Treatment Duration for Kisunla (Donanemab) in Alzheimer's Disease
Kisunla (donanemab) should be administered until amyloid clearance is demonstrated by amyloid PET, typically obtained after 12-18 months of treatment. 1
Patient Selection and Treatment Protocol
Kisunla is an IgG1 monoclonal antibody targeting N-terminal pyroglutamate-modified forms of amyloid-β, approved for treatment of early symptomatic Alzheimer's disease. Before initiating treatment, consider:
Appropriate candidates include persons with:
- Mild cognitive impairment or mild dementia due to AD (Clinical Stages 3-4)
- MMSE scores of 20-30
- Biomarker confirmation of AD pathology by PET or CSF 1
Pre-treatment requirements:
- APOE genotyping to assess risk for Amyloid-Related Imaging Abnormalities (ARIA)
- Pre-treatment MRI within 12 months before starting therapy
- Exclusion of patients with >4 cerebral microbleeds, cortical superficial siderosis, or major vascular contribution to cognitive impairment 1
Administration and Monitoring Schedule
Kisunla is administered as a monthly intravenous infusion with the following monitoring protocol:
- Surveillance MRIs to evaluate for ARIA should be performed:
- Prior to the 2nd, 3rd, 4th, and 7th infusions
- Prior to the 12th dose in higher-risk individuals
- Any time ARIA is clinically suspected 1
Treatment Duration Determination
The treatment duration is guided by amyloid clearance rather than a fixed timeframe:
- Clinicians should consider discontinuing treatment when amyloid clearance is demonstrated by amyloid PET
- This typically occurs after 12-18 months of treatment 1
- Treatment is not intended to be lifelong but rather until the therapeutic target of amyloid clearance is achieved
Important Safety Considerations
- ARIA is a significant side effect that requires careful monitoring
- The medication is administered as part of a shared decision-making process that emphasizes the patient's values and goals of care
- Regular cognitive assessments should be performed to evaluate clinical response
Clinical Pearls
- Tau PET is not required for eligibility determination
- Treatment duration is individualized based on amyloid clearance rather than a fixed duration
- The goal is to reduce amyloid burden sufficiently to impact disease progression
- Regular monitoring for side effects, particularly ARIA, is essential throughout the treatment course
This approach to Kisunla treatment duration focuses on achieving the therapeutic target of amyloid clearance while minimizing the risk of adverse effects, optimizing both safety and efficacy for patients with early Alzheimer's disease.