Key takeaways:
- Lecanemab led to extra infusion reactions than in CLARITY-AD scientific trial.
- Sufferers had decrease ARIA charges in ApoE4 noncarriers vs. CLARITY-AD
- Extra security knowledge can be collected amongst this affected person inhabitants.
Lecanemab could also be protected and efficient for treating early-stage Alzheimer’s illness inside a small neighborhood of older adults, with decrease charges of amyloid-related imaging abnormalities in contrast with the CLARITY-AD scientific trial.
“One of many main questions concerning the FDA approval of lecanemab was whether or not the remedy may very well be safely administered into scientific apply,” Armen J. Moughamian, MD, PhD, cognitive neurologist and medical director on the Ray Dolby Mind Well being Heart, Sutter Well being in San Francisco, informed Healio concerning the analysis introduced on the Alzheimer’s Affiliation Worldwide Convention. “A lot of the information introduced up to now [are] from scientific trials or specialised educational facilities.”
Knowledge have been derived from Moughamian AJ, et al. Affected person traits and security of lecanemab in a big community-based cohort at Sutter Well being. Introduced at: Alzheimer’s Affiliation Worldwide Convention; July 27-31, 2025; Toronto.
Though granted FDA approval 2 years in the past as the primary disease-modifying remedy for AD, lecanemab (Leqembi, Eisai) infusion is related to the intense aspect impact of amyloid-related imaging abnormalities (ARIAs), which is most definitely to happen throughout the first 6 months, in addition to lesser adversarial occasions related to therapy.
Moughamian and colleagues sought to make clear the affected person and clinician expertise with lecanemab and ARIA inside Sutter Well being, a community-based well being care system, that oversees greater than 3.5 million sufferers in northern California, in contrast with the CLARITY-AD scientific trial, an 18-month, section 3 examine, that examined lecanemab in early-stage AD sufferers.
Their examine included 210 people (imply age, 75 years; 52% girls) handled with lecanemab between July 2023 and June 2024 who have been screened at a reminiscence clinic and deemed eligible primarily based on FDA suggestions. Moughamaian stated the examine’s affected person inhabitants resembled the CLARITY-AD cohort.
Among the many enrollees, 70% had delicate cognitive impairment and 30% had delicate dementia. Additionally, 56% have been constructive for apolipoprotein e4 allele (ApoE4) heterozygotes and 6% for ApoE4 homozygotes.
Moughamian and colleagues reported that 36% of sufferers skilled infusion reactions (91% delicate; 8% reasonable; 1% extreme), with discontinuation famous in 14% of individuals.
They additional famous 33 instances of ARIA (15.7%), which Moughamian stated was decrease than the speed in CLARITY-AD. Of these, 29 had the subtype ARIA-H (13.8%) and 16 had the subtype ARIA-E (7.6%), with ARIA current in eight of 78 (10.2%) ApoE4 noncarriers, 19 of 118 (16.1%) ApoE4 heterozygotes and 5 of 13 (38.4%) ApoE4 homozygotes.
Moreover, eight instances of extreme radiographic ARIA occurred (4 ApoE4 homozygotes, three ApoE4 heterozygotes and one ApoE4 noncarrier), of which three such instances have been symptomatic.
Knowledge additional present a complete of 5 deaths, none of which have been attributed to lecanemab therapy.
Comparatively, in CLARITY-AD, infusion-related reactions occurred in 26% of the therapy group and seven% within the placebo group; ARIA-H occurred in 14% of the therapy group and eight% within the placebo group, with ARIA-E logged in 13% and a pair of%, respectively; ARIA charges amongst APOE e4 allele non-carriers have been 13% and a pair of% respectively. “We conclude that lecanemab could be safely administered in a big, community-based well being care system and that ARIA is a manageable aspect impact when acceptable sufferers are chosen for therapy,” Moughamian informed Healio.
At the moment, he continued, Sutter Well being has greater than 600 sufferers on lecanemab or donanemab (Kisunla, Eli Lilly) therapy with decrease charges of ARIA in contrast with scientific trials.
“Our future research will proceed to gather security knowledge on all sufferers handled within the Sutter Well being system,” he stated.
Reference:
Be taught extra concerning the Section 3 CLARITY-AD trial. https://www.leqembihcp.com/about-leqembi/study-2-clarity-ad. Accessed July 25, 2025.
For extra info:
Armen J. Moughamian, MD, PhD, could be reached at psychiatry@healio.com.
