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

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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 , Kuempfel , T , Rio , J , Polman , C , Roullet , E , Stolz , C , Vass , K , Wandinger , K P , Kappos , L & European Long Term Follow Up Study 2016 , ' A 10-year follow-up of the European multicenter trial of interferon beta-1b in secondary-progressive multiple sclerosis ' Multiple Sclerosis Journal , vol. 22 , no. 4 , pp. 533-543 . DOI: 10.1177/1352458515594440

Title: A 10-year follow-up of the European multicenter trial of interferon beta-1b in secondary-progressive multiple sclerosis
Author: 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, Markus; Fredrikson, S.; Frontoni, M.; D'Hooghe, M.; Hutchinson, M.; De Keyser, J.; Kieseier, B. C.; Kuempfel, T.; Rio, J.; Polman, C.; Roullet, E.; Stolz, C.; Vass, K.; Wandinger, K. P.; Kappos, L.; European Long Term Follow Up Study
Contributor: University of Helsinki, Neurologian yksikkö
Date: 2016-04
Language: eng
Number of pages: 11
Belongs to series: Multiple Sclerosis Journal
ISSN: 1352-4585
URI: http://hdl.handle.net/10138/161300
Abstract: 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 R-2: 0.47). The ability to predict changes in EDSS 10 years after the RCT was limited (R-2: 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.
Subject: Disability
interferon beta
long-term outcome
magnetic resonance imaging
multiple sclerosis
neutralizing antibodies
prognosis
randomized controlled trial
secondary progressive multiple sclerosis
MOTOR EVOKED-POTENTIALS
LONG-TERM DISABILITY
NATURAL-HISTORY
MS
THERAPY
COHORT
PREDICTORS
SURVIVAL
PHASE
3124 Neurology and psychiatry
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