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J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1183-9. doi: 10.1136/jnnp-2013-306222. Epub 2013 Nov 11.

Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT.

Author information

1
University of Rennes, Rennes, France.
2
University of Basel and University Hospital, Basel, Switzerland.
3
Department of Clinical Neuroimmunology, Hospital Vall d'Hebron, Barcelona, Spain.
4
VU University Medical Center, Amsterdam, The Netherlands.
5
Ottawa Hospital Research Institute, Ottawa, Canada.
6
Heinrich-Heine University, Düsseldorf, Germany.
7
National Hospital for Neurology and Neurosurgery, London, UK.
8
MS MRI Centre-Free University Hospital, Amsterdam, The Netherlands.
9
PAREXEL International GmbH, Berlin, Germany.
10
Bayer Pharma AG, Berlin, Germany.
11
Bayer Pharma AG, Berlin, Germany Department of Neurology, University Hospital of Bonn, Bonn, Germany.
12
Heinrich-Heine University, Düsseldorf, Germany Bayer Pharma AG, Berlin, Germany.
13
Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey, USA.

Abstract

OBJECTIVE:

To examine the long-term impact of early treatment initiation of interferon beta-1b (IFNB1b, Betaferon/Betaseron) in patients with a first event suggestive of multiple sclerosis (MS).

METHODS:

In the original placebo-controlled phase of BENEFIT, patients were randomised to IFNB1b 250 μg or placebo subcutaneously every other day. After 2 years or diagnosis of clinically definite MS (CDMS), all patients were offered open-label IFNB1b treatment for a maximum duration of 5 years. Thereafter, patients were enrolled in an observational extension study for up to 8.7 years.

RESULTS:

Of the initial 468 patients, 284 (60.7%; IFNB1b: 178 (61.0% of the original arm), placebo: 106 (60.2% of original arm)) were enrolled in the extension study. 94.2% of patients were receiving IFNB1b. Patients originally randomised to IFNB1b had a reduced risk of developing CDMS by 32.2% over the 8-year observation period (HR 0.678; 95% CI 0.525 to 0.875; p=0.0030), a longer median time to CDMS by 1345 days (95% CI 389 to 2301), and a lower annualised relapse rate (0.196 (95% CI 0.176 to 0.218) versus 0.255 (95% CI 0.226 to 0.287), p=0.0012), with differences mainly emerging in the first year of the study. Cognitive outcomes remained higher in the early treated patients. EDSS remained low over time with a median of 1.5 in both arms.

CONCLUSIONS:

These 8-year results provide further evidence supporting early initiation of treatment with IFNB1b in patients with a first event suggestive of MS.

KEYWORDS:

INTERFERON; INTERVENTIONAL; MULTIPLE SCLEROSIS; RANDOMISED TRIALS

PMID:
24218527
PMCID:
PMC4215285
DOI:
10.1136/jnnp-2013-306222
[Indexed for MEDLINE]
Free PMC Article
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