Dr. Thambisetty said the 2 deaths add to questions on lecanemab’s questions of safety “in real world clinical practice where patients are more likely to be sicker and have multiple other medical conditions in contrast to rigorously chosen patients in clinical trials.”
Nonetheless, the information on lecanemab, which Dr. Gandy noted attacks a special type of amyloid than previously tested drugs do, showed significantly lower rates of swelling and bleeding than with Aduhelm.
Nearly 13 percent of patients receiving lecanemab experienced brain swelling, which was mild or moderate usually, while lower than 2 percent of patients receiving the placebo experienced such swelling, the study reported. Most brain swelling didn’t cause any symptoms and customarily resolved inside a number of months. About 17 percent of lecanemab patients experienced brain bleeding, compared with 9 percent of patients receiving the placebo. Essentially the most common symptom from brain bleeds was dizziness, the study said.
The authors reported that “serious hostile events” occurred in 14 percent of lecanemab patients and 11 percent of those receiving placebo. Nearly 7 percent of lecanemab patients dropped out of the trial due to negative negative effects, greater than twice the proportion of placebo recipients who dropped out. Greater than 1 / 4 of the lecanemab patients experienced hostile infusion-related reactions, which included fever and flu-like symptoms, normally with the primary dose. A much smaller percentage of placebo patients experienced those reactions, the study found.
The principal positive end result of the study was that lecanemab patients declined cognitively by 1.21 points, while patients receiving placebo declined by 1.66 points on the 18-point scale, which assesses functions like memory, problem-solving and each day activities via interviews with patients and caregivers.
This result was supported by secondary measures within the trial, including three other cognitive tests, bolstering the chance that the drug is having an actual effect, experts said. As well as, on all of the measures, patients began showing slower decline several months after starting lecanemab, and the pace slowed further in the course of the 18-month trial.
The trial made an effort to incorporate more participants of color than have typically been enrolled in Alzheimer’s trials. About 25 percent of those that participated within the trial in the USA were Black or Hispanic, the study reported. It also allowed individuals with various medical conditions to participate, including hypertension, diabetes, heart disease, obesity and kidney disease.