Article Text

Research paper
Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT
  1. G Edan1,
  2. L Kappos2,
  3. X Montalbán3,
  4. C H Polman4,
  5. M S Freedman5,
  6. H-P Hartung6,
  7. D Miller7,
  8. F Barkhof8,
  9. J Herrmann9,
  10. V Lanius10,
  11. B Stemper10,
  12. C Pohl10,11,
  13. R Sandbrink6,10,
  14. D Pleimes12
  15. for the BENEFIT Study Group
  1. 1University of Rennes, Rennes, France
  2. 2University of Basel and University Hospital, Basel, Switzerland
  3. 3Department of Clinical Neuroimmunology, Hospital Vall d'Hebron, Barcelona, Spain
  4. 4VU University Medical Center, Amsterdam, The Netherlands
  5. 5Ottawa Hospital Research Institute, Ottawa, Canada
  6. 6Heinrich-Heine University, Düsseldorf, Germany
  7. 7National Hospital for Neurology and Neurosurgery, London, UK
  8. 8MS MRI Centre-Free University Hospital, Amsterdam, The Netherlands
  9. 9PAREXEL International GmbH, Berlin, Germany
  10. 10Bayer Pharma AG, Berlin, Germany
  11. 11Department of Neurology, University Hospital of Bonn, Bonn, Germany
  12. 12Bayer HealthCare Pharmaceuticals Inc, Whippany, New Jersey, USA
  1. Correspondence to Professor Ludwig Kappos, Neurology and Department of Research, University Hospital Basel, Petersgraben 4, Basel 4031, Switzerland; Ludwig.Kappos{at}usb.ch

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.

  • MULTIPLE SCLEROSIS
  • INTERFERON
  • INTERVENTIONAL
  • RANDOMISED TRIALS

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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