New Clinical Guidance for Treating Alzheimer Disease with Antiamyloid Monoclonal Antibodies Published

The journal Neurology has published a new “Emerging Issues in Neurology” article that provides guidance for clinicians about decision-making regarding antiamyloid monoclonal antibodies (mAbs), which are an emerging therapeutic option in the treatment of Alzheimer disease (AD). One antiamyloid mAb, Leqembi (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA), received full Food and Drug Administration (FDA) approval for the treatment of people with Alzheimer disease (AD) in July, and has been shown to slow the rate of functional and cognitive decline in patients.

The following key points summarize the guidance provided in the article:

• Due to the indications and side effects of Leqembi and other antiamyloid mAbs, such as amyloid-related imaging abnormalities (ARIA), clinicians will need to evaluate a number of factors in their patients before initiating treatment, including stage of disease, level of cognitive impairment, presence abnormal brain amyloidosis, comorbid conditions, potential drug interactions, and apolipoprotein E ε4 (APOE ε4) allele status.
• Shared, deliberative decision-making that involves clinicians, patients, caregivers, and family members will be essential, especially due to the complicated nature of both AD and this treatment option.
• While Leqembi is indicated for administration by intravenous (IV) infusion every 2 weeks, further office visits will be necessary for MRI monitoring of ARIA, with an additional need for emergency pathways, as well as effective communication with radiology teams.
• New communication systems and digital infrastructure may be necessary so that clinicians can triage, diagnose, and evaluate benefit of antiamyloid mAb treatment in their patients; there may also be a need for new drug reimbursement programs.
• Regulatory action from the FDA for donanemab (Eli Lilly and Company, Indianapolis, IN), another antiamyloid mAb, is expected by the end of 2023, and if approved, clinicians will need to weigh the benefits of Leqembi, donanemab, and other potential emerging antiamyloid mAbs, with specific workflows for each.

The article’s authors also note that research into antiamyloid mAbs is ongoing, and aspects of patient selection, side effects, and treatment timing may change in the future, requiring further clinician adaptability. AD is a progressive, debilitating, and devastating disease with few treatment options, meaning that new therapeutic agents, such as antiamyloid mAbs, may become an essential tool for clinicians.