A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis. (April 2016)

• Record Type: Journal Article
• Authors: Kuhle, J; Hardmeier, M; Disanto, G; Gugleta, K; Ecsedi, M; Lienert, C; Amato, MP; 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, BC; Kümpfel, T; Rio, J; Polman, C; Roullet, E; Stolz, C; Vass, K; Wandinger, KP; Kappos, L
• Is Part Of: Multiple sclerosis. Volume 22:Number 4(2016)
• Page Start: 533
• Page End: 543
• Publication Date: 2016-04
• Subjects: Disability -- interferon beta -- long-term outcome -- magnetic resonance imaging -- multiple sclerosis -- neutralizing antibodies -- prognosis -- randomized controlled trial -- secondary progressive multiple sclerosis; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458515594440
• Languages: English
• ISSNs: 1352-4585

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.