Radicava delays time to certain ALS disease progression milestones
Use of medication also prolonged patients' survival over two years
It takes longer for people with amyotrophic lateral sclerosis (ALS) who are being treated with Radicava (edaravone) to reach certain disease progression milestones, such as using a walking aid or a wheelchair, compared with those not treated with the medication.
A study of real-world data also indicates the proportion of patients on Radicava who died over two years (43%) was also nearly halved compared with the proportion of deaths in the control group (75.9%).
“These data reinforce the utility of Radicava and build upon the growing evidence that expands our knowledge of edaravone in ALS,” Gustavo A. Suarez Zambrano, MD, vice president of medical affairs at Mitsubishi Tanabe Pharma America (MTPA), which markets Radicava in the U.S., said in a company press release.
The study, “Longer disease progression milestone-free time in people with amyotrophic lateral sclerosis treated versus not treated with intravenous edaravone: results from an administrative claims analysis,” was published as a short report in the Journal of Comparative Effectiveness Research. Part of its data were presented previously at a medical meeting.
Radicava is an approved ALS treatment that acts as an antioxidant, neutralizing the toxic oxidative molecules produced during normal cellular metabolism and that damage nerve cells.
It was first approved as an intravenous (IV), or into-a-vein, injection lasting one hour and it’s now also available for the same indication as Radicava ORS, an oral suspension that’s intended to be more convenient to patients.
While both formulations have slowed disease progression in clinical trials and real-world settings, “by continuing to study Radicava in both its IV and oral suspension forms, we aim to expand our understanding of the medication and its limitations to better support the ALS community,” Zambrano said.
Radicava on disease progression, survival
Here, researchers at MTPA and other institutions drew on data from a large U.S. health insurance database of about 17-19 million people with commercial insurance or Medicare Advantage plans. Based on insurance claims, the researchers found 15,099 adults with ALS between August 2017 and December 2021, 423 of whom had received Radicava during that period.
To make direct comparisons, the researchers matched each person who received Radicava to one other ALS patient who hadn’t received it, but was similar in age, sex, race, region of residence, disease duration, insurance type, and treatment with riluzole. Other factors, such as if patients had claims for cardiovascular disease, nutritional support, noninvasive ventilation, or hospitalization, were also taken into account for matching. In the end, researchers compared 395 ALS patients who’d been given Radicava against 395 matched controls.
Restricted mean time lost (RMTL), a measure of the average amount of time patients lose as they reach a disease milestone, was calculated for six disease progression milestones, including using a cane/walker/wheelchair, artificial nutrition, noninvasive or invasive ventilation, speech-generating devices, and hospice care.
Over up to 24 months, the patients were treated with Radicava for a median of 7.5 months. Compared with people who didn’t receive it, RMTL scores were significantly lower among Radicava-treated patients across four milestones, meaning these patients lost a smaller amount of time due to reaching disease progression milestones. In particular, patients who used Radicava had significantly longer milestone-free survival for new use of a walking aid or wheelchair, artificial nutrition, noninvasive ventilation, and speech-generating devices.
Data also showed that a greater proportion of patients treated with Radicava reached no milestone over two years (42.3% vs. 33.9%). Moreover, there were nearly half as many deaths among patients treated with Radicava than among those who didn’t receive the treatment (43% vs. 75.9%).
While the study only included patients with private healthcare insurance or Medicare Advantage coverage, “real-world evidence like this can supplement data from randomized controlled trials and offer additional insights into how treatments like [Radicava] may impact disease progression,” said James D. Berry, MD, study lead author and director of the multidisciplinary ALS clinic at Massachusetts General Hospital in Boston.
“Due to the small amount of data in the ALS field regarding time-to-milestone progression, the current study helps to fill the knowledge gap by providing [real-world data] on the general timing to milestones,” the researchers wrote.
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