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Abstract Details

Spinal Cord Area Correlates with Disability and Quality of Life in Progressive MS: A Baseline MRI Analysis from the SPI2 Phase 3 Trial of MD1003 (high dose Pharmaceutical grade Biotin)
Multiple Sclerosis
P15 - Poster Session 15 (12:00 PM-1:00 PM)
9-001
Correlate clinical disability measures with brain and spinal cord MRI findings at baseline in SPI2.
In cross-sectional studies, spinal cord areas strongly correlate with MS disability. Phase-sensitive inversion recovery (PSIR) spinal cord imaging is an exploratory endpoint of SPI2, a Ph3 trial investigating the efficacy and safety of MD1003 (high dose Pharmaceutical grade Biotin) in progressive MS.
Brain and spinal cord MRI scans were acquired at 50 centers having the necessary capabilities. MRI sequences acquired at baseline were: brain T1/T2-weighted, Gd+, and PSIR at vertebral levels C2-3/C3-4. Univariate spearman correlations (SC) and LASSO subset selection multiple regression (MR) models were used to predict clinical metrics (EDSS, T25FW: Timed 25-foot walk, SDMT: Single Digit Modality Test, and MSQoL-29 PHCS/PH: Physical health composite score/item) from MRI metrics (nTCA: total cord areas, nBV: brain volume, nGMV: cortical grey matter volume, T1/T2LV: T1/T2 lesion volumes, nTHV: thalamic volume; “n”=normalized), sex, age, onset age, and disease course.
As of October 20th, 2019, baseline brain and cervical spinal cord MRI scans were available for 140 primary and 234 secondary progressive MS (PPMS, SPMS) participants. EDSS-significant SCs were nTCA p<0.0001, nBV p=0.011, T1LV p=0.014; LASSO MR gave nTCA p=0.0014, T1LV p=0.015. T25FW-significant SCs were nTCA p<0.0001, nBV p<0.0002, T1LV p=0.0032, nGMV p=0.018; LASSO MR gave nTCA p<0.0001, nBV p=0.046, T1LV p=0.055. All MRI metrics were correlated with SDMT in SCs (p<0.0001) except for nTCA; LASSO MR gave nBV and T1LV (both p<0.0001). LASSO MR with MSQoL-29 PH gave only nTCA.

This is the first successful deployment of cross-platform, PSIR spinal cord imaging in an MS randomized controlled trial. Total cord areas correlated with clinical disability (EDSS, T25FW) in progressive MS patients enrolled in SPI2. Total cord areas may serve as a correlate of clinical disability, either alone or with brain MRI metrics.
Authors/Disclosures
Amber M. Alexander
PRESENTER 		Amber M. Alexander has nothing to disclose.
Valerie A. Block, DPTSc (University of California, San Francisco) Dr. Block has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Block has received research support from National MS Society.
Nico Papinutto No disclosure on file
No disclosure on file
No disclosure on file
Douglas L. Arnold, MD, FÂ鶹´«Ã½Ó³»­ (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.
Frederic Sedel No disclosure on file
Bruce A. Cree, MD, PhD, MAS, FÂ鶹´«Ã½Ó³»­ (UCSF, Multiple Sclerosis Center) The institution of Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuron23. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal/Sandoz. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. The institution of Dr. Cree has received research support from Genentech. The institution of Dr. Cree has received research support from Kyverna. Dr. Cree has received publishing royalties from a publication relating to health care.
Roland G. Henry, PhD (University of California, San Francisco) Dr. Henry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MEDDAY. Dr. Henry 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. Henry has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Henry has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi/Genzyme.