Fingolimod Therapy in Early Multiple Sclerosis: An Efficacy Analysis of the TRANSFORMS and FREEDOMS Studies by Time Since First Symptom. (31st March 2014)

• Record Type: Journal Article
• Authors: Agius, Mark; Meng, Xiangyi; Chin, Peter; Grinspan, Augusto; Hashmonay, Ronny
• Is Part Of: CNS neuroscience & therapeutics. Volume 20:Number 5(2014)
• Page Start: 446
• Page End: 451
• Publication Date: 2014-03-31
• Subjects: Neuropharmacology -- Periodicals; Central nervous system -- Diseases -- Effect of drugs on -- Periodicals; 612.8
• DOI: 10.1111/cns.12235
• Languages: English
• ISSNs: 1755-5930

Abstract

<abstract abstract-type="main" id="cns12235-abs-0001"> <title>Summary</title> <sec id="cns12235-sec-0001" sec-type="section"> <title>Aims</title> <p>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) <italic>β</italic>‐1a and placebo over 12 and 24 months, respectively.</p> </sec> <sec id="cns12235-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="cns12235-sec-0003" sec-type="section"> <title>Results</title> <p>Fingolimod 0.5 mg reduced annualized relapse rate by 73.4% (<italic>P </italic>=<italic> </italic>0.0002) versus IFN<italic>β</italic>‐1a IM and by 67.4% (<italic>P </italic><<italic> </italic>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 IFN<italic>β</italic>‐1a IM (mean number, 1.94 vs. 2.95; <italic>P </italic>=<italic> </italic>0.036) or placebo (4.1 vs. 10.7; <italic>P </italic><<italic> </italic>0.001); the mean number of gadolinium‐enhancing T1 lesions was significantly reduced versus placebo (0.3 vs. 1.1; <italic>P </italic><<italic> </italic>0.001).</p> </sec> <sec id="cns12235-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Fingolimod 0.5 mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course.</p> </sec> </abstract>