Physicians warn against off-label use of new Alzheimer’s disease drugs for cerebral amyloid angiopathy

According to Stephen Greenberg, MD, a new treatment recently approved by the U.S. Food and Drug Administration for patients with Alzheimer’s disease in considerable controversy is cerebral amyloid angiopathy (CAA), a similar cerebrovascular condition. Should not be prescribed by a doctor outside the label. .D. , Director of the Hemorrhagic Stroke Research Program at Massachusetts General Hospital (MGH) and Chairman of the International Association for Cerebral Amyloid Angiopathy (ICAAA).In the letter published in Lancet neurology, Greenberg and eight other officers of the association said that the monoclonal antibody aducanumab is beneficial to patients with CAA, a condition in which a protein known as amyloid can corrode the arterial walls of the brain, causing bleeding and stroke. He writes that there is no clinical evidence that it is.

“We believe there is considerable uncertainty and concern about both the safety and efficacy of aducanumab. patient Diagnosed with CAA [and] Therefore, believe [it] It should not be used to treat CAA outside the context of research trials. “

The FDA approved aducanumab on June 7 under the FDA’s accelerated approval process for drugs that treat serious conditions and meet unmet medical needs. Although the approval was specifically for Alzheimer’s disease, it opens the door for physicians to legally prescribe off-label use of aducanumab. Cerebral amyloid angiopathy..Indeed, CAA is thought to be caused by harmful accumulation, like Alzheimer’s disease. Amyloid Beta deposition in the brain. However, unlike Alzheimer’s disease, these deposits are usually Cerebrovascular, Not the brain tissue itself.By giving Green light Against aducanumab, the FDA has taken a stand against its own independent advisory board and many scientists and doctors who claim that there is no convincing evidence that the drug helps patients.

Leading authorities in the field of cerebral amyloid angiopathy are currently in their own position and recommend not to off-label aducanumab for the treatment of CAA. From an efficacy perspective, ICAAA officials said that cerebral vascular amyloid beta deposits appear to be more resistant to antibody-mediated treatment than brain tissue plaque deposits, and that aducanumab can remove them. Blood vessels that said the evidence to suggest was inadequate. Doctors cited a previous clinical trial of another anti-amyloid antibody, ponezumab. It found that vascular function in CAA patients tended to worsen rather than improve after 3 months of drug injection.

From a safety perspective, a letter from Greenberg and his colleagues is the fact that amyloid-related imaging abnormalities (ARIA) have emerged as a major adverse event in patients enrolled in trials for aducanumab and other anti-amyloid antibody drugs. Was quoted. ARIA, which appears as bleeding or swelling of the brain and is detectable by MRI imaging, is hypothesized to be caused by CAA. Physicians are worried that these abnormalities can occur more often in patients treated with CAA than in the higher rates observed in patients treated for Alzheimer’s disease. It was that.

While discouraging off-label use of aducanumab, Greenberg distinguished patients diagnosed with cerebral amyloid angiopathy from those diagnosed with Alzheimer’s disease. “We are not in a position to prescribe patients with Alzheimer’s disease who also have a marker for CAA. Aportanumab“What we’re saying is that you shouldn’t prescribe drugs to treat CAA,” he says.