Abstract
To minimize the clinical burden associated with multiple sclerosis (MS), early control of focal and diffuse CNS disease activity is a treatment priority. A post hoc analysis was conducted to evaluate the onset of efficacy of fingolimod treatment in patients with relapsing MS. Data from patients who received fingolimod 0.5 mg or placebo during either of two 24-month, double-blind, randomized, parallel-group clinical trials (FREEDOMS and FREEDOMS II) were pooled for analysis. Efficacy outcomes were: time to first confirmed relapse; annualized relapse rate (ARR); proportions of patients free from T1 gadolinium-enhancing lesions or new/newly enlarged T2 lesions; percentage brain volume loss (BVL); and change in Multiple Sclerosis Functional Composite (MSFC) z-score from baseline to 6 months. An early benefit was seen with fingolimod (N = 783) vs. placebo (N = 773) for ARR at both 3 and 6 months (3 months, 0.32 vs. 0.52, p = 0.0015; 6 months, 0.21 vs. 0.45, p < 0.0001). Time to first relapse was also delayed with fingolimod vs. placebo from day 48 onwards. At 6 months, more patients in the fingolimod group than in the placebo group were free from new MRI activity (65.3 vs. 40.5 %, p < 0.0001) and had less BVL (37.1 % reduction vs. placebo, p < 0.001). MSFC z-score favored fingolimod over placebo at 6 months, with improvements noted in 9-Hole Peg Test and Paced Auditory Serial Addition Test scores. Improvements in outcomes related to relapses, MRI, disability, cognition, and BVL occurred within 6 months of treatment initiation with fingolimod.Electronic supplementary materialThe online version of this article (doi:10.1007/s00415-015-7978-y) contains supplementary material, which is available to authorized users.
Highlights
Electronic supplementary material The online version of this article contains supplementary material, which is available to authorized users.Early reduction of disease activity is an important therapeutic goal for patients with multiple sclerosis (MS) to minimize neuro-axonal damage, prevent irreversible accumulation of disability and prolong survival [1, 10]
At 3 months, fingolimod reduced annualized relapse rate (ARR) compared with placebo (38.5 % reduction, p = 0.0015); this treatment effect was maintained over months 3–6 (53.3 % reduction, p \ 0.0001; Table 1)
Brain volume loss Number of patients Mean Percentage brain volume change (PBVC) from baseline Reduction vs. placebo (%) p value vs. placebod
Summary
Electronic supplementary material The online version of this article (doi:10.1007/s00415-015-7978-y) contains supplementary material, which is available to authorized users. The initial phase 2 study of oral fingolimod (FTY720; GilenyaÒ, Novartis Pharma AG, Basel, Switzerland) in patients with relapsing MS showed reductions in inflammatory activity evident on magnetic resonance imaging (MRI) as early as 2 months into treatment; reductions in annualized relapse rate (ARR) were reported within 6 months, albeit using higher doses of fingolimod than the approved, once-daily 0.5 mg dose [12] At this lower dose, fingolimod significantly reduced clinical and MRI disease activity compared with interferon b-1a i.m. FREEDOMS and FREEDOMS II were 24-month, double-blind, randomized, parallel-group clinical trials comparing the efficacy and safety of two oral doses of fingolimod (0.5 and 1.25 mg/day) with placebo in patients 18–55 years of age with active relapsing–remitting MS (RRMS) In both trials, standardized MRI scans were performed at screening, 6, 12, and 24 months after initiation of treatment. ARRs in the two treatment arms were compared using a Poisson
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