30 November 2022

Side effect?

Antibody against Alzheimer's disease may have caused the death of two patients

Irina Konova, PCR.news

On Tuesday, November 29, Eisai and Biogen presented the full results of phase 3 of lecanemab, a humanized monoclonal antibody of the IgG1 class that binds to the soluble form of beta-amyloid — protofibrils. On the same day they were published in NEJM (van Dyck et al., Lecanemab in Early Alzheimer's Disease).

Lekanemab is considered a promising drug against Alzheimer's disease. In CI, it was tested on patients with an early stage of this ailment. Of the 1,795 participants, 898 received the drug, 897 received a placebo. Infusions were carried out once every two weeks. After 18 months, changes in cognitive abilities, amyloid deposits in the brain and markers of tau pathology in the brain and cerebrospinal fluid were evaluated. Lekanemab reduced the values of markers of amyloid pathology. In addition, cognitive abilities decreased more slowly in the participants of the drug group than in patients from the placebo group. At the same time, taking lekanebam was associated with side effects, the frequency of which exceeded that for placebo. The most common adverse events associated with the method of administration of the drug, as well as micro- and macrohemorrhagia of the brain, edema or effusion, etc. 0.7% and 0.8% of participants in the lecanemab and placebo groups died during CI, respectively, while, according to the researchers, none of the deaths were associated with lecanemab.

However, a day earlier, on November 28, Science and other resources reported a second death, presumably related to lekanemab. A woman aged 65 years took the drug as part of the CI. She was hospitalized with a stroke, she was prescribed standard therapy — a plasminogen activator, but after starting treatment, bleeding in the brain opened, and a few days later the woman died. The first death became known a month ago. A man aged about 90 years who received lecanemab died from bleeding in the brain after taking an anticoagulant.

Despite the fact that the development companies denied the connection of this death with the drug, some experts believe that lekanemab may be dangerous for certain groups of patients. In particular, according to Science, in the second case, an autopsy revealed cerebral amyloid angiopathy (CAA) — a condition in which amyloid is deposited in the walls of the brain vessels. It is possible that when the amyloid is removed with lecanemab, the vessels become more fragile, which leads to bleeding while taking anticoagulants. Interestingly, earlier experts strongly discouraged the use of another drug against Alzheimer's disease, aducanumab, with a similar mechanism of action, in CAA.

The preliminary results of the lekanemab test were published by AISAI and Biogen in September 2022. The application to the FDA for accelerated approval of the drug was filed in the summer. Now Eisai will discuss the final results of the CI with regulators in the USA, Japan and Europe. The FDA must make a decision on the drug by January 6, 2023. CAA is often found in patients with Alzheimer's disease. Some experts believe that regulators should take this pathology into account when developing conditions for the use of lekanemab and warn about the danger of taking the plasminogen activator together with lekanemab.

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