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Abstract Details

Efficacy and Safety of Fingolimod 0.5 mg and 0.25 mg Versus Glatiramer Acetate 20 mg in Patients with Relapsing-Remitting Multiple Sclerosis - ASSESS Study Group
Multiple Sclerosis
S56 - MS Trials and Treatment (2:28 PM-2:39 PM)
009
Fingolimod 0.5 mg has demonstrated superior efficacy over placebo and interferon β-1a in Phase 3 trials. Head-to-head comparisons of the efficacy and safety of disease-modifying therapies are important in informing treatment decisions in clinical practice.

To evaluate whether fingolimod (0.5 mg and 0.25 mg) has superior efficacy compared to glatiramer acetate (GA) 20 mg in reducing disease activity over 12 months in patients with relapsing-remitting multiple sclerosis.

 

 

In ASSESS, a Phase 3b, randomized, multicenter, rater- and dose-blinded study, eligible patients were randomized to receive once-daily oral fingolimod 0.5 mg (N=352), 0.25 mg (N=370), or subcutaneous GA 20 mg (N=342). Superiority of the fingolimod doses was tested hierarchically: 0.5 mg versus GA followed by 0.25 mg versus GA. The primary endpoint was reduction in annualized relapse rate (ARR), and secondary endpoints were MRI measures of disease activity at 12 months. Safety and tolerability were assessed.

 

Overall, 859 (80.7%) patients completed the study. Over 12 months, ARRs with fingolimod 0.5 mg and GA were 0.153 and 0.258, respectively (relative reduction [RR], 40.7%; p=0.0138); fingolimod 0.25 mg achieved a numerical RR of 14.6% but did not reach statistical significance. Compared to GA, fingolimod 0.5 mg and 0.25 mg significantly reduced the mean number of new/newly enlarged T2 (RR, 54.4% and 42.1%, respectively; p<0.0001) and gadolinium-enhancing T1 lesions (RR, 55.6% for both doses; p=0.0167 and p=0.0011, respectively). Adverse events (AEs) reported with both fingolimod doses were consistent with the known safety profile. More discontinuations from the study drug were reported with GA due to injection-related AEs, consent withdrawal and unsatisfactory therapeutic effects.

 

Fingolimod 0.5 mg is the optimal efficacious dose and is the first and only disease-modifying therapy to show superior efficacy in reducing disease activity versus GA in a controlled head-to-head study. Safety findings were consistent with the established safety profile of fingolimod.
Authors/Disclosures
Bruce A. Cree, MD, PhD, MAS, FAAN (UCSF, Multiple Sclerosis Center)
PRESENTER
The institution of Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Autobahn. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avotres. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuron23. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal/Sandoz. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. The institution of Dr. Cree has received research support from Genentech. The institution of Dr. Cree has received research support from Kyverna. Dr. Cree has received publishing royalties from a publication relating to health care.
Myla D. Goldman, MD, MSc, FAAN (Virginia Commonwealth University) Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Seronon. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen, IDEC. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentec. Dr. Goldman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ADAMAS. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharmceuticals. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich Biosciences. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brainstorm Cell Therapeutics Ltd., .
John Corboy, MD, FAAN (U of Colorado School of Medicine) Dr. Corboy has received personal compensation for serving as an employee of U of Coloado. Dr. Corboy has received personal compensation for serving as an employee of Rocky Mountain MS Center. Dr. Corboy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Mylan. Dr. Corboy has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squib. Dr. Corboy has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. Dr. Corboy has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Neurological Association. Dr. Corboy has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Mylan. The institution of Dr. Corboy has received research support from MedDay. The institution of Dr. Corboy has received research support from Novartis. The institution of Dr. Corboy has received research support from NMSS. The institution of Dr. Corboy has received research support from PCORI. The institution of Dr. Corboy has received research support from EMD Serono.
Barry A. Singer, MD Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Singer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Singer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Greenwich. Dr. Singer has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Novartis. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Singer has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb (Celgene). Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Singer has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Horizon. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Jannsen. The institution of Dr. Singer has received research support from AbbVie. The institution of Dr. Singer has received research support from Biogen. The institution of Dr. Singer has received research support from Novartis. The institution of Dr. Singer has received research support from Sanofi. The institution of Dr. Singer has received research support from Greenwich. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a National Medical Advisory Board with Express Scripts-Cigna.
Edward Fox, MD, PhD, FAAN Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Fox has received research support from Biogen. The institution of Dr. Fox has received research support from Genentech. The institution of Dr. Fox has received research support from Celgene - BMS. The institution of Dr. Fox has received research support from Chugai. The institution of Dr. Fox has received research support from Novartis. The institution of Dr. Fox has received research support from EMD-Serono. The institution of Dr. Fox has received research support from TG Therapeutics. The institution of Dr. Fox has received research support from AbbVie. The institution of Dr. Fox has received research support from Sanofi Genzyme. The institution of Dr. Fox has received research support from AbbVie.
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ) Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has stock in NeuroRx.
Corey C. Ford, MD, PhD, FAAN (University of New Mexico Health Sciences Center) No disclosure on file
Bianca Weinstock-Guttman, MD (Department of Neurology, University At Buffalo) Dr. Weinstock-Guttman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Weinstock-Guttman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Weinstock-Guttman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme &Sanofi. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen . Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Weinstock-Guttman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Weinstock-Guttman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Weinstock-Guttman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Weinstock-Guttman has received personal compensation in the range of $0-$499 for serving as a Reviewer with NIH.
Amit Bar-Or, MD, FRCPC (University of Pennsylvania) Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. The institution of Dr. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.
Susanne Mientus No disclosure on file
Daniel Sienkiewicz (Novarits Pharmaceuticals) No disclosure on file
No disclosure on file
Rajesh Karan (Novartis Pharma AG - Neuroscience Development Unit) Rajesh Karan has received personal compensation for serving as an employee of Novartis. Rajesh Karan has received stock or an ownership interest from Novartis.
Nadia Tenenbaum, MD (EMD Serono Research & Development Institute) Dr. Tenenbaum has received personal compensation for serving as an employee of EMS Serono. Dr. Tenenbaum has stock in EMS Serono.