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Mult Scler. 2016 Apr;22(4):533-43. doi: 10.1177/1352458515594440. Epub 2015 Sep 11.

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

Author information

1
Neurology, Departments of Medicine, Clinical Research and Biomedicine, University Hospital Basel/Blizard Institute, Queen Mary University of London, Barts, UK/London School of Medicine and Dentistry, UK University Hospital Basel, Switzerland.
2
Neurology, Departments of Medicine, Clinical Research and Biomedicine, University Hospital Basel.
3
Blizard Institute, Queen Mary University of London, Barts, UK/London School of Medicine and Dentistry, UK. Neurocentre of Southern Switzerland, Ospedale Civico, Lugano, Switzerland.
4
Department of Medicine, Neurology, Kantonsspital Baselland Bruderholz, Switzerland.
5
Department NEUROFARBA, Section Neurosciences, University of Florence, Italy.
6
Department of Neurology, Klinik Hennigsdorf, Germany.
7
Department of Neurology, University of Würzburg, Germany.
8
Department of Neurology, Klinikum Augsburg, Germany.
9
Unité Institut national de la santé et de la recherche médicale (INSERM) 563, Centre hospitalier universitaire Purpan, Toulouse, France.
10
Department of Neurology, and INSERM-CHU CIC-P 0005, Centre hospitalier universitaire de Bordeaux, France.
11
Centre de coordination EDMUS pour la sclérose en plaques, Hôpital Neurologique Pierre-Wertheimer, Lyon, France.
12
Department of Neurology, Centre hospitalier universitaire Pontchaillou, Rennes, France.
13
Department of Neurology, Central Hospital, Helsinki University, Finland.
14
Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden.
15
Department of Neurological Sciences, University of Rome La Sapienza, Italy.
16
Department of Neurology, National MS Center, Melsbroek, Belgium/Vrije Universiteit Brussel, Belgium.
17
Saint Vincent's University Hospital, University College Dublin, Ireland.
18
Departments of Neurology, University Medical Center Groningen, Netherlands.
19
Department of Neurology, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.
20
Institute of Clinical Neuroimmunology, Ludwig Maximilians University, Munich, Germany.
21
MS Center of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain.
22
MS Center Amsterdam, Vrije University Medical Center, Netherlands.
23
Department of Neurology, Hôpital Tenon, Paris, France.
24
PAREXEL International GmbH, Berlin, Germany.
25
University Clinic of Neurology, Medical University of Vienna, Austria.
26
University Hospital of Schleswig-Holstein, Lübeck, Germany.
27
Neurology, Departments of Medicine, Clinical Research and Biomedicine, University Hospital Basel ludwig.kappos@usb.ch.

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.

KEYWORDS:

Disability; interferon beta; long-term outcome; magnetic resonance imaging; multiple sclerosis; neutralizing antibodies; prognosis; randomized controlled trial; secondary progressive multiple sclerosis

PMID:
26362898
DOI:
10.1177/1352458515594440
[Indexed for MEDLINE]

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