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Abstract Details

Effects of Ozanimod on Cognitive Processing Speed: Findings From the Phase 3 SUNBEAM and DAYBREAK Extension Trials
Multiple Sclerosis
P6 - Poster Session 6 (5:30 PM-6:30 PM)
3-001
In the phase 3 SUNBEAM trial (NCT02294058), ozanimod treatment improved CPS vs interferon β-1a (IFN), as measured with the Symbol Digit Modalities Test (SDMT), in participants with RMS over 12M. 

To evaluate the long-term effects of ozanimod on cognitive processing speed (CPS) in relapsing multiple sclerosis (RMS) patients over 60 months (M).

In the double-blind, double-dummy, SUNBEAM trial, adults (18?55 years) with RMS were randomized to once-daily oral ozanimod 0.92 or 0.46mg, or weekly intramuscular IFN 30µg. SUNBEAM continued until the last participant was treated for 12M; completers were eligible for an open-label extension (OLE) trial (DAYBREAK?NCT02576717) of ozanimod 0.92mg. This exploratory analysis reports the percentage of participants with clinically meaningful (≥4 point) SDMT improvement or worsening relative to SUNBEAM baseline at 12M, and at OLE M12, M36, and M60 in those initially randomized to ozanimod 0.92mg or IFN.
SUNBEAM participants (n=397, ozanimod 0.92mg; n=395, IFN) who entered the OLE were analyzed. Mean (SE) baseline SDMT scores were 48.0 (0.69) and 47.4 (0.68), respectively. At SUNBEAM M12, 34.5% (137/397) and 27.8% (110/395) of participants randomized to ozanimod 0.92mg and IFN, respectively, had SDMT improvement, and 23.2% (92/397) and 28.1% (111/395) worsened. At OLE M12, improvement was seen in 43.2% (171/396) of those who received continuous ozanimod and 34.8% (135/388) of those originally assigned to IFN; 19.9% (79/396) and 24.7% (96/388) worsened, respectively. At OLE M36, 40.0% (144/360) and 40.1% (137/342) improved; 23.1% (83/360) and 28.1% (96/342) worsened. At OLE M60, 41.5% (134/323) and 36.8% (112/304) improved; 26.0% (84/323) and 27.3% (83/304) worsened.
The percentage of participants with CPS improvement increased during the first 2?3 years of ozanimod treatment, then maintained with continuous ozanimod treatment. The percentage of participants with CPS improvement who previously received IFN reached a similar proportion within 3 years after switching to ozanimod.
Authors/Disclosures
Jon Riolo, PhD
PRESENTER
Dr. Riolo has received personal compensation for serving as an employee of Bristol Myers Squib.
John DeLuca, PhD, ABPP (Kessler Foundation) Dr. DeLuca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. DeLuca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. DeLuca has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Celgene. Dr. DeLuca has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. DeLuca has received research support from Biogen.
Jeffrey A. Cohen, MD (Cleveland Clinic) Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FiND. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for INMune. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sage.
Bruce A. Cree, MD, PhD, MCR, FAAN (UCSF, Multiple Sclerosis Center) 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 $500-$4,999 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 as a Consultant for Boston Pharma. 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. Dr. Cree has received publishing royalties from a publication relating to health care.
Chun-Yen Cheng No disclosure on file
James K. Sheffield, MD (Dianthus Therapeutics) Dr. Sheffield has received personal compensation for serving as an employee of BMS.
Diego Silva (Bristol-Myers Squibb Company) Diego Silva has received personal compensation for serving as an employee of BMS. Diego Silva has received stock or an ownership interest from BMS.
Giancarlo Comi, MD (University Vita-Salute) Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aspen Healthcare. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Rewind.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel) The institution of Dr. Kappos has received research support from Bayer. The institution of Dr. Kappos has received research support from Biogen. The institution of Dr. Kappos has received research support from Genentech. The institution of Dr. Kappos has received research support from Genzyme. The institution of Dr. Kappos has received research support from Janssen. The institution of Dr. Kappos has received research support from Merck Serono. The institution of Dr. Kappos has received research support from Minoryx. The institution of Dr. Kappos has received research support from Novartis. The institution of Dr. Kappos has received research support from Roche. The institution of Dr. Kappos has received research support from Sanofi. The institution of Dr. Kappos has received research support from Santhera. The institution of Dr. Kappos has received research support from Swiss MS Society, Swiss National Research Foundation, European Union, Roche Research Foundation, Innosuisse. The institution of Dr. Kappos has received research support from Shionogi. The institution of Dr. Kappos has received research support from Japan Tobacco. The institution of Dr. Kappos has received research support from Auriga Vision AG. The institution of Dr. Kappos has received research support from EMD Serono. The institution of Dr. Kappos has received research support from Glaxo Smith Kline. The institution of Dr. Kappos has received research support from Wellmera AG. The institution of Dr. Kappos has received research support from Eli Lilly (Suisse) SA. The institution of Dr. Kappos has received research support from Bristol Myers Squibb. The institution of Dr. Kappos has received research support from Celltrion Inc. Dr. Kappos has received intellectual property interests from a discovery or technology relating to health care.