AIMS: The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis (MS) relapses and magnetic resonance imaging lesions compared with intramuscular (IM) interferon (IFN) β-1a and placebo over 12 and 24 months, respectively. METHODS: To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course, post hoc subgroup analyses of TRANSFORMS (n = 272) and FREEDOMS (n = 217) data were conducted in patients who experienced their first MS symptom <3 years before randomization. RESULTS: Fingolimod 0.5 mg reduced annualized relapse rate by 73.4% (P = 0.0002) versus IFNβ-1a IM and by 67.4% (P < 0.0001) versus placebo in patients with <3 years since first symptom; respective reductions were 45.4% and 51.4% in subgroups of patients with ≥3 years since first symptom. For patients with <3 years since their first symptom, significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFNβ-1a IM (mean number, 1.94 vs. 2.95; P = 0.036) or placebo (4.1 vs. 10.7; P < 0.001); the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; P < 0.001). CONCLUSION: Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.
RCT Entities:
AIMS: The phase 3 TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis (MS) relapses and magnetic resonance imaging lesions compared with intramuscular (IM) interferon (IFN) β-1a and placebo over 12 and 24 months, respectively. METHODS: To investigate the efficacy of fingolimod at the approved 0.5 mg dose in patients early in the MS disease course, post hoc subgroup analyses of TRANSFORMS (n = 272) and FREEDOMS (n = 217) data were conducted in patients who experienced their first MS symptom <3 years before randomization. RESULTS:Fingolimod 0.5 mg reduced annualized relapse rate by 73.4% (P = 0.0002) versus IFNβ-1a IM and by 67.4% (P < 0.0001) versus placebo in patients with <3 years since first symptom; respective reductions were 45.4% and 51.4% in subgroups of patients with ≥3 years since first symptom. For patients with <3 years since their first symptom, significantly fewer new/newly enlarged T2 lesions were observed with fingolimod versus IFNβ-1a IM (mean number, 1.94 vs. 2.95; P = 0.036) or placebo (4.1 vs. 10.7; P < 0.001); the mean number of gadolinium-enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; P < 0.001). CONCLUSION:Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.
Authors: Simon Zhornitsky; Jamie Greenfield; Marcus W Koch; Scott B Patten; Colleen Harris; Winona Wall; Katayoun Alikhani; Jodie Burton; Kevin Busche; Fiona Costello; Jeptha W Davenport; Scott E Jarvis; Dina Lavarato; Helene Parpal; David G Patry; Michael Yeung; Luanne M Metz Journal: PLoS One Date: 2015-04-13 Impact factor: 3.240
Authors: Bruce A C Cree; Douglas L Arnold; Mark Cascione; Edward J Fox; Ian M Williams; Xiangyi Meng; Lesley Schofield; Nadia Tenenbaum Journal: Ther Adv Neurol Disord Date: 2018-05-20 Impact factor: 6.570
Authors: Morten Riemenschneider; Lars G Hvid; Steffen Ringgaard; Mikkel K E Nygaard; Simon F Eskildsen; Thor Petersen; Egon Stenager; Ulrik Dalgas Journal: BMJ Open Date: 2021-01-12 Impact factor: 2.692