Objective: To examine the proportions of patients with multiple sclerosis (MS) free from disease activity with fingolimod (Gilenya TM ) therapy compared with interferon beta-1a IM (IFN beta-1a). Background Fingolimod has demonstrated superior efficacy to placebo and IFN beta-1a in MS. Absence of disease activity is an important objective of treatment and was assessed post hoc via the composite endpoint 9disease-free status9. Design/Methods: Patients with relapsing-remitting MS were randomized to fingolimod 0.5mg or 1.25mg, or to 30mcg IFN beta-1a IM in a 12-month, double-blind, double-dummy study (TRANSFORMS). Disease-free status was defined as absence of gadolinium-enhancing (Gd+) lesions, new/enlarging T2 lesions, confirmed relapses and 3-month confirmed disability progression. Results: Among 1292 patients 1153 (89%) completed the study. Fingolimod resulted in more disease-free patients vs. IFN beta-1a over 12 months (0.5mg, 46%, p vs. 69% of IFN beta-1a patients were free of relapses (p vs. 92% were free of disability progression (p=0.498). For MRI measures 56% vs. 49% were free of new/enlarging T2 lesions (p=0.058) and 90% vs. 81% were free of Gd-enhancingT1 lesions (p Conclusions: Fingolimod therapy significantly increased the proportion of patients with MS who were free of disease activity compared with IFN beta-1a IM over 12 months. Supported by: Novartis Pharma AG, Basel, Switzerland. Disclosure: Dr. Khatri has received personal compensation for activities with Teva Neuroscience, Bayer Pharmaceuticals Corporation, Pfizer Inc, Medtronics, Biogen Idec, Serono, Inc., and Caridian. Dr. Khatri has received research support from Biogen Idec. Dr. Barkhof has received personal compensation for activities with Novartis, Biogen Idec, Merck-Serono, and Bayer-Schering as a consultant. Dr. Comi has received personal compensation for activities with Novartis, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Merck Serono, Bayer Schering, and Biogen Dompe. Dr. Jin has received personal compensation for activities with Novartis Pharma AG. Dr. Francis has received personal compensation for activities with Novartis as an employee. Dr. Francis holds stock and/or stock options in Novartis, which sponsored research in which Dr. Francis was involved as an investigator. Dr. Cohen has received personal compensation for activities with Biogen Idec, Eli Lilly & Company, Novartis, and Vaccinex. Dr. Cohen has received research support for activities with Biogen Idec, BioMS, Genzyme Corporation, Novartis, Synthon, and Teva Neuroscience.