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Magnetic resonance imaging outcomes from a phase III trial of teriflunomide

  • Wolinsky, Jerry S Department of Neurology, The University of Texas Health Science Center at Houston, USA
  • Narayana, Ponnada A Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston, USA
  • Nelson, Flavia Department of Neurology, The University of Texas Health Science Center at Houston, USA
  • Datta, Sushmita Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston, USA
  • O’Connor, Paul St Michael’s Hospital, University of Toronto, Canada
  • Confavreux, Christian Service de Neurologie A, Hospices Civils de Lyon; Université Claude Bernard Lyon 1, France
  • Comi, Giancarlo Department of Neurology and Institute of Experimental Neurology, San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy
  • Kappos, Ludwig Department of Neurology, University Hospital Basel, Switzerland
  • Olsson, Tomas P Department of Clinical Neuroscience, Karolinska Institute, Sweden
  • Truffinet, Philippe Genzyme, a Sanofi company, Chilly Mazarin, France
  • Wang, Lin Sanofi, Bridgewater, USA
  • Miller, Aaron Corinne Goldsmith Dickinson Center for MS, Icahn School of Medicine at Mount Sinai USA
  • Freedman, Mark S University of Ottawa, The Ottawa Hospital Research Institute, Canada
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  • 2013-2-27
Published in:
  • Multiple Sclerosis Journal. - SAGE Publications. - 2013, vol. 19, no. 10, p. 1310-1319
Neurology
Clinical Neurology
English Objective: The purpose of this study was to determine the effects of oral teriflunomide on multiple sclerosis (MS) pathology inferred by magnetic resonance imaging (MRI). Methods: Patients ( n=1088) with relapsing MS were randomized to once-daily teriflunomide 7 mg or 14 mg, or placebo, for 108 weeks. MRI was recorded at baseline, 24, 48, 72 and 108 weeks. Annualized relapse rate and confirmed progression of disability (sustained ≥12 weeks) were the primary and key secondary outcomes. The principal MRI outcome was change in total lesion volume. Results: After 108 weeks, increase in total lesion volume was 67.4% ( p=0.0003) and 39.4% ( p=0.0317) lower in the 14 and 7 mg dose groups versus placebo. Other measures favoring teriflunomide were accumulated enhanced lesions, combined unique activity, T2-hyperintense and T1-hypointense component lesion volumes, white matter volume, and a composite MRI score; all were significant for teriflunomide 14 mg and most significant for 7 mg versus placebo. Conclusions: Teriflunomide provided benefits on brain MRI activity across multiple measures, with a dose effect evident on several markers. These effects were also consistent across selected subgroups of the study population. These findings complement clinical data showing significant teriflunomide-related reductions in relapse rate and disease progression, and demonstrate containment of MRI-defined disease progression.
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  • English
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hybrid
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https://sonar.ch/global/documents/232094
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