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Abstract Details

Prognostic Value of Serum NfL for Subclinical Disease Activity and Worsening in Patients with RMS: Results from the Phase 3 ASCLEPIOS I and II Trials
Multiple Sclerosis
MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)
088
To confirm the prognostic value of baseline serum neurofilament (sNfL) for brain lesion formation and volume change (VC) on MRI in relapsing MS patients, and investigate the relationship of sNfL with regional brain VC.
In the Phase 3 ASCLEPIOS I/II trials, ofatumumab significantly lowered sNfL from the first assessment at Month (M)3 to M24 versus teriflunomide, while whole brain (WB) VC was not significantly different.
In this pre-planned pooled ASCLEPIOS I/II analysis (N=1882), patients were stratified by median baseline sNfL levels (9.3 pg/mL) into high (>median) and low (≤median) categories to assess prognostic value of sNfL on: annual rate of new/enlarging T2 (neT2) in Year 1 and 2, and annual percentage VC in WB, cortical grey matter (cGM), white matter (WM), and thalamus. Pearson correlation coefficients between baseline sNfL and regional brain VC at M12 were analyzed.
High baseline sNfL (vs low) was prognostic of increased on-study neT2 lesion formation in Year 1 (adjusted mean annual rate: ofatumumab 1.48 vs 0.57, +158%, p<0.001; teriflunomide 5.49 vs 3.26, +69%, p<0.001) and 2 (ofatumumab 0.09 vs 0.06, +65%, p=0.124; teriflunomide 4.53 vs 3.12, +46%, p=0.003). High baseline sNfL (vs low) was prognostic of higher annual percentage VC in WB (ofatumumab −0.32% vs −0.23%, p=0.045 and teriflunomide −0.43% vs −0.29%, p=0.001), WM (−0.30% vs −0.18%, p=0.049 and −0.37% vs −0.17%, p=0.002), and thalamus (−0.49% vs −0.29%, p=0.092 and −0.94% vs −0.53%, p=0.001), but not cGM VC (−0.36% vs −0.32%, p=0.514 and −0.51% vs −0.48%, p=0.641). Baseline sNfL was correlated with thalamic (ofatumumab r=−0.374, p<0.0001 and teriflunomide r=−0.308, p<0.0001) and WM (r=−0.230, p<0.0001 and r=−0.207, p<0.0001) VC, and less with cGM VC (r=−0.026, p=0.4679 and r=−0.070, p=0.0523).
Baseline sNfL levels are prognostic of on-study lesion formation and WB, WM, and thalamus VC, but not cGM. Baseline sNfL has the strongest correlation with thalamic VC.
Authors/Disclosures
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden)
PRESENTER 		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.
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 received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Clario.
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.
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.
Roman Willi, PhD (Novartis Pharma AG) Dr. Willi has received personal compensation for serving as an employee of Novartis Pharma. Dr. Willi has received stock or an ownership interest from Novartis.
Bingbing Li Bingbing Li has received personal compensation for serving as an employee of Novartis.
No disclosure on file
Harald Kropshofer Harald Kropshofer has nothing to disclose.
Krishnan Ramanathan Krishnan Ramanathan has received personal compensation for serving as an employee of Novartis.
Martin Merschhemke No disclosure on file
Wendy Su, PhD No disclosure on file
Dieter Haering Dieter Haering has received personal compensation for serving as an employee of Novartis.
Stephen L. Hauser, MD (UCSF Weill Institute for Neurosciences) Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NGM Bio. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pheno Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nurix Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gilead. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Accure. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alector. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hinge Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Neurona. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Roche that is relevant to AAN interests or activities. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Novartis that is relevant to AAN interests or activities.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel) Dr. Kappos has nothing to disclose.
Jens Kuhle, MD Dr. Kuhle has nothing to disclose.