Rare side effects detected in real-world usage of lecanemab for Alzheimer's treatment
Unleashing the Real World: Lecanemab and Alzheimer's - A New Chapter in Dementia Treatment
In the far-reaching quest for a cure, dementia's vicious adversary Alzheimer's disease has seen a new contender step into the battlefield - lecanemab, a groundbreaking medication granted the green light by the U.S. FDA in 2023.
While lecanemab potentially offers a beacon of hope for those afflicted, like all warriors, it carries a burden - the risk of side effects. Among these, amyloid-related imaging abnormalities (ARIA) loom large, including brain swelling or bleeding.
November 2022 saw the publication of the Clarity AD phase 3 clinical trial, which sought to evaluate lecanemab's safety and effectiveness in individuals with early Alzheimer's disease. The study revealed mere traces of ARIA among participants, strengthening the intrigue surrounding lecanemab.
Now, a newly unveiled study underscores the Clarity AD findings, asserting that significant adverse events, like ARIA, are largely uncommon and manageable, particularly for those within the earliest stages of Alzheimer's disease.
Diving into the Depths of Lecanemab
For this exploration, researchers enlisted 234 individuals with early-stage Alzheimer's disease, averaging approximately 74 years old, who received lecanemab at the outpatient specialty memory clinic, Washington University Memory Diagnostic Center.
Barbara Joy Snider, MD, PhD, a professor of neurology at WashU Medicine and affiliated with the Knight Alzheimer's Disease Research Center, offered insights, "Lecanemab is an antibody, a type of protein typically produced by your body's immune system. Antibodies like lecanemab are fabricated, then administered to patients. Antibodies are employed in a variety of conditions."
Lecanemab and Amyloid Proteins - A Symbiotic Struggle
Lecanemab was developed to recognize specific amyloid proteins, misfolded proteins that can disrupt brain activity and form clumps called plaques. This is a common occurrence in Alzheimer's disease. While misfolding isn't the sole cause of Alzheimer's disease, it may be one of the first steps leading to memory loss and dementia.
"In a substantial clinical trial, individuals treated with lecanemab for 18 months experienced about 25-30% less cognitive decline compared to those not receiving the medication," Snider revealed. "It's important to acknowledge that treated individuals still experienced cognitive decline; lecanemab didn't reverse or completely halt memory loss, but it significantly slowed it down. Imaging studies demonstrated that lecanemab also reduced and sometimes eliminated the amyloid plaques in the brain."
A Peek into ARIA's Real-World Dominion
At the study's culmination, researchers uncovered that 1.8% of participants at the earliest stage of Alzheimer's disease showed signs of ARIA, contrasted with 27% of participants with mild Alzheimer's disease.
"This finding underscores the importance of early diagnosis," Snider emphasized. "The clinical trial results showed that people with very mild symptoms likely benefit more from medications like lecanemab (40-50% slowing of decline instead of 25-30%), so people with very mild symptoms have more benefit and fewer side effects. This is also when it's hardest to be sure someone has Alzheimer's disease, so it's crucial that we continue to work to improve access to diagnosis for people with very mild symptoms."
Snider and her team discovered that of the 11 participants who experienced ARIA symptoms, the effects largely dissipated within a few months, and no patients met their end. "This is quite similar to what was observed in the clinical trial," Snider noted. "This is extremely reassuring and signals that these drugs can be utilized safely in a real-world clinic population."
Lighting the Path for Further ARIA Research
As lecanemab makes its entrance into treatment options for early-stage Alzheimer's disease, the quest for understanding increased ARIA risk continues. Researchers hope to identify these risk factors to offer patients personalized, informed decisions about their treatment options. This includes whether or not to venture down the anti-amyloid therapy path and, if so, whether lecanemab or donanemab would be the better choice.
- Lecanemab, an antibody used in various medical conditions, targets specific amyloid proteins in Alzheimer's disease, misfolded proteins that can disrupt brain activity and form clumps called plaques.
- In a substantial clinical trial, individuals treated with lecanemab for 18 months experienced approximately 25-30% less cognitive decline compared to those not receiving the medication, and imaging studies demonstrated that lecanemab reduced and sometimes eliminated the amyloid plaques in the brain.
- A study at the Washington University Memory Diagnostic Center revealed that 1.8% of participants at the earliest stage of Alzheimer's disease showed signs of ARIA, contrasted with 27% of participants with mild Alzheimer's disease.
- Researchers hope to identify risk factors for increased ARIA risk to offer patients personalized, informed decisions about their treatment options, including whether or not to venture down the anti-amyloid therapy path and, if so, whether lecanemab or donanemab would be the better choice.
- The study findings indicate that these drugs can be utilized safely in a real-world clinic population, with ARIA effects largely dissipating within a few months and no patients meeting their end.
