Abstract Details

Title Baseline Serum Neurofilament Light Chain Levels Predict Future Disease Activity Irrespective of Race/Ethnicity: Results from the Phase 3 ASCLEPIOS I/II Trials

Topic Multiple Sclerosis

Presentation(s) P9 - Poster Session 9 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-006

Objective

To evaluate the prognostic value of baseline serum neurofilament light chain (sNfL) for future MRI disease activity in diverse racial/ethnic subpopulations (Asian, Black, and Other) of people with relapsing multiple sclerosis (pwRMS) in the Phase 3 ASCLEPIOS I/II trials.

Background In ASCLEPIOS I/II (ofatumumab versus teriflunomide), baseline sNfL levels were prognostic for on-study lesion formation and brain volume loss. However, the prognostic value of sNfL for future disease activity among diverse racial/ethnic subgroups from the trials has yet to be explored.

Design/Methods A baseline sNfL cut-off was predefined by the median sNfL value across the ASCLEPIOS I/II studies and participants were stratified into high (≥9.3 pg/mL) and low (<9.3 pg/mL) groups irrespective of treatment received. The prognostic value of high versus low baseline sNfL for the annualized rate of new/enlarging T2 (neT2) lesions was assessed in the overall population, and Caucasian and racial/ethnic subgroups from ASCLEPIOS I/II. neT2 lesion number on the last available scan (relative to baseline scan) was analyzed using a negative binomial model with time (in years) between the two scans as offset, adjusting for baseline sNfL groups. The prognostic value was assessed via the lesion rate ratio (RR) attained using this single cut-off threshold for high versus low sNfL.

Results Of the 1,882 participants randomized, 1,678 (89.2%) had baseline sNfL and neT2 lesion data available. Annualized mean rate of neT2 lesions for participants with high/low baseline sNfL levels in the Asian (n=31/29), Black (n=29/26), and Other (n=39/34) subgroups were 2.59/0.97 (RR 2.68; p=0.042), 5.10/2.04 (RR 2.50; p=0.061), and 7.79/3.07 (RR 2.54; p=0.029), respectively; values for the Caucasian subgroup (n=738/752) and overall population (n=837/841) were 3.91/1.83 (RR 2.14 p<0.001) and 4.08/1.85 (RR 2.20; p<0.001), respectively.

Conclusions

Baseline sNfL levels were prognostic for neT2 lesion development in all pwRMS, including those of diverse racial/ethnic subpopulations.

Authors/Disclosures
Jason W. Freeman, MD (Novartis Pharmaceuticals, USCDMA) PRESENTER	Dr. Freeman has received personal compensation for serving as an employee of Novartis . Dr. Freeman has stock in Novartis .
Sylvia R. Delgado, MD, FAAN (University of Miami School of Medicine)	The institution of Dr. Delgado has received research support from Novartis. The institution of Dr. Delgado has received research support from EMD Serono.
Enrique Alvarez, MD, PhD (University of Colorado)	Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Alvarez has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene/BMS. The institution of an immediate family member of Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon.
Eric Thouvenot, MD, PhD (CHU De Nimes - Hopital Caremeau)	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.
Annette Okai, MD, FAAN (North Texas Institute of Neurology and Headache)	Dr. Okai has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genentech. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Okai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme . The institution of Dr. Okai has received research support from Sanofi Genzyme. The institution of Dr. Okai has received research support from Roche Genetech. The institution of Dr. Okai has received research support from Novartis. The institution of Dr. Okai has received research support from EMD Serono. The institution of Dr. Okai has received research support from TG Therapeutics.
Alit Bhatt	Alit Bhatt has nothing to disclose.
Wenjia Wei	Wenjia Wei has received personal compensation for serving as an employee of Novartis.
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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