Background: Intravenous (IV) edaravone (Radicava®) was authorized by Health Canada in October 2018 for the treatment of ALS and was shown in clinical trials to slow the rate of functional loss associated with ALS. In Canada, the MTP-Patient Support® (MTP-PS) program offers patient support services and is collecting real-world data from edaravone-treated patients with amyotrophic lateral sclerosis (ALS).
Objectives: To determine real-world treatment retention, safety, and tolerability from edaravone-treated patients with ALS in the MTP-PS program.
Results: This ongoing, observational, real-world study is collecting de-identified data from edaravone-treated patients enrolled in the MTP-PS program for up to 4 years with 4 pre-planned analyses. The Full Analysis Set (FAS) includes edaravone-naïve (Naïve Analysis Set [NAS], patients with no prior edaravone treatment) and edaravone-experienced (Experienced Analysis Set [EAS], patients with prior edaravone treatment) patients. Baseline demographics are assessed at edaravone initiation. This analysis included 616 FAS patients, of which 73% (n=452) were edaravone-naïve. The edaravone-naïve patients were predominantly >55 years old (78%) and male (62%). Most patients had limb-onset ALS (67%) and definite or probable ALS (65%). Most patients (78%) initiated IV edaravone within <6 months of ALS diagnosis and had previous treatment with riluzole (60%). IV edaravone was administered at an infusion clinic for 30% of patients. Patients in the NAS had a mean total ALS Functional Rating Scale-Revised score of 42.1 and a mean forced vital capacity score of 95.8%. Patient retention rate on edaravone was 56.2% and 27.0% for 12 and 24 months, respectively. Conclusions: This study currently offers insight into real-world demographics and characteristics of edaravone-treated patients in Canada. Next steps are to evaluate real-world treatment retention, safety, and tolerability of edaravone-treated patients as the study progresses. The real-world evidence generated may be valuable for informing clinicians and payers and enhancing patient support services. Sponsorship: This study was sponsored by MTP-CA