Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Antiplatelets after intracerebral haemorrhage: treat the patient, not the brain imaging

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Functional-structural assessment of the optic pathways in patients with optic neuritis

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Antibodies to Epstein-Barr virus and neurotropic viruses in multiple sclerosis and optic neuritis

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Facing privacy in neuroimaging: removing facial features degrades performance of image analysis methods

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Sensitive Assessment of Acute Optic Neuritis by a New, Digital Flicker Test

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon β-1a

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Ludwig Kappos
  • Mark S Freedman
  • Chris H Polman
  • Gilles Edan
  • Hans-Peter Hartung
  • David H Miller
  • Xavier Montalbán
  • Frederik Barkhof
  • Ernst-Wilhelm Radü
  • Carola Metzig
  • Lars Bauer
  • Vivian Lanius
  • Rupert Sandbrink
  • Christoph Pohl
  • Jette Lautrup Battistini
  • BENEFIT Study Group
View graph of relations
BACKGROUND: The Betaferon/Betaseron in newly emerging multiple sclerosis for initial treatment (BENEFIT) trial investigated the effect of treatment with interferon beta-1b after a clinically isolated syndrome. The 5-year active treatment extension compares the effects of early and delayed treatment with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive interferon beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years after randomisation. Patients and study personnel remained unaware of initial treatment allocation throughout the study. Primary endpoints were time to CDMS, time to confirmed disability progression measured with the expanded disability status scale, and the functional assessment of multiple sclerosis trial outcomes index (FAMS-TOI) at 5 years. Analysis of the primary endpoints was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00185211. FINDINGS: 235 (80%) patients from the early treatment and 123 (70%) from the delayed treatment group completed the 5-year study. Early treatment reduced the risk of CDMS by 37% (hazard ratio [HR] 0.63, 95% CI 0.48-0.83; p=0.003) compared with delayed treatment. The risk for confirmed disability progression was not significantly lower in the early treatment group (0.76, 0.52-1.11; p=0.177). At 5 years, median FAMS-TOI scores were 125 in both groups. No significant differences in other disability related outcomes were recorded. Frequency and severity of adverse events remained within the established safety and tolerability profile of interferon beta-1b. INTERPRETATION: Effects on the rate of conversion to CDMS and the favourable long-term safety and tolerability profile support early initiation of treatment with interferon beta-1b, although a delay in treatment by up to 2 years did not affect long-term disability outcomes. FUNDING: Bayer Schering Pharma.
Original languageEnglish
JournalLancet neurology
Volume8
Issue number11
Pages (from-to)987-97
Number of pages11
ISSN1474-4422
DOIs
Publication statusPublished - 1 Nov 2009

Bibliographical note

Jette Lautrup Battistini (Jette Frederiksen) er med i Study Group. Tilføjet manuelt i PURE

    Research areas

  • Adult, Data Interpretation, Statistical, Disability Evaluation, Disease Progression, Double-Blind Method, Female, Humans, Interferon-beta, Kaplan-Meiers Estimate, Magnetic Resonance Imaging, Male, Multiple Sclerosis, Proportional Hazards Models, Questionnaires, Risk Assessment, Young Adult

ID: 30969801