Article Text

Download PDFPDF

  1. Eli Silber1,
  2. L Kappos2,
  3. EW Radue3,
  4. P Connor4,
  5. M Amato5,
  6. L Zhang-Auberson6,
  7. D Haering6,
  8. G Francis7
  1. 1King's College Hospital, London
  2. 2Neurology and Department of Biomedicine University Hospital Basel
  3. 3University Hospital Basel
  4. 4St. Michael's Hospital, Canada
  5. 5University of Florence, Italy
  6. 6Novartis Pharma AG, Basel
  7. 7Novartis Pharmaceuticals Corporation, USA


Objectives To evaluate the long-term efficacy outcomes in patients with high-disease-activity switching from placebo to fingolimod, from the FREEDOMS extension study.

Methods Patients either continued on the fingolimod dose assigned in the core phase (continuous-group ‘c-group’) or were re-randomised from placebo to fingolimod (switch-group ‘s-group’). Clinical and MRI outcomes (Month 0–24, core/ Month 24–48, extension) for fingolimod 0.5mg are presented for the following high-disease-activity subgroups: Group-1 (n=110), interferon-beta (IFN) therapy in previous year and ≥ relapse in year-1 vs. year-2;; Group-2 (n=106), IFN therapy in previous year+≥1 relapse in year-1 with either ≥1 Gd+ T1 lesion or ≥9 T2 lesions at baseline; Group-3 (n=90), treatment-naïve rapidly evolving severe RRMS patients (≥2 relapses in year-1 and ≥1 baseline Gd+-lesion).

Results Annualized relapse rates were sustained from the core into extension phase for ‘c-group’ (Core/extension: Group-1: 0.16/0.20; Group-2: 0.23/0.25; Group-3: 0.26/0.20) and reduced in ‘s-group’ (Group-1: 0.62/0.29; Group-2: 0.56/0.28; Group-3: 0.62/0.18). Greater proportions of switch patients were free from new/enlarging T2-lesions (Group-1: 16.7%/16.7%; Group-2: 14.3%/28.6%; Group-3: 16.7%/66.7%) and Gd+-lesions; (Group-1: 14.3%/85.7%; Group-2: 12.5%/87.5%; Group-3: 16.7%/83.3%).

Conclusion Highly active patients switched to fingolimod showed significant improvement in clinical and MRI outcomes. Continuous fingolimod treatment was associated with sustained low clinical disease activity.


Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.