SWITCHING THERAPY TO FINGOLIMOD IMPROVES CLINICAL AND MRI OUTCOMES

• Published in: Journal of neurology, neurosurgery and psychiatry Vol. 85; no. 10; pp. e4.54 - e4
• Main Authors: Silber, Eli, Kappos, L, Radue, EW, Connor, P, Amato, M, Zhang-Auberson, L, Haering, D, Francis, G
• Format: Journal Article
• Language: English
• Published: 01.10.2014
• ISSN: 0022-3050; 1468-330X
• DOI: 10.1136/jnnp-2014-309236.147

ObjectivesTo evaluate the long-term efficacy outcomes in patients with high-disease-activity switching from placebo to fingolimod, from the FREEDOMS extension study.MethodsPatients 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 greater than or equal to relapse in year-1 vs. year-2; ; Group-2 (n=106), IFN therapy in previous year+ greater than or equal to 1 relapse in year-1 with either greater than or equal to 1 Gd+ T1 lesion or greater than or equal to 9 T2 lesions at baseline; Group-3 (n=90), treatment-naive rapidly evolving severe RRMS patients ( greater than or equal to 2 relapses in year-1 and greater than or equal to 1 baseline Gd+-lesion).ResultsAnnualized 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%).ConclusionHighly active patients switched to fingolimod showed significant improvement in clinical and MRI outcomes. Continuous fingolimod treatment was associated with sustained low clinical disease activity.