See important safety information, including boxed warning, in the attached prescribing information.

Amyloid-related imaging abnormalities (ARIA) were identified via magnetic resonance imaging (MRI) in the TRAILBLAZER-ALZ 2 clinical trial.1

The protocol requirements for reporting MRI findings consistent with ARIA differed for amyloid-related imaging abnormalities-edema (ARIA-E) vs amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H).1

For MRI findings consistent with ARIA-E, investigators completed an ARIA-E Related Events case report form and reported the event as an treatment-emergent adverse event (TEAE) in the Adverse Event case report form.1

The TRAILBLAZER-ALZ 2 protocol did not dictate the completion of a case report form to

• capture symptoms associated with ARIA-H identified on MRI, nor
• report it as a TEAE.1

Ultimately, diagnosis of ARIA requires identification via brain MRI imaging. Even if an ARIA-H event was not reported as a TEAE, it would be separately captured via centralized MRI reading as part of the study protocol.1

Figures for ARIA-H noted as TEAE do not encompass all ARIA-H occurrences due to the reporting framework mentioned. The rates that more accurately represent ARIA-H occurrence in a study are assessed by

• MRI or
• MRI and TEAE cluster.

KISUNLA™ (donanemab-azbt) injection, for intravenous use, Lilly

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).