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Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome
Journal article

Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome

  • Nagtegaal, Gijsbert JA Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands
  • Pohl, Christoph Department of Neurology, University Hospital of Bonn, Germany
  • Wattjes, Mike P Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands
  • Hulst, Hanneke E Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands
  • Freedman, Mark S Department of Medicine, Ottawa Hospital Research Institute, Canada
  • Hartung, Hans-Peter Neurology Clinic, Heinrich-Heine-Universität, Germany
  • Miller, David Institute of Neurology, National Hospital for Neurology and Neurosurgery, UK
  • Montalban, Xavier MS Centre of Catalonia, Hospital Vall d’Hebron, Spain
  • Kappos, Ludwig Department of Neurology, University of Basel and University Hospital, Switzerland
  • Edan, Gilles Service de Neurologie, Université of Rennes, France
  • Pleimes, Dirk Global Medical Affairs, Bayer HealthCare Pharmaceuticals, USA
  • Beckman, Karola Global Clinical Development, Bayer Pharma AG, Germany
  • Stemper, Brigitte Global Clinical Development, Bayer Pharma AG, Germany
  • Polman, Christoph H Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands
  • Sandbrink, Rupert Neurology Clinic, Heinrich-Heine-Universität, Germany
  • Barkhof, Frederik Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands
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  • 2013-7-10
Published in:
  • Multiple Sclerosis Journal. - SAGE Publications. - 2013, vol. 20, no. 2, p. 234-242
Neurology
Clinical Neurology
English Background: Multiple sclerosis (MS) is characterised by inflammatory lesions of the central nervous system. Interferon beta-1b (IFNB-1b) has been shown to improve clinical and magnetic resonance imaging (MRI) measures for patients with MS. Objective: To evaluate whether IFNB-1b in patients presenting with clinically isolated syndromes (CIS) prevented persisting T1 hypointensities on MRI (persistent black holes (PBHs)). Methods: In the placebo-controlled phase, patients ( n = 468) were initially randomised to IFNB-1b ( n = 292) or placebo ( n = 176) for two years or clinically definite MS (CDMS). In the open-label phase ( n = 418), both groups were offered IFNB-1b for up to five years. Lesions were classified as PBHs if T1 hypointensity persisted throughout the last available scan (minimum time one year). Results: A total of 435 patients were evaluable for analysis. The number of PBHs/patient was lower in the early rather than the delayed treatment arm during both phases (.42 vs .71, p = .0102 and .70 vs 1.17, p = .0121). Exploratory analyses identified baseline characteristics that affected rate of conversion. Conclusions: Although the rate of lesions that converted to PBH showed no significant differences between groups, the numbers of PBHs per patient out of new lesions was significantly lower in IFNB-1b patients compared to patients on placebo. Trial registration number: NCT00544037.
Language
  • English
Open access status
closed
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https://sonar.ch/global/documents/92692
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