By Lucy Piper, medwireNews reporter
medwireNews: Real-world evidence from the USA for lecanemab use in patients with Alzheimer’s disease (AD) shows that patients are being appropriately selected, receiving treatment in line with dosing and monitoring guidelines, and are adherent.
The findings come from two studies presented at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Madrid, Spain, and showed similar experiences.
The first study used data from the Komodo Research Database on 3155 patients who started lecanemab treatment, predominantly since October 2023, and had a mean follow-up of 129 days since treatment initiation, as well as information on clinical activity 12 months prior.
The patients had a mean age of 75 years, and the majority were White (84.3%) and from urban areas (93.3%). There were slightly more women (55.8%) than men and “a lot of patients had comorbid conditions,” noted presenter Marwan Sabbagh from Barrow Neurological Institute in Phoenix, Arizona, USA.
The most frequent of these were dyslipidemia (54.4%) and hypertension (45.7%). Oral AD agents (acetylcholinesterase inhibitors or memantine) were being taken by 67.6% of patients, while 4.1% were taking antiplatelets and 3.7% anticoagulants.
In the 12 months before starting treatment, 83.8% of patients had a diagnosis of AD and 60.8% had mild cognitive impairment. The average time from first being diagnosed to receiving lecanemab treatment was 4.9 months, which Sabbah said as a practicing neurologist, he was “not surprised to see.”
He pointed out that the patients were otherwise receiving lecanemab “on label and on time,” averaging two monthly infusions with 16.5 days between each, and this was not delayed by the need for magnetic resonance imaging (MRI). The first MRI scan was conducted at a mean of 46.7 days post treatment initiation.
Sabbagh highlighted that patient adherence to lecanemab, defined as no interval of more than 90 days between two infusions, was “excellent,” at a rate of 85.1% at the mean 4-month follow-up, and patients were “highly motivated” to stay on lecanemab “once they understand the consequences of treatment and nontreatment.”
The second study was presented by Lawrence Honig who described his experience of clinical lecanemab use in 162 patients at the academic Irvine Medical Center in New York, USA, finding it to be “safe and manageable,” with “wide patient acceptance and compliance.”
The patients had an average age of 73.2 years, 56% were women, and 90% were White, and comorbid conditions were common, including cortical strokes and bleeds in 2% and vascular malformations in 3%. Apolipoprotein (apo)E genotyping was carried out in 89%, while the remaining 11% declined.
Eligibility for lecanemab treatment was based on evidence of MCI or AD confirmed by cerebrospinal fluid biomarkers in 86% of cases, positron emission tomography (PET) in 26%, and by both in 12%. Two per cent of patients had pacemakers and 1% were taking anticoagulants. The patients had an average Mini-Mental State Examination score of 23.6 points, but it ranged from 11.0 to 30.0 points.
Risk discussions were carried out with all patients and individuals were only excluded if they had more than four microhemorrhages on baseline MRI, “as long as we as practitioners felt comfortable offering it to our patients and, in turn, whether they felt comfortable accepting therapy,” said Honig.
Treatment was in accordance with FDA package insert information, with the patients receiving an average of 13.1 infusions over an 18-month period and up to four MRI scans. Nine unscheduled scans were carried out because of suspected amyloid-related imaging abnormalities (ARIA), one of which was found to be positive.
There was a 16% rate of infusion reactions, mainly chills, feeling hot, headaches, and fatigue, none of which resulted in hospitalization.
Treatment was paused in a total of 9% of patients, predominantly due to ARIA edema/effusion (ARIA-E), and 8% discontinued treatment, including one patient with ARIA-E, two with ARIA microhemorrhage (ARIA-H), and one apolipoprotein E4 homozygous patient with combined ARIA-E and ARIA-H who developed aphasia and received a same day MRI, but developed status epilepticus the next day and died 5 days later in intensive care from multi-organ failure.
Honig commented that “serious or lethal ARIA-E regretfully can occur even with best monitoring, early recognition, and best treatment, but it is uncommon.”
He added that “the ARIA-E and ARIA-H rates we experienced at our center are very similar to those experienced in the phase 2 and phase 3 studies of this drug,” with incidence cases of 11% and 5%, respectively. In the case of ARIA-E, it “typically occurred early like in the studies, was sometimes severe, but usually asymptomatic, and resolved within a few months, with dosing almost always resumed,” he said. Indeed, 16 of 17 cases of ARIA-E were asymptomatic.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group
CTAD24; Madrid, Spain: Oct 29–Nov 1
https://www.ctad-alzheimer.com
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