好色先生

好色先生

Explore the latest content from across our publications

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Serum Neurofilament Light (sNfL) for Disease Prognosis and Treatment Monitoring in Multiple Sclerosis Patients:Towards Implementation into Clinical Care
Multiple Sclerosis
S26 - MS and CNS Inflammatory Disease: Clinical Considerations II (1:00 PM-1:11 PM)
001

sNfL is associated with disease activity, predicts clinical and imaging outcomes, and is reduced by disease-modifying treatments (DMTs) in RRMS patients. Integration of sNfL into clinical practice requires a standardized validated assay and establishing clinically-meaningful cutpoints.

To define sNfL levels relevant to disease severity stratification and treatment monitoring in relapsing-remitting multiple sclerosis (RRMS) using  Phase III study data. 

sNfL was measured with a SIMOA NF-light® Advantage Kit (Quanterix) or laboratory method in serial samples from >1400 patients in 4 studies. In ADVANCE [peginterferon beta-1a, RRMS, n=859], sNfL was measured at baseline, every 3 months until year 2, then every 6 months until year 4; in CHAMPS [interferon beta 1a (IFNβ1a), clinically isolated syndrome, n=319], at baseline and week 48; in MSCRG (IFNβ1a, RRMS, n=164), at years 3 and 4; and in SENTINEL (natalizumab, RRMS, n=122), at baseline and week 96. Statistical analyses included Spearman correlation, ANOVA, chi-squared test, Kaplan-Meier analysis, and multivariate logistic regression.

Baseline sNfL levels were associated (p<0.0001) with number of enhancing lesions and accumulation of new T2 lesions over time. sNfL>16 pg/mL indicated high probability of disease activity over the following year (PPV=91%); combining multiple sNfL measurements (BL, Months 3 and 6) improved PPV from 91% to 94%. sNfL>16 pg/mL was associated long-term with worse outcomes: EDSS progression (12 years, p<0.05), T2 lesion volume (10 years, p<0.00001), and brain atrophy (5 years p<0.00001). sNfL levels were lowered by DMTs; natalizumab reduced sNfL <16 pg/mL in 96% of patients. Plans for introducing sNfL into clinical practice will also be presented. 

These findings support clinical relevance of sNfL levels and demonstrate feasibility of establishing relevant cut-points for disease severity stratification and treatment monitoring in RRMS patients.  Establishing a standardized, widely accessible assay and validating sNfL in real-world cohorts are essential next steps for implementation of sNfL into clinical practice.

Authors/Disclosures
Peter A. Calabresi, MD, FAAN (Johns Hopkins University)
PRESENTER
Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Calabresi has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia. An immediate family member of Dr. Calabresi has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MyMD. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Myelin Repair Foundation. The institution of Dr. Calabresi has received research support from Genentech. Dr. Calabresi has received publishing royalties from a publication relating to health care. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Grant reveiwer with Myelin Repair Foundation. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker for CME with NYAS. Dr. Calabresi has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Academic CME.
Jens Kuhle, MD Dr. Kuhle has nothing to disclose.
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.
Revere P. Kinkel, MD, FAAN (University of California San Diego) Dr. Kinkel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Kinkel 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. Kinkel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Kinkel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Kinkel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Kinkel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. The institution of Dr. Kinkel has received research support from Department of Defense. The institution of Dr. Kinkel has received research support from PCORI. The institution of Dr. Kinkel has received research support from Sanofi.
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.
No disclosure on file
Dipen P. Sangurdekar, PhD No disclosure on file
Carl DeMoor Carl DeMoor has received personal compensation for serving as an employee of Biogen. Carl DeMoor has received stock or an ownership interest from Biogen. An immediate family member of Carl DeMoor has received personal compensation in the range of $100,000-$499,999 for serving as a Program Director with NIH.
No disclosure on file
No disclosure on file
Aaron Deykin, MD (Biogen Idec) No disclosure on file
Elizabeth Fisher Elizabeth Fisher has received personal compensation for serving as an employee of Biogen. Elizabeth Fisher has stock in Biogen. Elizabeth Fisher has received intellectual property interests from a discovery or technology relating to health care.
Alfred W. Sandrock, MD, PhD (Biogen) No disclosure on file
Bernd C. Kieseier, MD (Novartis) Dr. Kieseier has received personal compensation for serving as an employee of Novartis. Dr. Kieseier has stock in Novartis.
Richard A. Rudick, MD, FAAN (Optimal Brain Health Consultants) Dr. Rudick has received personal compensation for serving as an employee of Biogen. Dr. Rudick has received stock or an ownership interest from Biogen. Dr. Rudick has received publishing royalties from a publication relating to health care.
Tatiana Plavina, PhD No disclosure on file