Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published
A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
- A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
- This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
- The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
- The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.