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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
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 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).
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 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, FÂ鶹´«Ã½Ó³»­ (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.
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.
No disclosure on file
Ludwig Kappos, MD, FÂ鶹´«Ã½Ó³»­ (RC2NB, University Hospital Basel) Dr. Kappos has nothing to disclose.