Findings from the review, “Safety and Efficacy of Edaravone in Delaying Functional Decline in Amyotrophic Lateral Sclerosis: A Meta-Analysis,” were presented in a poster session at the 2019 American Academy of Neurology (AAN) annual meeting, taking place through May 10 in Philadelphia.
Radicava is a free radical scavenger, meaning it removes molecules called free radicals. Free radicals are produced by the normal processes of cells but can also cause damage. These molecules are a toxic byproduct of normal cellular function, and are thought to be one of the reasons nerve cells die in ALS, which is why removing them might have clinical benefits.
Researchers from the University of the Philippines conducted a meta-analysis (a systematic review of the available peer-reviewed scientific literature) of studies in which ALS patients were treated with either Radicava — 60 mg injected into the bloodstream every month — or a placebo. They identified three such studies that included a total of 368 ALS patients.
In all studies, the rates of adverse side effects (both serious and non-serious) were similar in both the Radicava-treated and placebo-treated groups, which suggests the relative safety of the treatment.
The mean change in the patients’ ALS Functional Rating Scale Revised (ALSFRS-R) scores — a measurement of the severity of ALS — were higher in the placebo group than in the radicava-treated group after 24 weeks of treatment. Such change indicates greater functional deterioration, so the results suggest that Radicava treatment may slow the rate at which ALS causes functional changes.
However, mortality was not different between the two groups, meaning there was no evidence that Radicava had an effect on how long patients lived.
The researchers did note that the results of the three studies were pretty heterogenous — that is, the precise results differed significantly among the three studies. This makes it hard to say with certainty, for example, whether some patients might benefit more from Radicava treatment than others, or what the exact rate of response to be expected is. Further studies with larger patient populations may help to shed light on these remaining questions.