨10.1177/1352458515594440⟩
Multiple Sclerosis, 22(4), 533-543. SAGE Publications Ltd
ISSN: 1477-0970
1352-4585
DOI: 10.1177/1352458515594440
Popis: Objectives: To explore long-term effects of treatment and prognostic relevance of variables assessed at baseline and during the European secondary progressive multiple sclerosis (SPMS) trial of interferon beta 1b (IFNB-1b). Methods: We assessed 362 patients (60% female; median age 41 years; Expanded Disability Status Scale (EDSS): 5.5; 51% randomized to IFNB-1b) for their EDSS and treatment history after 10 years. Non-parametric analysis of covariance (ANCOVA) and multivariate linear regression models were applied. Results: Median EDSS was 6.0 at the end of the randomized controlled trial (RCT), in the IFNB-1b and placebo groups, and 7.0 in long-term follow-up patients (those receiving IFNB-1b in the RCT were 6.5 and those receiving placebo in the RCT were 7.0; p = 0.086). 24 patients (6.6%) were deceased. The EDSS at baseline and the EDSS change during the RCT were the most important predictors of the EDSS 10 years later (partial R2: 0.47). The ability to predict changes in EDSS 10 years after the RCT was limited ( R2: 0.12). Magnetic resonance imaging (MRI) measures remained in the predictive models, but explained < 5% of the variability. Conclusions: The results from this analysis did not provide convincing evidence to support a favorable long-term outcome in those patients allocated IFNB-1b during the RCT, in our SPMS cohort. The progressive stage of the disease remains largely unpredictable by clinical and conventional MRI measures, so better prognostic markers are needed.
Databáze: OpenAIRE
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