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Aducanumab
Answer
Clinical efficacy of Aducanumab in Alzheimer's disease: Aducanumab is a humanised monoclonal antibody targeting aggregated amyloid beta plaques in the brain, aiming to modify disease pathology in early Alzheimer's disease. Phase 3 randomized trials (EMERGE and ENGAGE) have shown that Aducanumab can reduce amyloid plaque burden, with some evidence of slowing cognitive decline in early Alzheimer's disease, although the magnitude of clinical benefit is modest and remains controversial (Budd Haeberlein et al., 2022; Thussu et al., 2024).
Safety profile: Aducanumab treatment is associated with amyloid-related imaging abnormalities (ARIA), including edema and microhemorrhages, which require monitoring. Other adverse events include headache, infusion-related reactions, and falls. The safety concerns necessitate specialist supervision and careful patient selection (Thussu et al., 2024).
UK guideline context: Current UK NICE guidelines for dementia management do not recommend Aducanumab for routine clinical use due to insufficient evidence of meaningful clinical efficacy and concerns about safety and cost-effectiveness. Instead, they recommend acetylcholinesterase inhibitors and memantine for symptomatic management of mild to severe Alzheimer's disease, which have demonstrated modest but clinically detectable benefits on cognition and function 1.
Integration: While Aducanumab represents a novel amyloid beta-directed therapy with potential disease-modifying effects, its clinical efficacy is limited and safety risks significant. UK guidelines prioritize treatments with established benefit and safety profiles, reflecting the current evidence base. Recent literature acknowledges Aducanumab’s amyloid clearance but highlights the need for further robust evidence to confirm meaningful clinical outcomes and to better define its risk-benefit ratio (Budd Haeberlein et al., 2022; Thussu et al., 2024; 1).
Key References
- CKS - Dementia
- Donanemab SmPC
- Lecanemab SmPC
- NG97 - Dementia: assessment, management and support for people living with dementia and their carers
- Adalimumab SmPC
- Eculizumab SmPC
- Agalsidase beta SmPC
- (Budd Haeberlein et al., 2022): Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer's Disease.
- (Vitek et al., 2023): Lecanemab (BAN2401): an anti-beta-amyloid monoclonal antibody for the treatment of Alzheimer disease.
- (Thussu et al., 2024): Profiling aducanumab as a treatment option for Alzheimer's disease: an overview of efficacy, safety and tolerability.
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