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.