Guidance on Safe Use of Donanemab for Alzheimer Disease in Clinical Settings: Gil Rabinovici, MD

WATCH TIME: 7 minutes

"The Appropriate Use Recommendations for donanemab are designed with a conservative approach that emphasizes patient safety, addressing the real-world risks of amyloid-related imaging abnormalities and other potential adverse effects."

Earlier this summer, the FDA approved donanemab (Kisulna; Eli Lilly), a monoclonal IgG1 antiamyloid antibody, for treating patients in the early clinical stages of Alzheimer disease (AD). The approval was based on phase 2 (TRAILBLAZER-ALZ) and phase 3 (TRAILBLAZER-ALZ-2) trials, which incorporated innovative methodologies that may be challenging to apply in routine clinical settings.¹ Post approval, clinicians have emphasized the necessity of individualized clinical judgment and collaborative decision-making when considering donanemab therapy for each patient with Alzheimer.

Thus, the Appropriate Use Recommendations (AUR) were developed to support clinicians in integrating donanemab into real-world practice, with a strong focus on safety and maximizing therapeutic benefit. Established by the Alzheimer’s Disease and Related Disorders Therapeutic Workgroup and expert advisors, the guidelines are based on a thorough review of clinical trial findings, FDA prescribing information, and additional literature. Experts anticipate that these recommendations will adapt over time, aligning with advances in AD biomarker research and therapeutic experience.²

These insights were presented by lead author Gil Rabinovici, MD, professor of neurology and radiology at University of California, San Francisco, as part of a late-breaking communications session at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29 to November 1, in Madrid, Spain. At the meeting, Rabinovici sat down with NeurologyLive^® to talk about the key patient eligibility criteria for donanemab treatment, and why they are critical. He also spoke about how the clinical trial requirements impacted the feasibility of donanemab’s use in everyday practice. Furthermore, Rabinovici discussed the safety considerations and monitoring strategies for preventing or managing amyloid-related imaging abnormalities in patients on donanemab.

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REFERENCES
1. Lilly's Kisunla™ (donanemab-azbt) Approved by the FDA for the Treatment of Early Symptomatic Alzheimer's Disease. News Release. Eli Lilly. Published July 2, 2024. Accessed November 11, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early
2. Rabinovici G, Salloway S, Schindler S, et al. Donanemab: appropriate use recommendation. Presented at: 2024 CTAD; October 29-November 1; Madrid, Spain. LB01.