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Abstract Details

Effects of Ozanimod on Information Processing Speed: Findings From the Phase 3 SUNBEAM and DAYBREAK Extension Trials
Multiple Sclerosis
P6 - Poster Session 6 (12:00 PM-1:00 PM)
9-017
In the phase 3 SUNBEAM study, ozanimod HCl 1mg improved IPS, measured with the Symbol Digit Modalities Test (SDMT, a component of a secondary endpoint), compared with interferon β-1a (IFN).
Evaluate long-term effects of ozanimod, a sphingosine 1-phosphate receptor modulator, on information processing speed (IPS) in relapsing multiple sclerosis (RMS) patients.
In the double-blind, double-dummy, SUNBEAM study (NCT02294058), adults (18–55 years) with RMS were randomized to once-daily oral ozanimod HCl 1 or 0.5mg, or weekly intramuscular IFN 30µg. SUNBEAM continued until the last participant was treated for 12 months; completers were eligible for an open-label extension study (DAYBREAK; NCT02576717) of ozanimod HCl 1mg. Patients randomized to IFN transitioned to ozanimod HCl 1mg 12?24 months after SUNBEAM baseline. This exploratory analysis reports the percentage of participants with clinically meaningful (≥4 point or ≥10%) improvement or worsening of SDMT scores at 12 and 24 months after SUNBEAM baseline in those initially randomized to ozanimod HCl 1mg or IFN.
In SUNBEAM, 447 participants were randomized to ozanimod HCl 1mg and 448 to IFN (mean [SD] 13.5 [2.9] months of IFN exposure). Mean (SD) baseline SDMT scores were 47.7 (13.7) and 47.1 (13.5), respectively. At 12 months, 37.0% (158/427) of the ozanimod HCl 1mg group and 27.9% (119/426) of the IFN group had SDMT improvement; 22.7% (97/427) and 29.8% (127/426), respectively, worsened. At month 24, 42.3% (116/274) of those who received continuous ozanimod and 35.6% (94/264) of those originally assigned to IFN had SDMT improvement; 22.3% (61/274) and 25.4% (67/264), respectively, worsened relative to SUNBEAM baseline.
In this exploratory analysis, the percentage of participants with SDMT improvement increased over 24 months of continuous ozanimod treatment. The percentage of participants with SDMT improvement was higher at month 24 than month 12 among those who transitioned from IFN to ozanimod during the latter 12 months.
Authors/Disclosures
John DeLuca, PhD, ABPP (Kessler Foundation)
PRESENTER
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 Alan 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 Mylan. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. 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 Gossamer Bio. 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. C. 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.
Hongjuan Liu Hongjuan Liu has received personal compensation for serving as an employee of BMS.
James K. Sheffield, MD (Receptos) 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 *USE ID 014384 Comi Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Giancarlo *USE ID 014384 Comi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board 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.