Abstract Details

Title Neurofilament Light Chains as a Marker of Concurrent and Future Active Disease in Relapsing Multiple Sclerosis: An Analysis of Baseline Data From the Phase 3 Ozanimod Clinical Trials

Topic Multiple Sclerosis

Presentation(s) S56 - MS Trials and Treatment (1:55 PM-2:06 PM)

Poster/Presentation
Number 006

Background NfL is released into serum/plasma and cerebrospinal fluid following axonal/neuronal injury and may serve as a biomarker for ongoing neurologic damage.

Objective To explore the relationship between plasma neurofilament light chain (NfL) levels and relapsing multiple sclerosis (RMS) disease activity in phase 3 ozanimod trials.

Design/Methods

In this post hoc analysis, NfL levels were measured in baseline serum samples from patients with RMS in two phase 3 trials (SUNBEAM and RADIANCE) that compared the oral sphingosine 1-phosphate receptor-1 and -5 modulator ozanimod HCl 0.5 or 1 mg/d with intramuscular interferon β-1a 30 µg/wk. NfL levels were analyzed in the overall study populations and categorically based on the number of gadolinium-enhancing (GdE) and T2 MRI lesions and on relapse rates.

Results

NfL levels were measured in 1,313 and 1,346 patients from RADIANCE and SUNBEAM respectively; mean (SD) baseline NfL levels were 18.6 (19.8) pg/mL in RADIANCE and 19.6 (16.1) pg/mL in SUNBEAM. In both studies, baseline NfL levels were higher in patients with more GdE and T2 lesions and increased incrementally with escalating lesion counts. No relationship was found between baseline NfL levels and number of relapses reported in the 12 or 24 months prior to initiation of treatment in either trial; however, patients who subsequently relapsed while on study treatment had higher baseline NfL levels than those who did not.

Conclusions

Based on data from the ozanimod phase 3 studies, these findings suggest that NfL levels may be used as a marker of acute disease in RMS, correlate with the number of GdE and T2 MRI lesions, and may be predictive of future relapses.

Authors/Disclosures
Sarah Harris PRESENTER	Sarah Harris has received personal compensation for serving as an employee of BMS. Sarah Harris has stock in BMS.
	No disclosure on file
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 EMD Serono. 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 Autobahn. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avotres. 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 $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Cree has received personal compensation in the range of $10,000-$49,999 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 $500-$4,999 for serving as a Consultant for Kyverna. Dr. Cree has received personal compensation in the range of $500-$4,999 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.
Lawrence Steinman, MD, FAAN (Stanford Medicine)	Dr. Steinman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Steinman has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for 180 Life Sciences. Dr. Steinman has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for BioAtla. Dr. Steinman has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Pasithea. Dr. Steinman has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Atreca. Dr. Steinman has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Wilmer Hale Cutler Pickering. Dr. Steinman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Steinman 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. Steinman has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for National Academy of Sciences. Dr. Steinman has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Gibson Dunn. The institution of Dr. Steinman has received research support from Roche. The institution of Dr. Steinman has received research support from Novartis. Dr. Steinman has received intellectual property interests from a discovery or technology relating to health care.
James K. Sheffield, MD (Dianthus Therapeutics)	Dr. Sheffield has received personal compensation for serving as an employee of BMS.
Diego Silva, MD, PhD	No disclosure on file
	No disclosure on file
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.

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