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Abstract Details

Characterization of Neurological Biomarkers in Patients with Early Relapsing Multiple Sclerosis and Comparison to Healthy Controls: Year 1 Interim Analysis of the ENLIGHTEN Study of Ozanimod
Multiple Sclerosis
P6 - Poster Session 6 (11:45 AM-12:45 PM)
1-009
Evaluate the effect of 1 year of ozanimod on biomarkers of axonal and astrocytic damage in patients with early relapsing multiple sclerosis (RMS) and compare biomarker concentrations in patients with RMS vs healthy controls. 
Glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and Tau are markers of astrocytic and neuronal damage and serve as biomarkers of RMS disease activity and progression.

ENLIGHTEN (NCT04140305) is an ongoing, multicenter, single-arm, open-label study of ozanimod 0.92 mg in adults with early RMS (≤1 prior disease-modifying therapy; Expanded Disability Status Scale score of ≤3.5; ≤5 years since RMS diagnosis). GFAP, NfL, and Tau concentrations were assessed at baseline and 12 months (Quanterix Neuro 4-plex assay) in plasma samples from ENLIGHTEN participants and commercial samples from healthy volunteers. Spearman correlation analysis, Wilcoxon test, and Mann Whitney U test were used to evaluate and compare concentrations. Data cutoff: 2/7/2024.
Of 163 patients with RMS and biomarker data, 79% were female; 86% White; and 68% untreated. Age and gender were not significantly different between patients with RMS and 210 healthy controls. Baseline NfL levels were significantly higher in untreated than previously treated patients with RMS (P=0.01); however, baseline GFAP and Tau levels did not differ between untreated and treated patients. Baseline NfL, GFAP, and Tau levels were higher in patients with RMS than in healthy controls (P<0.0001). After 1 year of ozanimod, NfL, GFAP, and Tau levels were all reduced from baseline (P<0.0001, P=0.006, P=0.01, respectively), and NfL levels in patients with RMS were no different than those of controls (mean 9.3 vs 9.7 pg/mL respectively; P=1.0).

In ENLIGHTEN patients, early treatment with ozanimod significantly decreased markers of axonal and neuronal damage at 1 year compared with baseline and normalized NfL levels to those of healthy controls, indicating slowed disease activity.
Authors/Disclosures
Sarah Harris
PRESENTER 		Sarah Harris has received personal compensation for serving as an employee of BMS. Sarah Harris has stock in BMS.
Sarah A. Morrow, MD, MSC, FRCPC, FAAN Dr. Morrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono/Merck. Dr. Morrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Morrow 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. Morrow 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. Morrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SanofiGenzyme. Dr. Morrow has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Morrow has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Dr. Morrow has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Dr. Morrow has received research support from Celgene. The institution of Dr. Morrow has received research support from SanofiGenzyme. The institution of Dr. Morrow has received research support from Novartis.
Lauren Shapiro, PhD (BMS) Dr. Shapiro has received personal compensation for serving as an employee of Bristol Myers Squibb.
Aditi Basu Bal, PhD Dr. Bal has nothing to disclose.
Jon Riolo, PhD Dr. Riolo has received personal compensation for serving as an employee of Bristol Myers Squib.