Abstract Details

Title Effect of Fingolimod on Confirmed Improvement in Physical Disability: Post-Hoc Analyses of FREEDOMS I and TRANSFORMS

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 108

Objective

Background BACKGROUND: Fingolimod has consistently demonstrated superior efficacy over placebo and interferon-beta-1a in terms of both clinical and magnetic resonance imaging (MRI) outcome measures.

Design/Methods DESIGN/METHODS: Post-hoc analyses of FREEDOMS and TRANSFORMS were performed in order to estimate the efficacy of fingolimod on 3-month confirmed improvement in physical disability, as measured by the EDSS scale. Analyses were performed in patients with a baseline EDSS score ?2.0. Confirmed improvement was defined as a ?1.0 point decrease in patients with an EDSS score <5.5 confirmed after 3 months. For patients with a baseline score of 5.5 two different criteria's were tested, a ?0.5 point and ?1.0 point confirmed decrease.

Results RESULTS: Assuming a criterion of ?1.0 point decrease in patients with an EDSS score <5.5 and ?0.5 point decrease for patients with a baseline score of 5.5, fingolimod 0.5 mg increased the probability of 3-month confirmed improvement in EDSS score by 53% relative to placebo (HR=1.53; 95% CI 1.05-2.22; p=0.028). A similar increase was observed when a ?1 point confiormed improvement was required for all patients (HR=1.42; 95% CI 0.97-2.07; p=0.071). Additional analyses also assessed the treatment effects of fingolimod on 36 weeks (HR=2.04; 95% CI 1.24-3.36; p=0.005) and 48 weeks confirmed disability improvement (HR=1.82; 95% CI 1.02-3.25; p=0.044) compared to placebo. Similarly, requiring a ?1 point confirmed improvement for all patients had little impact on the estimated hazard ratios (36 weeks HR=1.81; p=0.021 and 48 weeks HR=1.56; p=0.14). Trends favouring fingolimod were also observed for 6-month confirmed improvement.

Conclusions CONCLUSIONS: In addition to delaying disability progression, treatment with fingolimod may also be associated with improvement in physical disability as measured by EDSS.

Authors/Disclosures
Niklas Bergvall PRESENTER	No disclosure on file
Nicolaos Sfikas (Novartis Pharma AG)	No disclosure on file
Katrina Paumier, PhD (Mitsubishi Tanabe Pharma America (MTPA))	Dr. Paumier has nothing to disclose.
Peter S. Chin, MD (Denali)	No disclosure on file
Davorka Tomic-Wallis, PhD (Biogen Idec)	No disclosure on file
Gary R. Cutter, PhD (University of Alabama At Birmingham)	Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for onsulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP, Tenmile.. Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb, CSL Behring, Cynata Therapeutics, DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.

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