Abstract Details

Title Prognostic Value of Baseline Serum Neurofilament Light Chain Levels in People with Relapsing Multiple Sclerosis by Prior Treatment Status and DMT Type

Topic Multiple Sclerosis

Presentation(s) P5 - Poster Session 5 (8:00 AM-9:00 AM)

Poster/Presentation
Number 1-009

Objective To assess the prognostic value of baseline serum neurofilament light chain (sNfL) levels in treatment-naïve or participants previously treated with disease-modifying therapies (DMTs) before entering ASCLEPIOS I/II.

Background Phase 3 ASCLEPIOS I/II trials in people with relapsing multiple sclerosis (pwRMS), baseline sNfL levels were prognostic for on-study lesion formation in the overall population, recently diagnosed treatment-naive participants, and across subgroups.

Design/Methods

The prognostic value of high (≥9.3 pg/mL) vs low (<9.3 pg/mL) baseline sNfL for the annualized rate of new/enlarging T2 (neT2) lesions was assessed in treatment-naive and previously treated participants by last DMT type prior to study entry (interferon [IFN], glatiramer acetate [GA], dimethyl fumarate [DMF], natalizumab, fingolimod or other MS DMTs (based on investigator’s discretion). The number of neT2 lesions on the last available scan relative to baseline scan was analyzed using a negative binomial model, with time in years between 2 scans as offset. The prognostic value of high vs low sNfL was assessed through lesion rate ratio (RR) attained using this single cut-off.

Results

The adjusted annualized mean rate of neT2 lesions for high vs low baseline sNfL levels was 4.54/2.02 (RR 2.25; P<.001) among previously treated (n [high/low]=483/510) and 3.46/1.60 (RR 2.16; P<.001) among treatment-naive (n=354/331) participants. By DMT type, the annualized rate of neT2 lesions for high/low sNfL was: IFN (n=220/204) 4.48/2.19 (RR 2.05; P<.001); GA (n=123/154) 4.38/1.92 (RR 2.28; P<.001); DMF (n=39/52) 3.32/1.11 (RR 2.98; P=.005); natalizumab (n=27/11) 7.95/2.33 (RR 3.41; P=.058); fingolimod (n=35/40) 4.35/4.43 (RR 0.98; P=.965); and other DMTs (n=38/49) 2.91/0.62 (RR 4.71; P<.001).

Conclusions

Baseline sNfL levels were prognostic for neT2 lesions across previously treated and treatment-naive participants. Amongst previously treated patients, baseline sNfL levels were prognostic for future lesion formation across most DMT types. Results support the use of sNfL as a prognostic biomarker in pwRMS with prior DMT exposure, and untreated pwRMS.

Authors/Disclosures
Eric Thouvenot, MD, PhD (CHU De Nimes - Hopital Caremeau) PRESENTER	Dr. Thouvenot has received personal compensation in the range of $0-$499 for serving as a Consultant for Biogen. Dr. Thouvenot has received personal compensation in the range of $0-$499 for serving as a Consultant for Merck. Dr. Thouvenot has received personal compensation in the range of $0-$499 for serving as a Consultant for Teva. Dr. Thouvenot has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis. Dr. Thouvenot 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. Thouvenot has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Dr. Thouvenot has received research support from Biogen. The institution of Dr. Thouvenot has received research support from Novartis. The institution of Dr. Thouvenot has received research support from Roche.
Stefan Bittner	Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Biogen Idec. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Merck Healthcare. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Novartis. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Roche. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Sanofi. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Bristol-Meyer-Squibbs. Stefan Bittner has received personal compensation in the range of $500-$4,999 for serving as a Honoria with Teva.
Anne H. Cross, MD, FAAN (Washington University School of Medicine)	Dr. Cross has received personal compensation in the range of $500-$4,999 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 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 $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 $500-$4,999 for serving as a Consultant for Sanofi. 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 $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. 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.
Gabriel Pardo, MD, FAAN (Oklahoma Medical Research Foundation)	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 $5,000-$9,999 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 Amgen . 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 $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Pardo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Pardo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Dr. Pardo has or had stock in Progentec Diagnostics.Dr. Pardo has or had stock in Cadenza Bio.
Scott S. Zamvil, MD, PhD, FAAN (University of CA, San Francisco)	Dr. Zamvil has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Zamvil has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Zamvil has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Dr. Zamvil has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. The institution of Dr. Zamvil has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. The institution of Dr. Zamvil has received research support from Sumaira Foundation. Dr. Zamvil has received personal compensation in the range of $5,000-$9,999 for serving as a Advisory Board with Genzyme. Dr. Zamvil has received personal compensation in the range of $500-$4,999 for serving as a Advisory Board with Genentech. Dr. Zamvil has received personal compensation in the range of $500-$4,999 for serving as a Advisory Board with Alexion.
Alit Bhatt	Alit Bhatt has nothing to disclose.
Wenjia Wei	Wenjia Wei has received personal compensation for serving as an employee of Novartis.
Ibolya Boer, MD	Ibolya Boer has received personal compensation for serving as an employee of Novartis AG.
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 Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS . Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 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 TEVA. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Dresden Internation University. 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 BMS. The institution of Dr. Ziemssen has received research support from Roche.

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