Abstract Details

Title Investigating the Correlation Between Serum Neurofilament Light Chain (sNfL) Concentration and Magnetic Resonance Imaging (MRI)-Outcomes in Patients With a First Clinical Demyelinating Event in the REFLEX Trial

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 005

Objective Post-hoc assessment of correlation between sNfL concentration and MRI-outcomes in patients with a first clinical demyelinating event in REFLEX.

Background

sNfL has been characterized as a biomarker of disease activity, prognosis and treatment response in patients with multiple sclerosis (MS).

Design/Methods Patients were randomized to subcutaneous interferon-beta-1a (scIFNβ-1a) once- (ow; n=175) or three-times-weekly (tiw; n=171), or placebo (n=171) over 24 months; those who converted to clinically definite MS switched to open-label scIFNβ-1a tiw. sNfL levels were analyzed at baseline, month 6, month 12 and month 24; patients with sNfL data at baseline and ≥1 post-baseline time-point were included. The correlations between month 24 sNfL levels and MRI-outcomes at month 24 were assessed by Spearman’s rank correlation coefficient (r; p<0.001 for all numerical correlations described). Correlation analyses were performed on observed data; number of observations per outcome is reported.

Results In the placebo group, month 24 sNfL concentration strongly correlated with mean number of new T2 (r=0.72), combined unique active (CUA; r=0.70) and new gadolinium-enhancing (r=0.60) lesions and moderately correlated with new T1-hypointense lesions (r=0.49) per-patient-per-scan at month 24 (all n=91). sNfL concentration also moderately correlated with total T2 lesion volume (r=0.45) at month 24 (n=133). Except for moderate correlations with mean number of new T2 (r=0.46), CUA (r=0.49), new T1-hypointense (r=0.48) and new gadolinium-enhancing (r=0.40) lesions per-patient-per-scan in the scIFNβ-1a ow group (all n=113), there were weak correlations between sNfL levels and the majority of the MRI-outcomes (r=0.11-0.37) reported for patients treated with scIFNβ-1a tiw/ow.

Conclusions

At month 24 in REFLEX, sNfL levels correlated with several brain MRI measures of disease activity in the placebo group. Correlations with MRI-outcomes at month 24 were weaker in the scIFNβ-1a tiw/ow groups, since both the sNfL levels and the number of CUA lesions were lower compared with placebo at this time-point.

Authors/Disclosures
Jens Kuhle, MD PRESENTER	Dr. Kuhle has nothing to disclose.
David Leppert, MD (University Hospital Basel)	Dr. Leppert has received personal compensation for serving as an employee of GeNeuro. Dr. Leppert has received personal compensation for serving as an employee of GeNeuro. Dr. Leppert has received personal compensation for serving as an employee of Geneuro. Dr. Leppert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Leppert has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Leppert has received personal compensation in the range of $0-$499 for serving as a Consultant for Orion. Dr. Leppert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Leppert has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quanterix. Dr. Leppert has stock in Novartis.
	No disclosure on file
Nicola De Stefano, MD (University of Siena)	Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Healthcare KGaA. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharma AG. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Serono S.p.A. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. De Stefano has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche S.p.A.. The institution of Dr. De Stefano has received research support from Italian MS Society. The institution of Dr. De Stefano has received research support from Merck Healthcare KGaA.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
Mark S. Freedman, MD, FAAN (University of Ottawa)	Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion(Janssen/J&J). Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiogenIdec. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS/Celgene. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Inc. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion (Janssen/J&J). Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Atara Biotherapeutics. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer Healthcare. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BiogenIdec. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Nanomedicine. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRI Bio. Dr. Freedman 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. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Magenta Therapeutics. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Freedman 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. Freedman 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 Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Freedman has received research support from Sanofi Genzyme.
	No disclosure on file
Sanjeev Roy	Sanjeev Roy has received personal compensation for serving as an employee of Merck KgGA.

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