Abstract Details

Title Eight-point Reliable Change on Symbol Digit Modalities Test with Ozanimod: Findings from the Phase 3 SUNBEAM and DAYBREAK Extension Trials

Topic Multiple Sclerosis

Presentation(s) P6 - Poster Session 6 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-015

Objective To evaluate long-term effects of ozanimod on cognitive processing speed (CPS) in participants with relapsing multiple sclerosis (RMS) using a Symbol Digit Modalities Test (SDMT) change of 8 points.

Background

In the SUNBEAM trial (NCT02294058), ozanimod improved CPS versus interferon β-1a (IFN) based on ≥4-point SDMT improvement. Recently, it was suggested that an 8-point SDMT change better represents statistically reliable individual-level change.

Design/Methods The double-blind SUNBEAM trial randomized adults with RMS to oral ozanimod 0.92mg/d or 0.46mg/d or intramuscular IFN 30µg/wk for ≥12 months. Completers were eligible for an open-label extension (OLE) trial (DAYBREAK; NCT02576717) of ozanimod 0.92mg. We analyzed the percentage of participants with ≥8-point SDMT improvement or worsening compared with SUNBEAM baseline at SUNBEAM M12 (SUN-M12), OLE-M12, OLE-M36, and OLE-M60 in those randomized to ozanimod 0.92mg/d or IFN. P-values are nominal.

Results Among SUNBEAM participants (n=397, ozanimod 0.92mg; n=395, IFN) who entered the OLE, mean (SE) baseline SDMT scores were 48.0 (0.69) and 47.4 (0.68), respectively. At SUN-M12, 16.1% (64/397) and 9.1% (36/395), respectively, had ≥8-point SDMT improvement (P=0.005), and 11.6% (46/397) and 11.6% (46/395), respectively, worsened ≥8 points (P=0.970). At OLE-M12, 21.2% (84/396) of those who received continuous ozanimod improved and 17.0% (66/388) of those who started on IFN improved (P=0.219); 11.6% (46/396) and 13.1% (51/388), respectively, worsened (P=0.580). At OLE-M36, 22.5% (81/360) and 18.1% (62/342), respectively, improved (P=0.291); 13.6% (49/360) and 14.0% (48/342), respectively, worsened (P=0.674). At OLE-M60, 24.5% (79/323) and 19.7% (60/304), respectively, improved (P=0.320); 14.6% (47/323) and 15.8% (48/304), respectively, worsened (P=0.885).

Conclusions Compared with the IFN group, participants in the ozanimod group were significantly more likely to achieve 8-point SDMT improvement at SUN-M12. When IFN-treated participants switched to ozanimod, statistical group differences disappeared. After both SUNBEAM and the OLE (6–7 years total), the proportion of participants with 8-point improvement in the continuous-ozanimod group remained numerically higher.

Authors/Disclosures
James Appio PRESENTER	James Appio has received personal compensation for serving as an employee of Bristol Myers Squibb. James Appio has stock in Bristol Myers Squibb.
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.
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.
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.
Jon Riolo, PhD	Dr. Riolo has received personal compensation for serving as an employee of Bristol Myers Squib.
Andrew Thorpe	No disclosure on file
Ralph H. Benedict, PhD (University At Buffalo)	Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic Therapeutics. Dr. Benedict has received intellectual property interests from a discovery or technology relating to health care.

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