Even though amyloid-reducing monoclonal antibodies (MABs) are on the market and some research shows they may treat Alzheimer’s disease and dementia, a new research review found there aren’t clear benefits and there are definite harms associated with taking them, according to a meta-analysis in Annals of Family Medicine out Monday.
Previous research has come under fire for adequately assessing the efficacy and harms of using MABs for amyloid reduction. The authors said they haven’t included recent research, and some of the evidence used was from earlier phases of trials that included different doses. Overall, they don’t believe other researchers properly interpreted the findings.
Recently, MABs such as lecanemab and aducanumab were studied as part of large randomized controlled trials that saw substantial reductions in amyloid deposition but only modest improvements in cognition and function.The researchers saw significant harms to people taking the medications such as hemorrhage and symptomatic amyloid-related imaging abnormalities of edema.
In general, MABs tend to be expensive, costing about $26,500 to $28,200 per year. People who take them must undergo regular monitoring with an MRI, which can also be costly. MABs aim to reduce the accumulation of amyloid protein, which is linked to the development of cognitive diseases. Past studies have been based on improvements in lab measures such as biomarkers and imaging, but they haven’t examined whether or not the medications can reduce death, the authors pointed out.
Research led by Mark H. Ebell, MD, from the College of Public Health at the University of Georgia performed a meta-analysis of 19 randomized trial studies that looked at using MABs in people with cognitive impairment, dementia or Alzheimer’s disease. The research compared using the MABs compared to placebos. The MAB doses used were consistent with that used in phase 3 or Food and Drug Administration trials. The studies included had to report at least one clinically relevant benefit or harm after at least one year from when the person started taking the MAB. The studies used included data on 23,202 participants.
There wasn’t a single study included that showed that MABS improved cognitive abilities or day-to-day functional abilities surpassing minimal clinically important differences (MCIDs). The trials showed MABs were tied to statistically significant harms and could increase patients’ risk of serious issues like hemorrhage, cerebral edema, serious adverse events, and death.
“Our meta-analysis shows that monoclonal antibodies targeting amyloid do not provide a clinically meaningful benefit, are associated with significant harms, and come at a high cost,” the authors wrote.
