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J Neurol Neurosurg Psychiatry. 2016 May;87(5):468-75. doi: 10.1136/jnnp-2015-310597. Epub 2015 Jun 25.

Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study.

Author information

1
Neurological Institute, Cleveland Clinic, Cleveland, Ohio, USA.
2
Center for Neurological Disorders and the Regional MS Center at WFHC, Milwaukee, Wisconsin, USA.
3
Image Analysis Centre, VU University Medical Centre, Amsterdam, The Netherlands.
4
Department of Neurology, Vita-Salute San Raffaele University, Milan, Italy.
5
Department of Neurology, Heinrich Heine University, Düsseldorf, Germany.
6
Department of Neurology-Neuroimmunology, Vall d'Hebron University Hospital, Barcelona, Spain.
7
Department of Neurology and CRMBM CNRS6612, Aix Marseille Université, CHU La Timone, Marseille, France.
8
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
9
Biogen, 14 Cambridge Center, Cambridge, Massachusetts, USA.
10
Novartis Pharma AG, Basel, Switzerland.
11
Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital, Basel, Switzerland.

Abstract

OBJECTIVE:

The 12-month (M), phase 3, double-blind, randomised TRANSFORMS study demonstrated significant benefits of fingolimod 0.5 or 1.25 mg over interferon β-1a (IFNβ-1a) in patients with relapsing-remitting multiple sclerosis. We report the results of long-term (up to 4.5 years) extension of TRANSFORMS.

METHODS:

Patients randomised to fingolimod (0.5/1.25 mg) in the core phase continued the same dose (continuous-fingolimod) in the extension, whereas those on IFNβ-1a were re-randomised (1:1) to fingolimod (IFN-switch; IFN: 0.5/1.25 mg). Outcomes included annualised relapse rate (ARR), confirmed disability progression and MRI measures. Results are presented here for the continuous-fingolimod 0.5 mg and pooled IFN-switch groups.

RESULTS:

Of the 1027 patients who entered the extension, 772 (75.2%) completed the study. From baseline to the end of the study (EOS), ARR in patients on continuous-fingolimod 0.5 mg was significantly lower than in the IFN-switch group (M0-EOS: 0.17 vs 0.27). After switching to fingolimod (M0-12 vs M13-EOS), patients initially treated with IFN had a 50% reduction in ARR (0.40 vs 0.20), reduced MRI activity and a lower rate of brain volume loss. In a post hoc analysis, the proportion of IFN-switch patients with no evidence of disease activity increased by approximately 50% in the first year after switching to fingolimod treatment (44.3% to 66.0%). The safety profile was consistent with that observed in the core phase.

CONCLUSIONS:

These results support a continued effect of long-term fingolimod therapy in maintaining a low rate of disease activity and sustained improved efficacy after switching from IFNβ-1a to fingolimod.

CLINICAL TRIAL REGISTRATION NO:

NCT00340834.

PMID:
26111826
PMCID:
PMC4853559
DOI:
10.1136/jnnp-2015-310597
[Indexed for MEDLINE]
Free PMC Article

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