Real-world safety of the novel, free radical scavenger edaravone for amyotrophic lateral sclerosis patients: Data from the post-marketing surveillance SUNRISE Japan

Background: Treatment options for amyotrophic lateral sclerosis (ALS) are limited. SUNRISE Japan is an ongoing post-marketing surveillance evaluating the long-term efficacy and safety of edaravone, a novel neuroprotectant agent, and free radical scavenger, in patients with ALS. Aim: This study aims to describe the real-word safety results of ALS patients enrolled in SUNRISE Japan. Methods: Patients diagnosed with ALS and prescribed edaravone for the first time during the surveillance period were included. Patients were prescribed edaravone according to the prescribing information. The incidence of adverse drug reactions (ADRs) reported up to 1 year of follow-up was evaluated. Results: Of 805 patients enrolled up to April 2020, 800 were included in the safety analysis set. Patients had a mean age of 66.3 years, 55.1% were male, and they had a mean disease duration of 1.8 years. In total, 97 patients (12.1%) reported at least one ADR, with a total of 148 ADR events reported. Thirty patients (3.8%) reported at least one serious ADR with a total of 42 serious ADR events reported. Hepatic function abnormal was the most frequently reported ADR, with an incidence of 4.4% (35/800). A higher incidence of ADRs was observed in patients with percent forced vital capacity >= 80%, and those with previous/concomitant treatment with riluzole. Conclusion: In this surveillance study, hepatic ADRs were the most frequently reported events. These ADRs have also been reported previously in patients receiving standard therapy. No new safety concerns were raised with real-world use of edaravone.