Abstract Details

Title Real-world Evidence of Radicava® (Edaravone) for Amyotrophic Lateral Sclerosis from a National Infusion Center Database in the United States

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) S35 - Amyotrophic Lateral Sclerosis (5:18 PM-5:30 PM)

Poster/Presentation
Number 010

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

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.

Design/Methods 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 are expected to be helpful for clinicians who are considering using Radicava® therapy with their ALS patients.

Authors/Disclosures
Terry D. Heiman-Patterson, MD (Temple University Lewis Katz School of Medicine) PRESENTER	Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MTPA. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amylyx. Dr. Heiman-Patterson has received personal compensation in the range of $0-$499 for serving as a Consultant for novartis. Dr. Heiman-Patterson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for biogen. The institution of Dr. Heiman-Patterson has received research support from MTPA. The institution of Dr. Heiman-Patterson has received research support from State of Pennsylvania . The institution of Dr. Heiman-Patterson has received research support from ALS Association. The institution of Dr. Heiman-Patterson has received research support from ALS United. The institution of Dr. Heiman-Patterson has received research support from ALS Hope Foundation.
	No disclosure on file
	No disclosure on file
Wendy Agnese	No disclosure on file
Stephen Apple	Stephen Apple has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America, Inc.

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