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.

A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis / 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, Marco; 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.. - In: MULTIPLE SCLEROSIS. - ISSN 1352-4585. - 22:4(2016), pp. 533-543. [10.1177/1352458515594440]

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

FRONTONI, Marco;
2016

Abstract

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.
Disability; interferon beta; long-term outcome; magnetic resonance imaging; multiple sclerosis; neutralizing antibodies; prognosis; randomized controlled trial; secondary progressive multiple sclerosis
01 Pubblicazione su rivista::01a Articolo in rivista
A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressive multiple sclerosis / 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, Marco; 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.. - In: MULTIPLE SCLEROSIS. - ISSN 1352-4585. - 22:4(2016), pp. 533-543. [10.1177/1352458515594440]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/875327
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