Abstract Details

Title Continued Intravenous Edaravone Treatment in Patients with Amyotrophic Lateral Sclerosis (ALS) Increases Overall Survival Compared With No Intravenous Edaravone Treatment: Results from a US Administrative Claims Database

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P2 - Poster Session 2 (11:45 AM-12:45 PM)

Poster/Presentation
Number 11-004

Objective To evaluate overall survival in patients with ALS treated with intravenous (IV) edaravone compared with those who were not treated with IV edaravone.

Background IV edaravone received approval from the US Food and Drug Administration in May 2017 based on a 33% (P=.0013) slowing of functional loss, as measured by the ALS Functional Rating Scale-Revised compared with placebo at 24 weeks.

Design/Methods The analysis included patients with ALS who initiated treatment with IV edaravone between 08/08/2017, and 03/31/2020, and enrolled in Optum’s de-identified Clinformatics® Data Mart database. Propensity score matching (1:1) identified IV edaravone–treated patients (cases) and non–edaravone-treated patients (controls) matched for covariates potentially affecting survival: age, race, geographic region, gender, pre-index disease duration (defined as the period between the date of first claim for ALS diagnosis and the first claim for IV edaravone), insurance, history of cardiovascular disease, riluzole prescription, gastrostomy tube placement, artificial nutrition, non-invasive ventilation, and all-cause hospitalization. For cases, the index date was the date of the first claim for IV edaravone. For controls, the index date was the date IV edaravone was available on the market (August 2017). Shared frailty Cox regression analysis was performed to estimate the bene?t of IV edaravone.

Results In total, 318 cases were matched to 318 controls. In both groups, 208 patients (65.4%) had a history of riluzole prescription. As of 03/31/2021, there were 155 deaths (48.7%) among the cases and 196 among the controls (61.6%). Median overall survival was 29.5 months and 23.5 months, respectively, and the risk of death was 27% lower among cases vs controls (HR: 0.73; 95% CI: 0.59-0.91; P=0.005).

Conclusions This real-world analysis demonstrated that continued IV edaravone treatment, in a large predominantly riluzole-treated US cohort, is associated with improved overall survival compared with not using IV edaravone.

Authors/Disclosures
Benjamin R. Brooks, MD, FAAN (Clinical Trials Planning LLC) PRESENTER	Dr. Brooks has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe Pharma America. Dr. Brooks has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medicinova. Dr. Brooks has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Brooks has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AB Science. Dr. Brooks has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Ionis. Dr. Brooks has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Mitsubishi Tanabe Pharma America. The institution of Dr. Brooks has received research support from Mitsubishi TanabePharma America. Dr. Brooks has received personal compensation in the range of $0-$499 for serving as a Member Annual Surveillance Committee CDC National ALS Registry with Center for Disease Control Agency Toxic Substances Disease Registry. Dr. Brooks has a non-compensated relationship as a Member ALS Quality Measures Subcommittee with ��ɫ�� that is relevant to AAN interests or activities.
James D. Berry, MD MPH (Massachusetts General Hospital)	Dr. Berry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Berry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clene Nanomedicine. Dr. Berry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MT Pharma Holdings of America. Dr. Berry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Regeneron. Dr. Berry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MTPA. Dr. Berry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Berry has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Berry has stock in ReactNeuro. The institution of Dr. Berry has received research support from Biogen. The institution of Dr. Berry has received research support from MT Pharma of America. The institution of Dr. Berry has received research support from Rapa Therapeutics. The institution of Dr. Berry has received research support from Brainstorm Cell Therapeutics. The institution of Dr. Berry has received research support from Alexion. The institution of Dr. Berry has received research support from nQ Medical. The institution of Dr. Berry has received research support from ALSA. The institution of Dr. Berry has received research support from MDA. The institution of Dr. Berry has received research support from Amylyx. The institution of Dr. Berry has received research support from Transposon. Dr. Berry has a non-compensated relationship as a Scientific Advisor with Everything ALS that is relevant to AAN interests or activities.
Malgorzata Ciepielewska	Malgorzata Ciepielewska has received personal compensation for serving as an employee of Mitsubishi Tanable Pharma America, Inc..
Jeffrey Zhang (Princeton Pharmatech LLC.)	The institution of Jeffrey Zhang has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BioVie.
Ying Liu	Ying Liu has nothing to disclose.
Gustavo A. Suarez-Zambrano, MD	Dr. Suarez-Zambrano has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America.
Melissa Hagan (Mitsubishi Tanabe Pharma America, Inc)	Melissa Hagan has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America, Inc..

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