Author Topic: (Abst.) 10-yr. follow up of European multicenter trial of Betaseron in SPMS  (Read 110 times)

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Offline agate

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From PubMed, September 13, 2015:

Mult Scler. 2015 Sep 11. pii: 1352458515594440.

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

Kuhle J1, Hardmeier M2, Disanto G3, Gugleta K2, Ecsedi M2, Lienert C4, Amato MP5, Baum K6, Buttmann M7, Bayas A8, Brassat D9, Brochet B10, Confavreux C11, Edan G12, Färkkilä M13, Fredrikson S14, Frontoni M15, D'Hooghe M16, Hutchinson M17, De Keyser J18, Kieseier BC19, Kümpfel T20, Rio J21, Polman C22, Roullet E23, Stolz C24, Vass K25, Wandinger KP26, Kappos L27; European Long-term Follow-up Study Group in Interferon β-1b in Secondary-progressive Multiple Sclerosis.

Author information:  [The authors are from the UK, Germany, France, Italy, Switzerland, Spain, Austria, and the Netherlands]


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).


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.


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 R2: 0.47). The ability to predict changes in EDSS 10 years after the RCT was limited (R2: 0.12). Magnetic resonance imaging (MRI) measures remained in the predictive models, but explained < 5% of the variability.


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.

The abstract can be seen here.
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SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.