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Abstract Details

Analysis of Reported Deaths While Exposed to Disease-Modifying Therapies for Multiple Sclerosis
Multiple Sclerosis
P6 - Poster Session 6 (12:00 PM-1:00 PM)
9-001

As our armamentarium of DMTs increases, clinical trial data alone is insufficient to evaluate mortality risk.  Data regarding DMT-related deaths exist; however, analysis and stratification of these deaths has not been previously reported.  

To stratify reported deaths while on disease modifying therapy (DMT) for Multiple Sclerosis (MS) based on DMT, year, gender and age.

We queried the Food and Drug Administration Adverse Event Reporting System (FAERS) for all deaths with DMT indication of MS reported through June 30, 2019. We included interferon beta-1a (IFBa), interferon beta-1b (IFBb), glatiramer acetate (GA), dimethyl fumarate (DMF), fingolimod (FIN), teriflunomide (TER), natalizumab (NAT), alemtuzumab (ALE), and ocrelizumab (OCR). We excluded reports where two or more DMTs were the “suspect drug”, or death was from in-utero exposure. Reports were then stratified for each DMT by year, gender, and age.

Total deaths per years approved by FDA in escalating order are ALE (25.4), GA (26.3), TER (45.1), INFb (48.6), FIN (58.8), OCR (63.0), DMF (185.8), NAT (241.8), and INFa (322.4).  Female-to-male ratio in escalating order are OCR (1.24), INFb (1.56), ALE (1.67), FIN (1.74), NAT (1.74), DMF (1.77), GA (1.92), INFa (2.18), and TER (2.3). Analysis of deaths in patients under age 40 was highest for ALE (28.3%), NAT (18.5%), and FIN (18.0%). Deaths for individuals 70 and older was highest for OCR (14.4%), INFa (13.7%), and DMF (13.1%).

Stratification demonstrated, for some DMTs, deaths do not uniformly follow epidemiological data by sex or age distribution. Most notably, female-to-male ratio of 1.24 for OCR compared to 3.5 in the overall MS population, and highest percentage of deaths under 40 was ALE and above 70 was OCR. Annual reported deaths may reflect prescription trends. Our findings call for future studies to examine the relative risk of DMT-related deaths and further stratification by causes of death.

Authors/Disclosures
Sam Hooshmand, DO (Medical College of Wisconsin)
PRESENTER
Dr. Hooshmand has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genetech/Roche. Dr. Hooshmand 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. Hooshmand 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. Hooshmand has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Hooshmand has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Hooshmand has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi.
Nicola Carlisle, MD (The Everett Clinic) No disclosure on file
Chantal Nifle No disclosure on file
Leah Hoffman No disclosure on file
Ahmed Z. Obeidat, MD, PhD (Medical College of Wisconsin ) Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Obeidat has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genentech. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Obeidat has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi/Genzyme . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon pharmaceuticals . Dr. Obeidat has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sandoz. Dr. Obeidat has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Obeidat has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for EMD Serono. Dr. Obeidat has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Banner life sciences . Dr. Obeidat has received personal compensation in the range of $10,000-$49,999 for serving as a Expert opinion and key opinion leader with MJH life sciences . Dr. Obeidat has a non-compensated relationship as a Board member with CMSC that is relevant to AAN interests or activities. Dr. Obeidat has a non-compensated relationship as a Editorial Board Member with IJMSC that is relevant to AAN interests or activities. Dr. Obeidat has a non-compensated relationship as a Reviewer Editor with Frontiers Neurology that is relevant to AAN interests or activities.