Abstract | OBJECTIVES: 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.
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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)
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Copyright | © The Author(s), 2015. |
Chemical References |
- Immunologic Factors
- Interferon beta-1b
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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
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