by Cristina Brown
The monoclonal antibody donanemab shows a 35% slowdown in disease progression, but risks-benefits must be evaluated due to the important and serious side effects
A new drug, donanemab, a monoclonal antibody, appears to slow cognitive decline due to Alzheimer’s disease. This is demonstrated by the study of the University of California, San Francisco, published on JAMA,
anticipated in May with a press release from the pharmaceutical company Eli Lilly. This is the third drug that targets the pathological mechanism of accumulation of amyloid beta in the brain, typical of Alzheimer’s disease. The US FDA has already approved two other drugs: aducanumab and lecanemab.
The study of 1,736 patients reported that the drug donanemab can modestly slow the progression of memory and thinking problems in the early stages of Alzheimer’s. Cognitive slowdown increased for early-stage patients when limited amyloid beta accumulation.
After about a year and a half, the drug appears to have slowed cognitive decline by 35% with detectable clinical results in patients treated at an early stage and by 22.3% if all patients were considered. These data translate into a 4- to 7-month slowdown in cognitive decline. In addition, about half of the patients treated with the new drug had no clinical worsening for at least a year, compared with 29% of the patients who received the placebo.
The results of the trial come a few days after the full approval by the FDA of lecanemab, a drug with a mechanism of action similar to donanemab.
However, some issues remain to be resolved, for example the extent of the clinical benefits in relation to the risks of these treatments. In fact, many scientists speak of statistically significant results in favor of the drug but of little relevance from a clinical point of view and may not mean much to patients on a practical level, bearing in mind that the risks are very evident.
Donanemab, like other monoclonal antibodies, can in fact cause important side effects. Some patients have developed a condition called Aria (amyloid-related imaging abnormalities), which is swelling or micro-bleeding in certain areas of the brain. 24% of donanemab-treated participants developed cerebral swelling, 31.4% suffered microhemorrhages. In most cases the symptoms were rated as mild or moderate, while 1.6% developed severe symptoms. Three patients died during the trial from causes possibly attributable to this side effect.
These drugs herald a new era of Alzheimer’s disease therapy, reads an editorial in the same issue of the journal JAMA. Accurate and timely diagnosis, thoughtful discussion of individualized risks and benefits, and an emphasis on chronic care management have never been more important, the comment authors write.
July 17, 2023 (change July 17, 2023 | 5:46 pm)
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