Aducanumab: Appropriate Use Recommendations
Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. As clinicians require guidance on the appropriate use of this new therapy, an Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus.
The Expert Panel recommended that use of aducanumab be restricted to this population in which efficacy and safety have been studied. As aducanumab is titrated to a dose of 10 mg/kg over a 6-month period, the Expert Panel recommended that the aducanumab be titrated to the highest dose to maximize the opportunity for efficacy. Given that aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage, dose interruption or treatment discontinuation is recommended for symptomatic ARIA and for moderate-severe ARIA. The Expert Panel recommended the use of MRIs prior to initiating therapy, during the titration of the drug, and at any time the patient has symptoms suggestive of ARIA. The Expert Panel also recommended that measures less cumbersome than those used in trials be used for the assessment of effectiveness in the practice setting.
The Expert Panel emphasized the critical importance of engaging in a process of patient-centered informed decision-making that includes comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits.
Source: Cummings J, Aisen P, Apostolova LG, Atri A, Salloway S, Weiner M. Aducanumab: Appropriate Use Recommendations. J Prev Alzheimers Dis. 2021;8(4):398-410. doi: 10.14283/jpad.2021.41.