The Alzheimer’s Disease and Related Disorders Therapeutics Work Group (ADRD TWG) has released Appropriate Use Recommendations (AURs) for Leqembi (lecanemab; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) as treatment for early Alzheimer disease (AD).

Leqembi, an anti-amyloid monoclonal antibody, was approved by the Food and Drug Administration (FDA) on an accelerated pathway following phase 2 and 3 trials (NCT01767311; NCT03887455) that showed it reduced amyloid plaques. The ADRD TWG treatment recommendations are based on data from those trials as well as FDA Prescribing Information (PI) and research and care information regarding AD.

The AURs cover patient selection, adverse events, and discussions with potential patients.

  • Patients should be selected based on the inclusion and exclusion criteria established for the phase 2 and 3 clinical trials associated with the approval of Leqembi.
  • Amyloid related imaging abnormalities (ARIA) are a significant, though typically asymptomatic, potential side effect associated with Leqembi treatment.
  • Clear communication between clinicians and patients/caregivers is vital as patients must understand the potential benefits/harms and monitoring requirements associated with Leqembi therapy.

Source: Cummings J, Apostolova L, Rabinovici GD, et al. Lecanemab: appropriate use recommendations. J Prev Alzheimers Dis 2023;10:362–377. doi.org/10.14283/jpad.2023.30