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Integrated 2-Year Results

Frederik Barkhof, MD, PhD; Chris H. Polman, MD, PhD; Ernst-Wilhelm Radue, MD; Ludwig Kappos, MD; Mark S. Freedman, MD; Gilles Edan, MD; Hans-Peter Hartung, MD; David H. Miller, MD; Xavier Montalbán, MD; Peter Poppe, MD; Marlieke de Vos, MSc; Fatiha Lasri, MD; Lars Bauer, MD; Susanne Dahms, PhD; Klaus Wagner, MD; Christoph Pohl, MD; Rupert Sandbrink, MD, PhD

Arch Neurol. 2007;64(9):1292-1298.

Background  In the Betaseron/Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study, interferon beta-1b delayed conversion to multiple sclerosis in patients with a first clinical event and at least 2 clinically silent brain magnetic resonance imaging (MRI) lesions.

Objective  To examine detailed MRI findings from the first 2 years of this trial.

Design  Double-blind, placebo-controlled, randomized, parallel-group, multicenter, phase 3 study.

Setting  Ninety-eight centers worldwide.

Patients  A total of 404 individuals with a first demyelinating event suggestive of multiple sclerosis.

Interventions  Patients were randomized to receive interferon beta-1b, 250 µg subcutaneously every other day, or placebo. After 24 months of treatment or on conversion to clinically definite multiple sclerosis, open-label interferon beta-1b treatment was offered.

Main Outcome Measures  Reported MRI data from patients completing 2 years of follow-up.

Results  Data were analyzed from 248 patients taking interferon beta-1b and 156 taking placebo. Across 2 years the cumulative number of newly active lesions was lower in patients receiving interferon beta-1b vs placebo (median, 2.0 vs 5.0 [reduction of 60%]; P < .001). This corresponded to lower cumulative numbers of new T2 lesions (median, 1.0 vs 3.0 [reduction of 66%]; P < .001) and new gadolinium-enhancing lesions (median, 0.0 vs 1.0; P < .001) in patients receiving interferon beta-1b vs placebo. From screening to month 24, T2 lesion volume decreased and was more pronounced in patients receiving interferon beta-1b (P = .02).

Conclusions  Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group. This effect was maintained despite including patients who switched from placebo to interferon beta-1b in the active treatment group.

Trial Registration  clinicaltrials.gov Identifier: NCT00185211

Author Affiliations: Departments of Diagnostic Radiology (Drs Barkhof, Poppe, and Lasri and Ms de Vos) and Neurology (Dr Polman), Vrije Universiteit Medical Center, Amsterdam, the Netherlands; Department of Neurology and Neurosurgery, University Hospital Basel, Basel, Switzerland (Drs Radue and Kappos); Multiple Sclerosis Research Unit, The Ottawa Hospital, Ottawa, Ontario, Canada (Dr Freedman); Department of Neurology, Centre Hospitalier Universitaire, Rennes, France (Dr Edan); Department of Neurology, Heinrich-Heine-Universität, Düsseldorf, Germany (Dr Hartung); Institute of Neurology, University College London, London, England (Dr Miller); Unit of Clinical Neuroimmunology, Hospital Vall d'Hebron, Barcelona, Spain (Dr Montalbán); Bayer Schering Pharma AG, Berlin, Germany (Drs Bauer, Dahms, Wagner, Pohl, and Sandbrink); and Department of Neurology, University Hospital, Bonn, Germany (Dr Pohl).