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Abstract Details

Relapse-associated Worsening and Progression-independent Relapse Activity in Ozanimod-treated Participants with Relapsing Multiple Sclerosis from the RADIANCE and DAYBREAK Trials
Multiple Sclerosis
P6 - Poster Session 6 (8:00 AM-9:00 AM)
6-014
To determine the incidence and predictors of relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA) in participants treated with ozanimod.
Ozanimod was associated with significantly fewer relapses than interferon beta-1a (IFN) in phase 3 relapsing multiple sclerosis (RMS) trials and provided sustained control of disability progression over 5 years in an open-label extension (OLE) study.
Participants treated with ozanimod 0.46mg/d or 0.92mg/d or IFN 30μg/wk for 24 months in the phase 3 RADIANCE trial (NCT02047734) were eligible to enroll in an ozanimod 0.92mg OLE study (DAYBREAK?NCT02576717; data cutoff: 1 February 2022). Confirmed disability progression ([CDP]; ≥1-point increase in Expanded Disability Status Scale [EDSS] score from baseline, confirmed after 6 months) incidence was determined. RAW and PIRA were defined as previously described (Lublin et al., 2022). Kaplan-Meier analyses and univariable Cox proportional hazards regression were performed. 
363 participants who received continuous ozanimod and 346 who switched from IFN were included. In up to 8 years of follow-up, 75.9% of participants were free of 6-month CDP. Among participants with CDP, 44.3% and 54.5% of those treated with continuous ozanimod had RAW or PIRA, respectively, and 8% had both; 57.8% and 43.4% who switched from IFN to ozanimod had RAW or PIRA, respectively, and 4.8% had both. RAW was observed in 10.7% of participants treated with continuous ozanimod and in 13.9% who switched from IFN to ozanimod; PIRA was observed in 13.2% of participants treated with continuous ozanimod and in 10.4% who switched from IFN to ozanimod. In both treatment groups, nominally significant predictors of RAW included RADIANCE baseline EDSS score (positive association) and whole brain, cortical grey matter, and thalamic volumes (negative associations); these variables were not predictors of PIRA. 
In ozanimod-treated participants with RMS, RAW and PIRA contributed similarly to disability progression over 8 years.
Authors/Disclosures
Bruce A. Cree, MD, PhD, MAS, FAAN (UCSF, Multiple Sclerosis Center)
PRESENTER 		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.
Massimo Filippi, MD, FAAN (Ospedale San Raffaele, Neuroimaging Research Unit) Dr. Filippi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sanofi. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, Takeda. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and TEVA. Dr. Filippi has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. The institution of Dr. Filippi has received research support from Biogen Idec, Merck-Serono, Novartis, Roche, the Italian Ministry of Health, the Italian Ministry of University and Research, and Fondazione Italiana Sclerosi Multipla.
Jon Riolo, PhD Dr. Riolo has received personal compensation for serving as an employee of Bristol Myers Squib.
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.
Hans-Peter Hartung, MD, FAAN (Heinrich Heine University Medical Faculty) Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS Celgene. Dr. Hartung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Geneuro. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Neurology.
Xavier Montalban, MD, PhD, FAAN (Vall Hebron University Hospital-Multiple Sclerosis Centre of Catalonia) The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck/ EMD Serono. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hoffmann-La Roche. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BMS/ Celgene. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/ Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BIAL PD. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PeerVoice. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung Biosys. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas BioPharma. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion/ Janssen Pharmaceuticals. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS/ Celgene. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/ EMD Serono. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann-La Roche. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic Therapeutics. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viatris/ Mylan. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Dr. Montalban has received research support from Biogen. The institution of Dr. Montalban has received research support from Hoffmann-La Roche. The institution of Dr. Montalban has received research support from Sanofi/ Genzyme. The institution of Dr. Montalban has received research support from Merck/ EMD Serono. The institution of Dr. Montalban has received research support from Novartis. The institution of Dr. Montalban has received research support from Teva Pharmaceuticals. The institution of Dr. Montalban has received research support from Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received research support from BMS/ Celgene.
Sven G. Meuth (Uniklinik Düsseldorf, Klinik für Neurologie) Sven G. Meuth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. Sven G. Meuth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Almirall. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Sven G. Meuth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche.
Leorah A. Freeman, MD, PhD (Dell Medical School, The University of Texas at Austin) Dr. Freeman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Hoffman La-Roche. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech, Inc. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Freeman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Freeman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Freeman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Freeman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Dr. Freeman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Texas Neurological Society. Dr. Freeman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono/ Merck. The institution of Dr. Freeman has received research support from Genentech. The institution of Dr. Freeman has received research support from PCORI. The institution of Dr. Freeman has received research support from EMD Serono. The institution of Dr. Freeman has received research support from Sanofi. The institution of Dr. Freeman has received research support from MSAA. The institution of Dr. Freeman has received research support from National Multiple Sclerosis Society.
Tanuja Chitnis, MD, FAAN (Brigham and Women's Hospital) Dr. Chitnis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Chitnis has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche-Genentech. Dr. Chitnis has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave Biosciences. Dr. Chitnis has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. The institution of Dr. Chitnis has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Dr. Chitnis has received research support from Novartis. The institution of Dr. Chitnis has received research support from Sanofi. The institution of Dr. Chitnis has received research support from Octave. The institution of Dr. Chitnis has received research support from Genentech-Roche. The institution of Dr. Chitnis has received research support from Tiziana Life Sciences. The institution of Dr. Chitnis has received research support from Bristol-Myers Squibb. The institution of Dr. Chitnis has received research support from Wesley Clover.
Cristina Granziera, MD, PhD (Basel University Hospital) The institution of Prof. Granziera has received research support from Novartis. The institution of Prof. Granziera has received research support from Hoffmann La Roche. The institution of Prof. Granziera has received research support from Genzyme Sanofi. The institution of Prof. Granziera has received research support from Biogen.
Erik Deboer Erik Deboer has received personal compensation for serving as an employee of BMS.
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.
Jennifer L. Reardon Jennifer L. Reardon has received personal compensation for serving as an employee of Bristol Myers Squibb.
Chahin Pachai Chahin Pachai has received personal compensation for serving as an employee of Bristol Myers Squibb. Chahin Pachai 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.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel) Dr. Kappos has nothing to disclose.