Patients who received a modified schedule of the Alzheimer’s treatment Aduhelm (aducanumab) did not show signs of brain imaging abnormalities, according to a small review of data from a New York City neurology practice.
Aduhelm is a monoclonal antibody that targets and reduces amyloid beta brain plaques, which have been linked to Alzheimer’s disease and its symptoms. A potential side effect of drugs in its class is the development of adverse amyloid-related imaging abnormalities (ARIA) such as edema, swelling caused by excess fluid. Patients must be regularly scanned during treatment to watch for signs of this and other undesirable side effects.
Mitigating side effects
Noting the lack of available reports on using aducanumab in the clinical setting, a New York City neurology clinic reviewed side effect and tolerability data from 20 patients with Alzheimer’s diagnoses after treatment with aducanumab. With an eye to preventing ARIA, the clinic had opted to try a slower titration schedule in its patients (gradually increasing dosages), rather than following the schedule used in the drugmakers’ pivotal trials.
No patients developed clinically apparent ARIA, as confirmed in 16 with available post-treatment brain scans, reported the review’s sole author Gayatri Devi MD, MS, in the Journal of the American Geriatrics Society. Two patients complained of transient headaches, he noted. The study is unique in that there were no available reports on using aducanumab in a clinical setting at the time the study was written up, Devi said.
Slower titration
The theory behind the clinic’s slower titration schedule was that the positive action of Aduhelm — brain plaque dissolution — may exacerbate ARIA if it happens rapidly, Devi explained. At the time the published paper was written, 16 of the 20 patients had completed at least 8 infusions and had at least one MRI, and 10 patients had completed at least 12 infusions and had two MRIs. The average dose was 3 mg/kg (range 1–6 mg/kg) at that time.
The anti-amyloid Alzheimer’s treatment drug Aduhelm (aducanumab) has had a rough ride after being approved by the Food and Drug Administration in 2021. Indications are that a relatively small number of neurologists have tried the drug in the clinical setting, likely due to its expense and uncertainties about its risk-benefit profile, among other considerations.
“ARIA is a major clinical concern for physicians and patients considering anti-amyloid therapies for AD, notwithstanding debate about clinical efficacy,” Devi wrote. “Careful screening and a slower titration schedule may be useful in reducing the incidence of ARIA in the clinical use of drugs of this class,” he concluded.
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