A new study just out in JAMA Neurology demonstrates the impact, effectiveness and safety of Lecanemab in real-world settings. This particular antibody was controversially approved by the FDA in 2023 for the treatment of Alzheimer’s disease. Leqembi, the brand name for Lecanemab, works by targeting specific amyloid proteins that build up in the brain. This important treatment will help thousands of patients manage the symptoms and slow the progression of this debilitating condition.
Studies indicate that Lecanemab produces clinically important effects on patients with very mild to mild Alzheimer’s symptoms. It has the ability to slow cognitive decline by 40-50%, a slowdown much greater than the 25-30% decline seen in patients with later stage symptoms. The therapy acts to detect and remove amyloid plaques, which are thought to play a significant role in Alzheimer’s disease.
Lecanemab does come with risks. Common side effects associated with the drug include headaches, dizziness, muscle aches, and blurred vision. Amyloid-related imaging abnormalities (ARIA) represent the most serious risk. Such malformations can cause dangerous swelling or bleeding in the brain. In these clinical trials, ARIA-E (edema/effusion) occurred in less than 0.8% of participants and only 0.7% developed ARIA-H (hemorrhage/deposito Hemosiderin).
Dr. John Dickson of UT Southwestern was involved in the study. He added, “Overall, the risk of ARIA is greatest within the first six months of treatment.” He warned that in the trial, some patients were followed up for more than six months. Some participants were only monitored for 2 weeks or less, possibly resulting in an underestimation of ARIA events.
The study found that serious ARIA-related adverse events were uncommon among patients treated with Lecanemab. Even more importantly, whenever these events did happen, the impacts were survivable. Dr. Manisha Parulekar cautioned that ARIA is still a possibility for patients on lecanemab. Most importantly, she stressed, it’s been possible to contain the spread in our subspecialty treatment program. She noted that rigorous patient selection and ongoing monitoring will be crucial to ensuring treatment remains safe.
Those conclusions are consistent with previous clinical trial data. Among the participants who reported effects of ARIA symptoms, all but two of the cases continued to resolve within weeks to months with no sustained damaging effects, including fatalities reported. Dr. Barbara Joy Snider, global clinical lead for the NHP trial, added that this is very similar to what we saw in the clinical trial. She emphasized that real-world use of Lecanemab can make a dramatic difference.
Patients identified with very mild symptoms stand to benefit most from infusion therapies such as Lecanemab, says Dr. Snider. Output of the humanized picture “This result underlines the necessity of early diagnosis,” she said. Individuals with minimal, very mild symptoms may stand to gain the most from drugs such as lecanemab. So it is all the more important that we keep working on getting these simple, but invaluable, diagnoses out to those individuals.
Though the now-approved Lecanemab is a beacon of hope for millions of Alzheimer’s patients, the treatment brings with it multifaceted complications that healthcare professionals must consider. Dr. Parulekar said that it was easy to overlook the duality of the treatment. He added, “The approval of lecanemab is the first glimmer of hope for Alzheimer’s patients, but serious side effects raise the stakes of the decision faced by prescribing physicians.
We’ve heard from healthcare professionals loud and clear, they want better benefit-risk communication. Instead, they recommend taking a careful look at each patient’s individual profile. “Identifying patients who are most likely to benefit from lecanemab and least likely to experience serious side effects is crucial,” Dr. Parulekar noted.
Innovative new treatments for Alzheimer’s disease are coming online every day. At the same time, the medical community is taking strides to better understand how to diagnose and treat this intricate disease. And with more research, we need to have more standardized treatment protocols. This is necessary to make sure patients get the absolute best care that meets their individual needs.
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