[S21.004] Oral Fingolimod (FTY720) Versus Interferon Beta-1a in RelapsingRemitting Multiple Sclerosis: Results from a Phase III Study (TRANSFORMS)

Jeffrey Cohen, Cleveland, OH, Jean Pelletier, Marseille, France, Ludwig Kappos, Basel, Switzerland, Xavier Montalban, Barcelona, Spain, Hans-Peter Hartung, Dusseldorf, Germany, Giancarlo Comi, Milan, Italy, Bhupendra O. Khatri, Milwaukee, WI, Frederik Barkhof, Amsterdam, The Netherlands, Tracy Stites, James Jin, East Hanover, NJ, Stacy Wu, Basel, Switzerland, Shreeram Aradhye, East Hanover, NJ, TRANSFORMS Study Group

OBJECTIVE: To report the 12-month efficacy, safety, and tolerability results from the TRANSFORMS study of oral fingolimod (FTY720) versus intramuscular interferon beta-1a (IFN-1a) in patients with relapsingremitting multiple sclerosis (RRMS). BACKGROUND: Oral fingolimod, a sphingosine 1-phosphate receptor modulator, reduced annualized relapse rate (ARR) by >50% and cumulative number of gadolinium-enhancing lesions by up to 80% in a 6-month, placebo-controlled phase II study in 281 patients with relapsing MS. TRANSFORMS is a 12-month phase III study comparing the efficacy and safety of oral fingolimod 0.5 or 1.25 mg once-daily versus intramuscular IFN-1a 30 g once-weekly in patients with RRMS. DESIGN/METHODS: This randomized, double-blind, double-dummy study included patients diagnosed with RRMS according to the 2005 revised McDonald criteria who were aged 1855 years with an Expanded Disability Status Scale (EDSS) score of 05.5 and with 1 relapse in the previous year or 2 relapses in the previous 2 years. The primary efficacy endpoint was ARR at month 12. Secondary measures included number of new/newly enlarging T2 lesions and time to 3-month confirmed disability progression on EDSS. Comprehensive safety assessments were conducted. RESULTS: 1292 patients (mean age, 36 years; 67% female) with RRMS were randomized to treatment and 1123 (87%) patients completed the study. At baseline, mean MS duration was 7.5 years, mean EDSS score was 2.2 and patients had a mean of 1.5 relapses in the past year and 2.2 in the past 2 years. Month 12 efficacy and safety results will be available for presentation at the 2009 AAN congress. CONCLUSIONS/RELEVANCE: Baseline patient demographics and disease characteristics in the TRANSFORMS study represent a population with active RRMS, which is consistent with those of previous phase III studies of available parenteral disease-modifying therapies. This trial will provide the first phase III efficacy and safety results comparing oral fingolimod with interferon IFN-1a. Supported by: Novartis Pharma AG, Basel, Switzerland.
Category - MS and Related Diseases - Clinical Science

Wednesday, April 29, 2009 2:45 PM

Scientific Sessions: Multiple Sclerosis: Clinical Trials (2:00 PM-3:30 PM)