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: