Abstract Details

Title Fingolimod Reduces Annualized Relapse Rate in Patients with Relapsing-Remitting Multiple Sclerosis: FREEDOMS II Study Subgroup Analysis

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 102

Objective

Background BACKGROUND: FREEDOMS II is a two year, double-blind, randomized, placebo-controlled study evaluating patients receiving fingolimod 0.5mg and 1.25mg.

Design/Methods DESIGN/METHODS: Patient subgroups were based on 1) demographics: age, sex, and treatment history 2) baseline disease activity: number of relapses in previous 1 year or previous 2 years before study entry, baseline disability and MRI activity. Aggregate ARRs based on confirmed relapses for subgroups for the approved dose of 0.5mg are presented here.

Results RESULTS: 71.8% (779/1083) patients completed the study. ARR was similar in men (fingolimod 0.22 versus placebo 0.35; p=0.092, 38.5 % reduction) and women (fingolimod 0.21 versus placebo 0.41; p<0.001, 50.3%). ARR was reduced by >50% versus placebo in younger patients, age ?40 years (0.23 versus 0.48; p<0.001, 52.3%), and was effective in patients age >40years (0.18 versus 0.30; p=0.013, 38.5%). Previously treated and treatment-naive patients had less ARR versus placebo (0.23 versus 0.41, p<0.001, 44.3%; 0.15 versus 0.36, p=0.005, 57.9%). Other subgroup comparisons were: patients with mild disability (EDSS <3.0: 0.18 versus 0.39, p<0.001, 53.5%) and moderate-severe disability (EDSS ?3.0: 0.27 versus 0.43, p=0.019, 37%); patients with no Gd T1 lesions (0.18 versus 0.37, p<0.001, 50.4% ), 1-2 lesions (0.26 versus 0.36, p=0.203, 25.8%) and ?3 lesions (0.24 versus 0.65, p<0.001, 62.6%); relapses in the previous year: no relapse (0.12 versus 0.40, p=0.087, 70.2%), single relapse (0.19 versus 0.35, p<0.001, 47.1%) and ?2 relapses (0.27 versus 0.50, p=0.003, 46.1%); relapses in the previous 2 years: single relapse (0.15 versus 0.27, p=0.036, 43.8%), 2-3 relapses (0.25 versus 0.48, p<0.001, 48.2%), >5 relapses (0.30 versus 0.67, p=0.184, 54.8%).

Conclusions CONCLUSIONS: Treatment with fingolimod 0.5mg reduced ARR compared with placebo in the FREEDOMS II study irrespective of baseline demographic status, disease activity or disease severity.

Authors/Disclosures
Douglas S. Goodin, MD (Univ of Calif at San Francisco) PRESENTER	No disclosure on file
Douglas R. Jeffery, MD, PhD (Lake Norman Neurology At Piedmont Health Care)	No disclosure on file
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
Fred D. Lublin, MD, FAAN (Icahn School of Medicine At Mount Sinai)	Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche/Genentech. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurogene. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medimmune/Viela Bio/Horizon. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Receptos/Celgene/BMS. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Labcorp. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralight. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Entelexo. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Lublin has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Multiple entities. Dr. Lublin has stock in Avotres. Dr. Lublin has stock in Neuralight. The institution of Dr. Lublin has received research support from Brainstorm. The institution of Dr. Lublin has received research support from biogen. The institution of Dr. Lublin has received research support from NIH.
Horacio C. Kaufmann, MD, FAAN (NYU Langone Health - NYU Dysautonomia Center)	Dr. Kaufmann has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Theravance. Dr. Kaufmann has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Kaufmann has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Curasen Therapeutics. Dr. Kaufmann has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Kaufmann has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for AskBio. Dr. Kaufmann has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BioArctic. Dr. Kaufmann has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Kaufmann 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 Spinger. The institution of Dr. Kaufmann has received research support from Biogen. The institution of Dr. Kaufmann has received research support from Vaxxinity. Dr. Kaufmann has received publishing royalties from a publication relating to health care.
Ernst-Wilhelm Radue, MD (Medical Image Analysis Center)	Dr. Radue has nothing to disclose.
Kottil W. Rammohan, MD (University of Miami)	Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. The institution of Dr. Rammohan has received research support from Genentech. The institution of Dr. Rammohan has received research support from Genzyme. The institution of Dr. Rammohan has received research support from EMD Serono. The institution of Dr. Rammohan has received research support from Alexion.
Anthony Reder, MD (University of Chicago)	Dr. Reder has nothing to disclose.
Timothy L. Vollmer, MD, FAAN	The institution of Dr. Vollmer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen IDEC. The institution of Dr. Vollmer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech/Roche. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siranax. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Meyers Squib. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viela Bios. The institution of Dr. Vollmer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Vollmer has received research support from Rocky Mountain MS Center. The institution of Dr. Vollmer has received research support from Biogen. The institution of Dr. Vollmer has received research support from Actelion. The institution of Dr. Vollmer has received research support from Genentech/Roche. The institution of Dr. Vollmer has received research support from Anokion. The institution of Dr. Vollmer has received research support from TG Therapeutics.
Mark Agius, MD (Barrow Neurological Institute Dept of Neurology)	No disclosure on file
Tracy E. Stites, PhD	Dr. Stites has received personal compensation for serving as an employee of Novartis Pharmaceuticals. Dr. Stites has received stock or an ownership interest from Novartis Pharmaceuticals.
Bingbing Li	Bingbing Li has received personal compensation for serving as an employee of Novartis.
Linda Cappiello (Novartis)	No disclosure on file
	No disclosure on file
Peter A. Calabresi, MD, FAAN (Johns Hopkins University)	Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia. An immediate family member of Dr. Calabresi has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MyMD. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Myelin Repair Foundation. The institution of Dr. Calabresi has received research support from Genentech. Dr. Calabresi has received publishing royalties from a publication relating to health care. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Grant reveiwer with Myelin Repair Foundation. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker for CME with NYAS. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Academic CME.

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