OBJECTIVES: 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. Subsequently, oral edaravone (Radicava ORS®) was FDA-approved in May 2022. The objective of this real-world, observational, US-based administrative claims analysis is to help characterize oral edaravone-treated patients with ALS.

METHODS: Patients with ALS who were continuously enrolled in Optum’s de-identified Clinformatics® Data Mart (CDM) from June 15, 2022, through March 31, 2023, were included and divided into 2 groups: Group 1 initially received IV edaravone and switched to oral edaravone, and Group 2 was edaravone-naïve and received oral edaravone. The index date was the first dosing date of oral edaravone.

RESULTS: Oral edaravone-treated patients with ALS (N=320) consisted of 66 patients in Group 1 and 254 patients in Group 2. Group 1 and Group 2 were predominantly male (54.5% and 57.1%), White (74.2% and 75.6%), and covered by Medicare (68.2% and 66.9%), with a mean±SD age of 61.3±11.8 and 64.6±9.75. The majority of patients in Groups 1 and 2 were concomitantly taking riluzole (93.9% and 83.5%), and 39.4% and 53.1% were taking sodium phenylbutyrate and taurursodiol. The mean±SD treatment durations were 24.3±15.5 months and 3.32±2.62 months, respectively. The percentage of patients in Group 1 and Group 2 who reached the following progression milestones before the index date are listed: Use of canes/walkers/wheelchairs (40.9% and 17.7%), artificial nutrition (33.3% and 16.9%), non-invasive ventilation (39.4% and 20.9%), invasive ventilation (1.5% and 1.6%), hospitalization (34.8% and 26.4%), and gastrostomy tube placement (21.2% and 12.2%).

CONCLUSIONS: This study is ongoing. These real-world data may help clinicians and payers better understand the demographics and clinical characteristics of patients with ALS treated with oral edaravone.