A panel of experts in the Alzheimer’s field this morning published the first recommendations for the appropriate use of aducanumab (Aduhelm), the controversial new drug to treat early, mild disease.
“Aducanumab: Appropriate Use Recommendations” was published online by The Journal of Prevention of Alzheimer’s Disease simultaneously with a session at the Alzheimer’s Association International Conference 2021.
Aducanumab was the first new therapy for Alzheimer’s disease to be approved in almost two decades by the Food and Drug Administration when it was approved June 7 in the United States. Subsequently, however, three FDA advisory panel members resigned and House committees said they would investigate the approval.
The advice released Tuesday — developed in response to requests for additional information from clinicians — was created by a panel of experts with experience in Alzheimer’s research, clinical trials and drug development. It is based on information from clinical trials of aducanumab, updated FDA prescribing information and expert consensus.
“The goal of the [recommendations] is to provide guidance for the safe and effective use of this new drug, in particular because aducanumab is an unprecedented therapy,” Jeffrey Cummings, M.D., one of the authors, said in a news release. “The recommendations fill the gap between the prescribing information and the real-world implementation of this treatment.”
The four key recommendations from the panel cover identifying the appropriate patients and dosage of the drug, monitoring for side effects, and communicating with individuals and care partners about potential side effects and risks, as well as expectations. Specifically, the panel said that:
- Use of aducanumab should be restricted to the population in which efficacy and safety have been studied.
- Aducanumab should be titrated to the highest dose to maximize the opportunity for efficacy.
- Magnetic resonance imaging should be performed before therapy begins, during the titration of the drug, and at any time the individual has symptoms that suggest amyloid-related imaging abnormalities.
- It is critical to engage in person-centered informed decision-making that includes comprehensive discussions and clear communication with the individual 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.
Additional recommendations address when to stop therapy and which patients should not receive the drug.
According to the authors, opportunities and challenges exist for the introduction of the drug into the management of Alzheimer’s disease patients.
“Building [the] infrastructure for the appropriate use of aducanumab will require time, resources and creating planning,” they wrote. “Appropriate use of aducanumab requires a commitment to patient-centered care and best practices for the safe delivery of this new treatment.”
Alzheimer’s Association Chief Science Officer Maria C. Carrillo, Ph.D., said a June 21 dialogue session highlighted the “urgent need for a consensus protocol” for clinicians.
“This is an important starting point, and this JPAD article, and the constructive response to it from the field, will be the basis for additional tools to educate and support clinicians, both primary care physicians and dementia specialists,” Carrillo said in a news release.
The key recommendations also were published in Alzheimer’s & Dementia: Translational Research and Clinical Interventions.