Abstract Details

Title Effect of Fingolimod in Patients with No Disability as Measured by EDSS at Baseline: Post-Hoc Analyses of FREEDOMS I and II

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 124

Objective

Background BACKGROUND: Overall efficacy of fingolimod has been assessed in two placebo-controlled Phase 3 trials, FREEDOMS I and II.

Design/Methods DESIGN/METHODS: Post-hoc analyses of clinical and MRI endpoints in FREEDOMS and FREEDOMS II were conducted in the subgroup of patients with an EDSS baseline score of 0. Outcomes included annualized relapse rate (ARR), time to 3-month confirmed disability progression (CDP), percent change from baseline in brain volume, number of gadolinium enhancing T1 lesions (GEL), and number of new/newly enlarged T2 lesions (NEL).

Results RESULTS: Fingolimod 0.5 mg (n=36 and 32) reduced ARR by 59 % and 78% (p: 0.012) vs placebo (n=24 and 30) in FREEDOMS I and II, respectively. Hazard ratios (HR) of CDP with fingolimod 0.5 mg vs. placebo were 0.86 and 1.69 in FREEDOMS I and II. Reductions vs. placebo in mean GEL count were 82% (p: <0.001) and 100% (p: <0.001), in FREEDOMS I and II. Furthermore, fingolimod 0.5 mg reduced mean NEL count by 71% (p < 0.001) and 83% (p < 0.001) over 24 months vs placebo, in FREEDOMS I and II. Results for fingolimod 1.25 mg (n=32 and 30) vs. placebo were consistent with those observed for 0.5 mg with the exception of CDP in FREEDOMS II (HR: 0.73).

Conclusions CONCLUSIONS: Our findings suggest a similar treatment effect of fingolimod in patients with an EDSS baseline score of 0 as in the overall study population. The larger than 1 estimated HR of CDP with fingolimod in patients with an EDSS score of 0 in FREEDOMS II suggests that defining CDP by an increase of 1 point in this subgroup may be prone to especially high measurement variability.

Authors/Disclosures
Nicolaos Sfikas (Novartis Pharma AG) PRESENTER	No disclosure on file
Niklas Bergvall	No disclosure on file
Peter S. Chin, MD (Denali)	No disclosure on file
Davorka Tomic-Wallis, PhD (Biogen Idec)	No disclosure on file
	No disclosure on file
	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.
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.
	No disclosure on file
Douglas R. Jeffery, MD, PhD (Lake Norman Neurology At Piedmont Health Care)	No disclosure on file
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.

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