Aducanumab-avwa

(Aduhelm®)

Aducanumab-avwa

Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 170 mg/1.7 mL, 300 mg/3 mL)
Drug ClassAmyloid beta-directed antibodies
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Alzheimer’s disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Summary
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  • Aducanumab-avwa (Aduhelm) is indicated for the treatment of Alzheimer's disease, specifically in patients with mild cognitive impairment or mild dementia stage. The medication demonstrates the potential in targeting the pathophysiology of Alzheimer’s by focusing on amyloid-beta plaques and decelerating cognitive decline.
  • Eighteen systematic reviews/meta-analyses were assessed to collect information about this medication. These evaluations concentrated on comparing monoclonal antibodies, including Aduhelm, for their effectiveness and safety implications in treating Alzheimer’s disease.
  • In comparison to other medications like Donanemab, Lecanemab, Gantenerumab, and Solanezumab, Aduhelm is distinguished by its significant reduction of amyloid-beta plaques, which correlates with improved clinical outcomes in AD patients.
  • It has been recognized that Aduhelm presents certain safety concerns related to Amyloid-related imaging abnormalities, such as edema (ARIA-E) and hemorrhage (ARIA-H), necessitating cautious patient selection and monitoring during therapy.
  • Regarding population considerations based on genetic characteristics such as Apolipoprotein E ε4 status (APOE ε4), studies suggest that both Aducanumab-avwa (Aduhelm) and Donanemab might offer slightly better efficacy among carriers, indicating a need for customizing therapies according to genetic factors.
  • Despite the risks associated with Amyloid-related imaging abnormalities (ARIA), evidence suggests that the benefit-to-risk ratio could be favorable, especially when robust risk management strategies are executed, including meticulous monitoring protocols, particularly among genetically predisposed populations who are at higher risk for adverse events like ARIA-E & H.
  • The effectiveness comparison indicates that while all monoclonal antibodies have some level of impact on slowing cognitive decline, Aducanumab-avwa (Aduhelm)'s direct influence on reducing beta-plaques sets it apart despite having comparable levels of improvement in cognitive functions as other leading monoclonal antibodies.
  • In conclusion, Aduhelm offers promise in terms of efficacy by addressing a fundamental pathophysiological aspect of Alzheimer's disease, yet it carries significant safety considerations requiring cautious patient selection and monitoring.

Product Monograph / Prescribing Information

Document TitleYearSource
Aduhelm (aducanumab-avwa) Prescribing Information.2023Biogen Inc., Cambridge, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy and safety of monoclonal antibodies for cognitive decline in patients with Alzheimer's disease: a systematic review and network meta-analysis.2024CNS Drugs
Bayesian meta-analysis of phase 3 results of aducanumab, lecanemab, donanemab, and high-dose gantenerumab in prodromal and mild Alzheimer's disease.2024Alzheimer's & Dementia
Prognostic and predictive factors in early alzheimer's disease: a systematic review.2024Journal of Alzheimer's Disease Reports
Comparative efficacy, tolerability and acceptability of donanemab, lecanemab, aducanumab and lithium on cognitive function in mild cognitive impairment and Alzheimer's disease: aA systematic review and network meta-analysis.2024Ageing Research Reviews
Clinically important benefits and harms of monoclonal antibodies targeting amyloid for the treatment of Alzheimer disease: aA systematic review and meta-analysis.2024Annals of Family Medicine
Aducanumab for the treatment of Alzheimer's disease: a systematic review.2023Psychogeriatrics
Immunotherapies targeting amyloid and Tau protein in Alzheimer’s disease: should we move away from diseases and focus on biological targets? A systematic review and expert opinion. 2023Neurology and Therapy
Comparative study of safety and efficacy of angiotensin-receptor blockers and anti amyloid-ß monoclonal antibodies for the treatment of alzheimer’s disease: a systematic review. 2023Cureus
Efficacy and safety of anti-amyloid-β monoclonal antibodies in current Alzheimer’s disease phase III clinical trials: A systematic review and interactive web app-based meta-analysis. 2023Ageing Research Reviews
APOE ε4's impact on response to amyloid therapies in early symptomatic Alzheimer's disease: Analyses from multiple clinical trials.2023Alzheimer's & Dementia: The Journal of The Alzheimer's Association
The FDA-approved anti-amyloid-β monoclonal antibodies for the treatment of Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials.2023European Journal of Medical Research
Comparative efficacy of lithium and aducanumab for cognitive decline in patients with mild cognitive impairment or Alzheimer’s disease: a systematic review and network meta-analysis.2022Ageing Research Reviews
Amyloid-related imaging abnormalities and β-amyloid-targeting antibodies: a systematic review.2022JAMA Neurology
High-clearance anti-amyloid immunotherapies in Alzheimer’s disease. Part 1: Meta-analysis and review of efficacy and safety data, and medico-economical aspects. 2022Revue Neurologique
Incidence of amyloid-related imaging abnormalities in patients with Alzheimer disease treated with anti-beta-amyloid immunotherapy: a meta-analysis.2022Neurology
Application of meta-analysis to evaluate relationships among aria-e rate, amyloid reduction rate, and clinical cognitive response in amyloid therapeutic clinical trials for early Alzheimer’s disease.2022Therapeutic Innovation & Regulatory Science
Past, present and future of therapeutic strategies against amyloid-β peptides in Alzheimer’s disease: a systematic review.2021Ageing Research Reviews
Effects of monoclonal antibodies against amyloid-β on clinical and biomarker outcomes and adverse event risks: a systematic review and meta-analysis of phase III RCTs in Alzheimer’s disease.2021Ageing Research Reviews

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