Rates of amyloid-related imaging abnormalities (ARIA) in Alzheimer’s disease patients treated with lecanemab in the real world were consistent with those seen in clinical trials, data from the LEADER study showed.
Importance of Monitoring
Anti-amyloid drugs like lecanemab require MRI monitoring for ARIA, making prescriber-radiologist collaboration essential, said Daryl Rhys Jones, PhD, of Eisai in Nutley, New Jersey, at the American Society of Functional Neuroradiology meeting in Newport Beach, California.
ARIA is a consequence of amyloid in blood vessel walls. Two types of ARIA can emerge after anti-amyloid drug treatment: ARIA with edema or effusion (ARIA-E) or ARIA with hemosiderin or hemorrhage (ARIA-H).
Real-World Findings
In the real-world LEADER study, ARIA rates appeared to be lower than rates seen in the phase III CLARITY AD trial of lecanemab, though the differences may not be significant:
- Any ARIA: 12.3% vs 21.3%
- ARIA-E: 6.5% vs 12.6%
- ARIA-H: 7.6% vs 17.3%
- Concurrent ARIA-E and ARIA-H: 1.9% vs 8.2%
The median time to ARIA-E was 3.4 months, Jones reported. Results were similar between 1.5T and 3T MRI. This suggests that the power of MRI is not really making a difference in detection, at least in the real world.
ARIA rates in LEADER were consistent with other real-world evidence, including data from the ALZ-NET registry.
Understanding Lecanemab
Lecanemab, an antibody directed against aggregated forms of amyloid beta, was approved in 2023 to treat mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia. The drug carries a boxed warning that ARIA-E or ARIA-H can occur, with heightened incidence in APOE4 homozygotes compared to heterozygotes and noncarriers.
ARIA is often asymptomatic, and occasionally it can be severe. Lecanemab prescribing information requires MRI at baseline and after 1, 2, 3, and 6 months of treatment to monitor for ARIA.
LEADER Study Overview
LEADER is an ongoing, multisite, retrospective study that evaluates lecanemab in clinical settings. It incorporates surveys and interviews with healthcare practitioners along with chart and electronic medical record data for up to 50 patients per site.
This interim analysis was based on data from 432 patients with early Alzheimer’s disease. All participants received at least seven biweekly lecanemab infusions. Some received intravenous (IV) or subcutaneous maintenance treatment after 18 months of IV initiation treatment. Participants had an average of 520.7 days on lecanemab and an average of 25.8 doses.
The LEADER study includes diverse real-world settings. There are general neurologists treating patients for the first time who successfully implemented lecanemab and monitored its safety.
Collaboration and Expansion
Close prescriber-radiologist collaboration was crucial. Clear communication was needed to ensure that the radiologist understood the requirements, such as whether there is no ARIA or if there is ARIA but it is asymptomatic and mild.
The analysis included 12 LEADER sites, but now there are 20 sites, and patient numbers are expanding. The study is also looking at subcutaneous administration, which the FDA approved earlier this year.
Disclaimer: The information provided herein is for educational purposes only and should not be considered as medical advice. Always consult a healthcare professional for any medical concerns.
Fuente: https://www.medpagetoday.com/meetingcoverage/asfnr/123426
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