Simulation Model Suggests Lecanemab Slows Rate of Disease Progression in Early Alzheimer
A best-case analysis indicated that, for amyloid-positive patients diagnosed with MCI due to AD or mild AD dementia, lecanemab plus standard of care provided an additional gain of 0.75 in quality-adjusted life years.
Using the AD Archimedes condition-event (ACE) disease stimulation model, investigational agent lecanemab (BAN2401; Eisai) was estimated to slow the rate of disease progression, resulting in an extended duration of mild cognitive impairment (MCI) due to Alzheimer disease (AD) and mild AD dementia and shortened duration in moderate and severe AD dementia. After gaining fast track designation in June 2021, Eisai still anticipates completing lecanemab’s rolling submission of a biologics license application in the first quarter of the company’s fiscal year, which began April 1, 2022.1,2
Compared with standard of care (SoC) alone, the proportion of patients on lecanemab plus SoC who progressed to mild AD, moderate AD, and severe AD were reduced by 7%, 13%, and 10%, respectively. The model also predicted a 25% lifetime probability of needing institutional care for those who received the combination of treatments vs 31% for those on SoC alone.
"The findings from the simulation model suggest early treatment with lecanemab may delay progression to the more severe stages of AD, potentially giving people living with early AD and their loved ones more time together and possibly reducing healthcare costs,” Ivan Cheung, chairman and senior vice president, and president, Neurology Business Group and Global Alzheimer’s Disease Officer, Eisai, said in a statement.1 “These predicted and simulated long-term health outcomes provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab."
The analysis was of Study 201 (NCT01767311), a phase 2b proof-of-concept trial that originally showed a reduction in brain amyloid in lecanemab-treated patients. Those findings, as well as consistent reductions observed across several clinical and biomarker end points, were the basis for the