Donanemab Appropriate Use Recommendations Presented at CTAD 2024

Guidelines for the use of Kisnula (donanemab; Eli Lilly and Company, Indianapolis, IN) for the treatment of Alzheimer disease (AD) in clinical practice were presented at the 17th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference. These Appropriate Use Recommendations (AUR) provide a framework for patient selection and the implementation of Kisnula treatment in real-world practice and were developed by consensus by the AD and Related Disorders Therapeutic Workgroup along with invited experts.

The Workgroup developed the AUR based on a review of clinical trial data, Food and Drug Administration (FDA) prescribing information, and other relevant literature.

The AUR includes guidance on the following topics:

• Considerations for disease, clinical, and biomarker characteristics when selecting candidates for treatment with Kisunla
• The necessity of apolipoprotein E (APOE) genotyping for predicting risk of amyloid-related imaging abnormalities
• The use of pretreatment MRI to exclude patients with white matter disease or evidence of cerebral amyloid angiopathy
• Advisement against treatment with Kisunla for patients taking anticoagulants
• The contraindication of thrombolytics for patients on active therapy with Kisunla
• The discontinuation of treatment for patients with a negative follow-up amyloid PET

The authors note that, when determining whether treatment with Kisunla is appropriate for a given patient, it is important to incorporate individualized clinical judgement and shared decision-making, and that the guidelines may evolve as more real-world data and clinical experience are reported.