Details of Item-Level Analysis of Aducanumab at AAN 2022: Sharon Cohen, MD, FRCPC

WATCH TIME: 6 minutes

"What we want to know at the end of the day is: is there one domain or one item or group of items that’s driving the effect? Is the drug better for certain clinical profile than for others? Or, how believable is the response? If memory is responding, but visual spatial function judgement problem solving are not, does it make any sense? The item-level analysis was to shed more light on the individual domains and items in the test."

In June 2021, the FDA approved Biogen’s investigational antiamyloid disease-modifying agent aducanumab (Aduhelm) for the treatment of Alzheimer disease, marking it as the first novel approval for the neurodegenerative condition since 2003.¹ The landmark decision came coupled with concern from the medical community over the consistency of the data from its late-stage development program. To counteract some of this, the medication was approved under the accelerated approval pathway, which will require Biogen to conduct post-approval phase 4 studies to confirm the benefit of the drug.

Biogen has already begun some of those efforts, and most recently, had data presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington. Led by Sharon Cohen, MD, FRCPC, the group of investigators conducted an analysis of the pivotal phase 3 EMERGE study (NCT02484547) to examine change from baseline item-level scores in primary, secondary, and tertiary clinical end points. EMERGE was one of 2 phase 3 clinical trials used to support aducanumab’s biologics license application.

At the end of the 78-week treatment period, aducanumab’s treatment effects were observed across all Clinical Dementia Rating–Sum of Boxes score domains, the primary end point. Overall, aducanumab appeared to have positive impacts across a broad array of cognitive, functional, and neuropsychiatric measures.² Cohen, a neurologist and assistant professor at the University of Toronto, sat down with NeurologyLive® to break down the results in detail, as well as why she feels these data reflects the perspectives of patients, caregivers, and clinicians.

Click here for more coverage of AAN 2022.

REFERENCES
1. FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. News release. FDA. June 7, 20121. Accessed April 19, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

2. Cohen S, He P, Benea ML, et al. Item-level analysis of clinical measures in patients with early symptomatic Alzheimer’s disease following treatment with high-dose aducanumab in the phase 3 EMERGE study. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Poster 1386