The following is an excerpt from Medpage Today.
A man treated with the recently approved Alzheimer’s drug aducanumab (Aduhelm) had six amyloid-related imaging abnormality (ARIA) episodes, researchers reported.
Over 44 months in a long-term extension study, the Alzheimer’s disease patient had recurrent episodes of asymptomatic mild or moderate ARIA-edema (ARIA-E), with one episode including mild ARIA-hemorrhage (ARIA-H) with mild superficial siderosis, noted Jacob Hall, MD, of the Neurology Center of Southern California in Temecula, and co-authors in a letter published in JAMA Neurology.
Brain abnormalities like vasogenic edema and cerebral microhemorrhage were first observed on MRI in trials of a monoclonal antibody against amyloid-beta over a decade ago and have since been associated with other amyloid-modifying therapies, including aducanumab.
Since its controversial approval on June 7, aducanumab has had a slow uptake in the Alzheimer’s field, with some people questioning not only the drug’s efficacy, but its adverse effects. In phase III clinical trials, ARIA-E or ARIA-H occurred in roughly 40% of participants in high-dose aducanumab groups.
Details about the aducanumab phase III trials and adverse events have not yet been published in a peer-reviewed journal, but ARIA-E episodes generally resolved in 4 to 16 weeks, and most patients with ARIA continued in the studies, drug maker Biogen said.
Note: In May 2021, I featured a cover story on Full Measure, examining the controversy surrounding the aducanumab clinical trials conducted by Biogen, and the FDA’s willingness to accept allegedly inconclusive and incomplete data.
Watch Full Measure story Mind Game
