Aducanumab Treatment for 2 Years or More Decreases Amyloid Beta and Phosphorylated Tau 181 Correlating With Reduced Cognitive Decline
New data show continued reductions in amyloid β (Aβ) plaques and plasma levels of phosphorylated tau 181 (ptau-181) after 128 weeks of treatment with aducanumab (Aduhelm; Biogen, Cambridge, MA). Participants with greater decreases in Aβ were more likely to have decreased in p-tau181. Those who had decreases in ptau-181 levels had less cognitive decline that those whose ptau-181 levels did not decrease.
Cognitive decline was measured with the Clinical Dementia Rating-Sum of Boxes (CDR-SB), Mini-Mental State Exam (MMSE), Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13), and Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI), and decreased cognitive decline was seen in all 4 measures in those with lower ptau-181 levels.
“These are meaningful findings, which further our understanding of amyloid and downstream biomarkers, such as p-tau 181, in Alzheimer’s disease and can help inform how long patients may benefit from treatment to reduce amyloid beta plaque,” said Samantha Budd Haeberlein, Ph.D., SVP, Head of Neurodegeneration Development at Biogen. “These data demonstrate that long-term treatment with ADUHELM continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years."
Detailed data from the clinical trials of aducanumab have now been published in a peer-reviewed journal, The Journal of Prevention of Alzheimer’s Disease (JPAD), including results on primary, secondary and tertiary endpoints, biomarker substudies, and safety data.
“We are pleased that the peer-reviewed manuscript is now available to provide physicians with a greater understanding of the appropriate use of ADUHELM,” said Samantha Budd Haeberlein, Ph.D., SVP, Head of Neurodegeneration Development at Biogen. “We will continue to provide physicians with efficacy and safety data to help them make the best treatment decisions for patients as we learn from our ongoing trials and real-world evidence.”
In participants treated with 10 mg/kg aducanumab, the rate of amyloid-related imaging abnormality with effusion (ARIA-E) was 35.2%, which was higher in those with the apolipoprotein E (APOE) ε4 allele (43.0% vs 20.3%). ARIA is a serious side effect of swelling in the brain that can be asymptomatic but can also be serious, causing headache, altered mental status, nausea, vomiting, tremor, and gait disturbances.
These data were presented at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022), in Barcelona, Spain and virtually from March 15-20, 2022.