Real-World Evidence of Radicava® (edaravone) for Amyotrophic Lateral Sclerosis From a National Infusion Center Database in the United States


Real World Data - Disease registries, natural history, post marketing surveillance

Poster Number: 163


Terry Heiman-Patterson, MD, Johnna Perdrizet, MPH, Barbara Prosser, Wendy Agnese, PharmD, Stephen Apple, MD


1. Temple University Lewis Katz School of Medicine, Philadelphia, PA, USA, 2. Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ, 3. Soleo Health, McKinney, TX, 4. Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ, 5. Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ, USA

Background: Radicava® (edaravone) became available to US health care providers in August 2017. A pivotal, randomized, controlled clinical study conducted in Japan showed that edaravone slowed the rate of functional loss in ALS. Radicava® is administered by infusion at clinic sites, infusion centers, or at home. As 1 of only 2 drug therapies approved for the treatment of ALS in the US, and because the pivotal clinical studies for edaravone were conducted in Japan, there is interest in the real-world experience with Radicava®. However, to date, real-world evidence (RWE) on the use of Radicava® in the US has been lacking.

Objective: To provide RWE of Radicava® collected by a provider of home and alternative-site infusions.

Approach: A provider of home and alternative-site infusions and specialty pharmacy services in the US, Soleo Health, collected a database of RWE on the use of Radicava® through its SoleMetrics® clinical outcomes program. A retrospective analysis of this database was conducted, which included data from 167 ALS patients receiving Radicava® for at least 3 months.

Results: The patients receiving Radicava® had a mean age of 60 years. The patients had been using Radicava® for a median of 332 days per patient. Changes in ALS Functional Rating Scale-Revised (ALSFRS-R) score during the analysis period averaged approximately −0.62 units per month. Review of safety data was not inconsistent with the clinical trials. The limitations stemming from voluntary reporting and occasional missing information should be considered when interpreting these results.
Conclusions: The data from this RWE report may be helpful for clinicians who are considering using Radicava® therapy with their ALS patients.