Disclosures: Day reports support by a career development grant from the NIH, ownership of stock in ANI Pharmaceuticals, serving as a topic editor for DynaMed and working as a consultant for Parabon Nanolabs Inc. and as an uncompensated clinical director of the Anti-NMDA Receptor Encephalitis Foundation.
March 01, 2022
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AAN guidelines subcommittee says more guidance needed for Aduhelm recommendations

Disclosures: Day reports support by a career development grant from the NIH, ownership of stock in ANI Pharmaceuticals, serving as a topic editor for DynaMed and working as a consultant for Parabon Nanolabs Inc. and as an uncompensated clinical director of the Anti-NMDA Receptor Encephalitis Foundation.
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Recommendations for Aduhelm require more guidance and an expanded clinical profile to address several issues that will aid in discussions between patients and providers, per a systematic review of clinical data published in Neurology.

“The approval of aducanumab marks a shift in AD therapeutics from medications targeting symptoms (eg, acetylcholinesterase inhibitors) to those targeting neuropathology associated with AD,” Gregory S. Day, MD, of the department of neurology at the Mayo Clinic, and colleagues wrote. “Whether aducanumab will result in a clinically meaningful slowing of AD symptoms remains to be determined, as does the safety of aducanumab in clinical populations.”

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To establish a proper body of evidence for use of Aduhelm (aducanumab, Biogen) in early-onset AD and present clinical considerations regarding its administration, Day and colleagues systematically reviewed data from four clinical trials (one was rated class I and three were class II). Researchers assigned level of evidence statements in accordance with the AAN 2017 therapeutic classification of evidence guidelines and also reviewed safety information, regulatory decisions and clinical context.

Results from the class I study showed single doses of aducanumab up to 30 mg/kg were safe and well tolerated. In addition, evidence from all class II studies indicated that 3 mg/kg to 10 mg/kg of aducanumab decreased amyloid deposits on brain PET scans at 1 year vs. placebo.

Efficacy data in the class II studies varied by dose and outcome, but aducanumab either had no effect on mean change of metrics related to disease progression or resulted in less worsening (vs. placebo), which was of variable clinical importance. In addition, adverse amyloid-related imaging abnormalities occurred in approximately 40% of patients treated with aducanumab vs. 10% who were given a placebo.

“More research is needed regarding many aspects of treatment with aducanumab, including studies to assess its use in people from underrepresented populations, to determine whether this drug is effective at slowing progression of Alzheimer’s disease, how often MRIs must be done to monitor for brain swelling and bleeding, the optimal duration of treatment, and the criteria for when to discontinue the drug,” Day said in a related press release.

Reference:

American Academy of Neurology. AAN issues evidence-in-focus article on aducanumab.

https://www.eurekalert.org/news-releases/943950. Published Feb. 23, 2002. Accessed March 1, 2022.