Abstract Details

Title A Preliminary Analysis of Oral Edaravone-treated Patients with Amyotrophic Lateral Sclerosis Enrolled in a US-based Administrative Claims Database

Topic General Neurology

Presentation(s) S3 - General Neurology 1 (1:48 PM-2:00 PM)

Poster/Presentation
Number 005

Objective To characterize oral edaravone-treated patients with ALS in this observational, US-based administrative claims analysis.

Background Intravenous (IV) edaravone (Radicava®) was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of amyotrophic lateral sclerosis (ALS) and was shown in clinical trials to slow the rate of physical functional decline. Oral edaravone (Radicava ORS®) was FDA-approved for use in patients with ALS in May 2022.

Design/Methods Patients with ALS who were continuously enrolled in Optum’s de-identified Clinformatics® Data Mart (CDM) from June 15, 2022, through December 31, 2022, were divided into 2 groups. Group 1 initially received IV edaravone and switched to oral edaravone. Group 2 received oral edaravone and was previously edaravone-naïve. The index date was the first oral edaravone dosing date.

Results Oral edaravone-treated patients with ALS (n=231) consisted of Group 1 (n=59) and Group 2 (n=172). Group 1 and Group 2 were predominantly male, White, and covered by Medicare, with a mean±SD age of 61.3±11.8 and 63.9±10.1, respectively. The majority of patients in Groups 1 and 2 were concomitantly taking riluzole (93.2% and 83.1%), and 11.9% and 23.3% were concomitantly taking sodium phenylbutyrate and taurursodiol, respectively. The mean±SD treatment duration was 22.4±15.7 months for Group 1 and 2.6±1.9 months for Group 2. Patients in Groups 1 and 2 who reached the following pre-index progression milestones are listed: Use of canes/walkers/wheelchairs (37.3% and 22.1%), artificial nutrition (27.1% and 16.9%), non-invasive ventilation (37.3% and 23.3%), invasive ventilation (1.7% and 2.3%), hospitalization (37.3% and 27.9%), and gastrostomy tube placement (15.3% and 11.0%).

Conclusions

Additional results are expected in this ongoing study. The real-world data in this study may help clinicians and payers better understand the demographics and clinical characteristics of oral edaravone-treated patients with ALS.

Sponsorship: This study was sponsored by Mitsubishi Tanabe Pharma America, Inc.

Authors/Disclosures
Malgorzata Ciepielewska PRESENTER	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.
Polina Da Silva, Other (Mitsubishi Tanabe Pharma America)	Mrs. Da Silva has nothing to disclose.

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