Browsing by Subject "aducanumab"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Aducanumab: Appropriate Use Recommendations Update
    (Springer, 2022-04-05) Cummings, Jeffrey; Rabinovici, G. D.; Atri, A.; Aisen, P.; Apostolova, L. G.; Hendrix, S.; Sabbagh, M.; Selkoe, D.; Weiner, M.; Salloway, S.; Alzheimer’s Disease and Related Disorders Therapeutics Working Group; Neurology, School of Medicine
    Aducanumab (Aduhelm) is approved in the United States for the treatment of patients with mild cognitive impairment due to Alzheimer’s disease or mild AD dementia. Aducanumab Appropriate Use Recommendations (AURs) have been published and have helped guide best practices for use of aducanumab. As real-world use has occurred and more information has accrued, the AURs require refinement. We update the AURs to better inform appropriate patient selection and improve shared decision-making, safety monitoring, and risk mitigation in treated patients. Based on evolving experience we emphasize the importance of detecting past medical conditions that may predispose to amyloid related imaging abnormalities (ARIA) or may increase the likelihood of ARIA complications including autoimmune or inflammatory conditions, seizures, or disorders associated with extensive white matter pathology. The apolipoprotein E ε4 (APOE4) genotype is strongly associated with ARIA and exhibits a gene dose effect. We recommend that clinicians perform APOE genotyping to better inform patient care decisions, discussions regarding risk, and clinician vigilance concerning ARIA. As most ARIA occurs during the titration period of aducanumab, we suggest performing MRI before the 5th, 7th, 9th, and 12th infusions to improve detection. Uncommonly, ARIA may be recurrent or serious; we suggest additional parameters for treatment discontinuation taking these observations into account. It is important to continue to learn from the real-world use of aducanumab and the AURs will continue to evolve as new information becomes available. This AUR update does not address efficacy, price, or insurance coverage and is provided to assist clinicians to establish best practices for use of aducanumab in the treatment of patients with mild cognitive impairment and mild Alzheimer’s dementia.
  • Thumbnail Image
    Item
    How Will Aducanumab Approval Impact AD Research?
    (Springer, 2021-07-22) Weiner, Michael W.; Aisen, P. S.; Beckett, L. A.; Green, R. C.; Jagust, W.; Morris, J. C.; Okonkwo, O.; Perrin, R. J.; Petersen, R. C.; Rivera Mindt, M.; Saykin, A. J.; Shaw, L. M.; Toga, A. W.; Trojanowski, J. Q.; Medical and Molecular Genetics, School of Medicine
    The accelerated approval of aducanumab (AduhelmTM) by the US FDA is a momentous event. For the first time, a therapeutic agent that targets the neurobiology of Alzheimer’s disease (AD) is available for clinical use (1, 2). In addition to the FDA approval of aducanumab, the FDA has also provided “Breakthrough therapy designation” for Lilly’s Donanemab and Eisai’s Lecnemab which also are monoclonal antibodies that remove brain amyloid plaques and may slow cognitive decline. Aducanumab approval will impact clinical practice. The effects on AD clinical research will be profound in both positive and negative ways. This Editorial reflects the opinion of the leadership of the Alzheimer’s Disease Neuroimaging Initiative (ADNI), a large multisite longitudinal observational study with the goal of validating biomarkers for clinical trials. ADNI data have been used to help design and statistically power many AD clinical trials, including the aducanumab studies.