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Anti-Amyloid Beta Plaque Monoclonal Antibody

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Anti-Amyloid Beta Plaque Monoclonal Antibody, Humanized Immunoglobulin Gamma 1 Monoclonal Antibody, Aducanumab, Aduhelm, Lecanemab, Leqembi, Donanemab, Kisunla

  • See Also
  1. Dementia Management
  • Indications
  1. Alzheimer's Disease with Amyloid Beta Plaque
  • Mechanism
  1. Selectively bind amyloid beta Plaques in the CNS
  • Precautions
  1. Aducanumab, the prototype, was FDA approved in 2021 with much controversy
    1. FDA over-rode its own advisory committee's vote (10 against and 1 in favor) to not approve
  2. Lecanemab was FDA approved via the accelerated approval pathway in 2023, with little better evidence
  • Medications
  1. Aducanumab (Aduhelm)
    1. Monoclonal Antibody infused IV every 4 weeks at a cost of $28,200 to $56,000 per year
    2. Infused over 45 to 60 minutes
      1. Start: 1 mg/kg for first 2 infusions
      2. Next: 3 mg/kg for next 2 infusions
      3. Next: 6 mg/kg for next 2 infusions
      4. Then: 10 mg/kg for maintenance
  2. Lecanemab (Leqembi)
    1. Monoclonal Antibody infused IV every 2 weeks at a cost of $26,500 per year
    2. Infusion dose: 10 mg/kg over 60 minutes
  3. Donanemab (Kisunla)
    1. Infused IV weekly over 30 minutes starting at 700 mg for the first 3 weeks, then increase to 1400 mg
  • Efficacy
  1. May reduce amyloid beta Plaque, but does not appear to improve cognitive function
  2. No significant clinically meaningful benefit, high risk of harm, and at cost >$20,000 per year
    1. Ebell (2024) Ann Fam Med 22(1): 50-62 [PubMed]
  • Adverse Effects
  1. Risk of CNS microhemorrhages and edema (NNH 13)
    1. Requires 3 MRIs in first 12 to 18 months of use
  • References
  1. (2023) Presc Lett 30(4): 24
  2. (2021) Presc Lett 28(8): 43
  3. Walsh (2021) BMJ 374:n1682 [PubMed]