2023-12-20 08:00:37
Since January 2023, two humanized antibodies have been available on the American market to slow the progression of Alzheimer’s disease. How effective are these new treatments? Could they soon be available in Europe and France? Determining questions for the nearly one million people affected in France.
Immunotherapy once morest Alzheimer’s disease
On January 6, 2023, the American drug agency gave the green light to the marketing of lecanemab, indicated in the early phases of development of the Alzheimer’s disease. This humanized antibody, directed once morest the amyloid protein, is the second immunotherapy drug to be available on the American market following aducanumab (authorized since 2021). Lecanemab targets the precursor elements of amyloid plaques, found in the brains of patients with the disease. With the accumulation of the Tau protein in neurons, amyloid plaques are considered by researchers to be one of the two essential mechanisms of Alzheimer’s disease.
At this stage, lecanemab acts on the progression of the disease, to limit neurodegeneration. It must be administered as soon as possible following diagnosis and therefore in patients affected by early stages. The goal is to slow the progression of the disease and delay dependence. But the antibody is not intended to cure Alzheimer’s disease. It is indicated in the USA for patients with mild cognitive impairment and whose amyloid burden (presence of cerebral amyloid plaques) has been assessed by imaging or lumbar puncture.
Slow down the progression of the disease by limiting the development of amyloid plaques
In clinical trials conducted on the lecanemab antibody, efficacy was assessed by calculating a specific score, the CDR-SB (Clinical Dementia Rating-Sum of Boxes), taking into account the functional and cognitive abilities of patients. This score ranges from 0 (no disease) to 18 (end-stage disease). At the start of the study, patients had an average score of 3.2. After 18 months, patients on placebo had a score increased on average by 1.66, compared to only 0.45 in patients on lecanemab. The progression of the disease was therefore not stopped, but slowed by 27% compared to no treatment.
Like any medication, lecanemab has side effects. The main adverse effects found in clinical trials were bleeding and brain swelling. The risk of bleeding would be increased in patients carrying certain genetic variations associated with Alzheimer’s disease. For this reason, lecanemab is contraindicated in patients taking anticoagulants. Such side effects require regular medical monitoring of treated patients.
A decision expected in Europe for 2024
In practice, lecanemab is administered in a specialized department, by intravenous infusion every 15 days. The arrival of these two immunotherapy drugs in Alzheimer’s disease marks a major turning point in the management of this dementia, which is most common among the elderly. Lecanemab would allow gain 19 months of autonomy out of the 6 years hoped for at the time of diagnosis. Even if this result seems promising, it nevertheless remains to be put into perspective. For experts, it is difficult to envisage a real clinical improvement in each patient treated with the antibody. But these data demonstrate that the immunotherapy route can open up interesting perspectives in Alzheimer’s disease.
An application for Marketing Authorization (MA) has been submitted to the European public health authorities. The European Medicines Agency (EMA) might make its decision in early 2024.
Estelle B., Doctor of Pharmacy
Sources
– Authorization of lecanemab by the FDA, a new era in the fight once morest neurodegenerative diseases? www.sante-sur-le-net.com. Accessed December 11, 2023.
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