A 10-year follow-up of the European multicenter trial of interferon β-1b in secondary-progressivemultiple sclerosis.Mult Scler. 2015 Sep 11. pii: 1352458515594440. [Epub ahead of print]
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.
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 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.
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.
Secondary progressive MS has uniformly so far, failed to respond to peripheral immunomodulation. Despite some early optimism that beta interferon was useful in SPMS, the realisation that it was affecting the relapses in relapsing SPMS shows that we need something else. ProfG has presented info on the blog that interferon treatment may influence disease as people treated with beta interferon died later than people on placebo in trials. This study is long term follow-up of people with SPMS taking beta interferon and re-affirms that it was not doing much.