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

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.

• Authors: J Kuhle, M Hardmeier, G Disanto, K Gugleta, M Ecsedi, C Lienert, M P Amato, K Baum, M Buttmann, A Bayas, D Brassat, B Brochet, C Confavreux, G Edan, M Färkkilä, S Fredrikson, M Frontoni, M D'Hooghe, M Hutchinson, J De Keyser, B C Kieseier, T Kümpfel, J Rio, C Polman, E Roullet, C Stolz, K Vass, K P Wandinger, L Kappos, European Long-term Follow-up Study Group in Interferon β-1b in Secondary-progressive Multiple Sclerosis
• Journal: Multiple sclerosis (Houndmills, Basingstoke, England) (Mult Scler) Vol. 22 Issue 4 Pg. 533-43 (Apr 2016) ISSN: 1477-0970 [Electronic] England
• PMID: 26362898 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s), 2015.

Chemical References

• Immunologic Factors
• Interferon beta-1b

Topics

• Adult
• Disability Evaluation
• Disease Progression
• Double-Blind Method
• Europe
• Female
• Follow-Up Studies
• Humans
• Immunologic Factors (adverse effects, therapeutic use)
• Interferon beta-1b (adverse effects, therapeutic use)
• Linear Models
• Magnetic Resonance Imaging
• Male
• Multiple Sclerosis, Chronic Progressive (diagnosis, drug therapy, mortality)
• Multivariate Analysis
• Time Factors
• Treatment Outcome