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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

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 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. 
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 Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 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 Viatris. 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 Shionogi. 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.
Bruce A. Cree, MD, PhD, MAS, 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 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 Alexion. Dr. Cree has received personal compensation in the range of $5,000-$9,999 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 $10,000-$49,999 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.
Chun-Yen Cheng Chun-Yen Cheng has received personal compensation for serving as an employee of Bristol Myers Squibb. Chun-Yen Cheng has stock in Bristol Myers Squibb.
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) Dr. Kappos has nothing to disclose.