An Alzheimer’s drug that had been hailed as a breakthrough may actually increase patients’ chances of dying, according to new research.
The treatment, lecanemab, was found to triple the risk of death within one year, compared to dementia patients who had not been prescribed the drug.
Previous studies have suggested that it slowed the progression of the incurable brain disease by 25 percent, giving patients approximately four to six more months of healthy life.
However, earlier this year, NHS spending watchdog NICE refused to fund the drug because it provides “relatively small benefits… meaning it cannot be considered good value”.
And last month, the watchdog also rejected donanemab, another drug that had shown promise in suppressing symptoms.
An Alzheimer’s drug that had been hailed as a breakthrough may actually increase patients’ chances of dying (file photo)
The treatment, lecanemab, was found to triple the risk of death in one year, compared to dementia patients who were not prescribed the drug (file photo)
Both lecanemab and donanemab are administered every fortnight as an infusion. They work by reducing a toxic protein in the brain called amyloid, which is linked to the symptoms of dementia.
Although it is not available on the NHS, the UK regulator has approved lecanemab for safe use, making it available to patients privately at a cost of around £20,000 a year.
However, the new research, which used data from the United States, where the drugs have been in use since last year, found that the risk of death was significantly higher than that reported in clinical trials.
This equates to 21 additional deaths per 10,000 patients taking lecanemab.
Experts say around 3,000 patients have started taking the drug since it was approved by US health officials in July 2023.
Patients taking these medications are at increased risk of life-threatening inflammation and bleeding in the brain.
The experts behind the study warn that “there is precedent for withdrawing drugs if their side effects or signs of mortality are concerning.”
Professor Robert Howard, one of the authors of the paper, said: “The idea that lecanemab is a miracle drug is not supported by evidence from trials.” It is even doubtful to say that they slow down progression, since this is just an interpretation. Following NICE’s decision, these are important findings.’
Experts say around 3,000 patients have started taking the drug since it was approved by US health officials in July 2023 (file photo)
Earlier this year, NHS spending watchdog NICE refused to fund the drug because it provides “relatively small benefits” (file photo)
Professor Howard, an expert in elderly psychiatry at University College London, added: “We must thank NICE for their leadership in this area, assessing the real costs – small benefits and huge risks with these drugs.”
“Anyone who has the money to buy lecanemab privately should consider it carefully, as the risks are real.”
The research has not currently been peer-reviewed and Professor Howard notes that “the data is currently preliminary and there is uncertainty over the actual figures.”
Real-world data on the drug’s use in the United States follows a series of deaths during trials.
About one in ten trial participants experienced swelling in the brain and one in six had small brain bleeds, which in rare cases caused life-threatening symptoms.
Three patients died in the trial. One death was confirmed by Dr. Lawrence Honig, a neurologist at Columbia University, New York. The scientific website Alzforum reported a second death.
None of the patients have been identified, but according to Dr. Honig, one of them carried a gene called APOE4, which puts patients at higher risk for brain hemorrhages.
About 15 percent of Alzheimer’s patients are carriers of this gene.
Previous studies have suggested it slowed the progression of this incurable brain disease by 25 percent (file photo)
Alzheimer’s disease is the most common cause of dementia. The disease can cause anxiety, confusion and short-term memory loss.
The Mail on Sunday was the first to report the third death, that of lecanemab trial participant Genevieve Lane, 79, from Florida, who suffered a fatal seizure in 2022, just a week after her third dose.
An autopsy concluded that lecanemab was likely to have caused a blood vessel to burst in his brain that led to his death.
A spokesperson for manufacturer Eisai said: “The manuscript published online includes a warning stating that ‘it should not be considered conclusive, used to inform clinical practice or referenced by the media as validated information.’
“It is also important to note that these data have not been peer-reviewed nor published in a journal.
“Data presented at recent medical meetings demonstrate that reports on lecanemab received to date have been consistent with the safety profile observed in
clinical development program and are continually reviewed by the FDA (US Food and Drug Administration) and Eisai’s pharmacovigilance team.’
