TY - JOUR T1 - Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study JF - Journal of Neurology, Neurosurgery & Psychiatry JO - J Neurol Neurosurg Psychiatry SP - 468 LP - 475 DO - 10.1136/jnnp-2015-310597 VL - 87 IS - 5 AU - Jeffrey A Cohen AU - Bhupendra Khatri AU - Frederik Barkhof AU - Giancarlo Comi AU - Hans-Peter Hartung AU - Xavier Montalban AU - Jean Pelletier AU - Tracy Stites AU - Shannon Ritter AU - Philipp von Rosenstiel AU - Davorka Tomic AU - Ludwig Kappos Y1 - 2016/05/01 UR - http://jnnp.bmj.com/content/87/5/468.abstract N2 - Objective The 12-month (M), phase 3, double-blind, randomised TRANSFORMS study demonstrated significant benefits of fingolimod 0.5 or 1.25 mg over interferon β-1a (IFNβ-1a) in patients with relapsing–remitting multiple sclerosis. We report the results of long-term (up to 4.5 years) extension of TRANSFORMS.Methods Patients randomised to fingolimod (0.5/1.25 mg) in the core phase continued the same dose (continuous-fingolimod) in the extension, whereas those on IFNβ-1a were re-randomised (1:1) to fingolimod (IFN-switch; IFN: 0.5/1.25 mg). Outcomes included annualised relapse rate (ARR), confirmed disability progression and MRI measures. Results are presented here for the continuous-fingolimod 0.5 mg and pooled IFN-switch groups.Results Of the 1027 patients who entered the extension, 772 (75.2%) completed the study. From baseline to the end of the study (EOS), ARR in patients on continuous-fingolimod 0.5 mg was significantly lower than in the IFN-switch group (M0–EOS: 0.17 vs 0.27). After switching to fingolimod (M0–12 vs M13–EOS), patients initially treated with IFN had a 50% reduction in ARR (0.40 vs 0.20), reduced MRI activity and a lower rate of brain volume loss. In a post hoc analysis, the proportion of IFN-switch patients with no evidence of disease activity increased by approximately 50% in the first year after switching to fingolimod treatment (44.3% to 66.0%). The safety profile was consistent with that observed in the core phase.Conclusions These results support a continued effect of long-term fingolimod therapy in maintaining a low rate of disease activity and sustained improved efficacy after switching from IFNβ-1a to fingolimod.Clinical trial registration No NCT00340834. ER -