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Abstract Details

Ofatumumab Reduces Clinical and Radiological Activity in People with Recently Diagnosed Treatment-naive Relapsing Multiple Sclerosis Irrespective of Baseline Serum Neurofilament Light Chain Levels
Multiple Sclerosis
P9 - Poster Session 9 (8:00 AM-9:00 AM)
6-008
Data from the Phase 3 ASCLEPIOS I/II trials (ofatumumab versus teriflunomide in pwRMS) demonstrated that baseline sNfL levels were prognostic for on-study lesion formation in the overall population, including a subgroup of RDTN participants. 
To compare the efficacy of ofatumumab versus teriflunomide in reducing relapses and new/enlarging T2 (neT2) lesions in recently diagnosed (within 3 years) treatment-naive (RDTN) people with relapsing multiple sclerosis (pwRMS) based on their baseline serum neurofilament light chain (sNfL) levels. 

A baseline sNfL cut-off was predefined by the median sNfL value for the overall population across the ASCLEPIOS I/II trials; RDTN participants were stratified into high (≥median [9.3 pg/mL]) and low (<9.3 pg/mL) sNfL categories. Adjusted annualized relapse rates (ARR) and annualized neT2 lesion rates were assessed with ofatumumab versus teriflunomide in each sNfL category over the study duration (up to 30 months). The effect of treatment on the proportion of participants achieving no evidence of disease activity (NEDA-3) at Month 12 and 24 was also compared within each sNfL category.

Across 576 RDTN participants with baseline sNfL available, annualized relapse rates were reduced by 63.4% (p=0.002) and 37.2% (p=0.119) in the high and low sNfL categories, respectively, with ofatumumab versus teriflunomide. Ofatumumab reduced the annualized rate of neT2 lesions by 85.5% and 85.8% versus teriflunomide for high and low sNfL categories, respectively (both p<0.001). A higher proportion of participants achieved NEDA-3 status with ofatumumab versus teriflunomide treatment, regardless of baseline sNfL levels (p<0.001 in both sNfL groups at all timepoints).

Ofatumumab was consistently associated with reductions in clinical and radiological activity versus teriflunomide in RDTN participants regardless of their baseline sNfL levels. The results support the benefit of using high-efficacy therapies, such as ofatumumab, at an early stage in the MS disease course irrespective of sNfL levels.

Authors/Disclosures
Gabriel Pardo, MD, FAAN (Oklahoma Medical Research Foundation)
PRESENTER
Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche Genentech. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi Genzyme. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Pardo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Horizon Therapeutics. Dr. Pardo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion Pharmaceuticals.
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.
Anne H. Cross, MD, FAAN (Washington University School of Medicine) Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech / F. Hoffman la Roche. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizon Pharmaceuticals. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen . Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb . Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave. Dr. Cross 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. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Consortium of MS Centers. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. The institution of Dr. Cross has received research support from Genentech. Dr. Cross has received intellectual property interests from a discovery or technology relating to health care.
Jens Kuhle, MD Dr. Kuhle has nothing to disclose.
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. 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. 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. 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. The institution of Dr. Montalban has received research support from BMS/ Celgene.
Natalia Khachanova (Russian National Research Medical University N.I. Pirgov) Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson&Johnson. Natalia Khachanova has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi-Aventis. Natalia Khachanova has received research support from Sanofi-Aventis. Natalia Khachanova has received research support from Roche. Natalia Khachanova has received research support from Merck. Natalia Khachanova has received research support from Novartis. Natalia Khachanova has received research support from Actelion Pharmaceuticals. Natalia Khachanova has received research support from TG Therapeutics.
Alit Bhatt No disclosure on file
Rebecca Piccolo, PhD (Novartis) Dr. Piccolo has received personal compensation for serving as an employee of Novartis. Dr. Piccolo has stock in Novartis.
Jing Xi (Novartis) No disclosure on file
Ibolya Boer Ibolya Boer has received personal compensation for serving as an employee of Novartis AG.
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ) Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has stock in NeuroRx.
Enrique Alvarez, MD, PhD (University of Colorado) Dr. Alvarez has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene/BMS. The institution of an immediate family member of Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. The institution of Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Motric Bio.
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden) Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS Celgene. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS Celgene. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Ziemssen has received research support from Biogen. The institution of Dr. Ziemssen has received research support from Novartis. The institution of Dr. Ziemssen has received research support from Merck. The institution of Dr. Ziemssen has received research support from Sanofi. The institution of Dr. Ziemssen has received research support from Celgene.