How quickly does Kisunla start working?

In the TRAILBLAZER-ALZ 2 Kisunla study with 1,736 people, those with the least advanced disease experienced the strongest outcomes, with a 35% slowing of cognitive and functional decline at 76 weeks on the Integrated Alzheimer’s Disease Rating Scale (iADRS), a tool which measures memory, thinking, and daily functioning.

People with mild cognitive impairment or a mild dementia stage of Alzheimer's disease were included in the study. People who were more advanced in early symptomatic Alzheimer's disease symptoms had a lower response to treatment.

The overall population, which included people with more advanced symptoms, had a 22% slowing on the iADRS score, with both groups showing a 39% lower risk of progressing to the next clinical stage of disease.

Does Kisunla reduce amyloid plaques?

Amyloid is a protein found in the body that can create plaques in the brain that may lead to memory and thinking issues associated with Alzheimer's disease. In the TRAILBLAZER-ALZ 2 study, treatment was continued or stopped based on how Kisunla affected amyloid imaging as seen on positron emission tomography (PET) imaging scans of the brain.

PET imaging scans in the overall population showed that Kisunla reduced amyloid plaques by an average of 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.

After researchers looked at amyloid PET levels, some patients were able to switch to a placebo (an inactive agent, which meant they were eligible to stop Kisunla treatment). The percentages of patients eligible for a switch to placebo was 17% at week 24, 47% at week 24 and 69% at week 76.

Related questions

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What common side effects were seen in Kisunla studies?

The Kisunla label carries a Boxed Warning for amyloid-related imaging abnormalities (ARIA), such as edema (ARIA-E), microhemorrhage (ARIA-H microhemorrhage) and superficial siderosis (ARIA-H superficial siderosis).

ARIA is seen from magnetic resonance imaging (MRI) scans of the brain and may present as temporary swelling or small spots of bleeding in or on the brain surface. ARIA does not usually cause symptoms, although serious, life-threatening and fatal events can rarely occur.

The most common side effects seen in the TRAILBLAZER-ALZ 2 study were:

• ARIA-E (24% vs. 2% placebo)
• ARIA-H microhemorrhage (25% vs. 11% placebo)
• ARIA-H superficial siderosis (15% vs. 3% placebo)
• headache (13% vs. 10% placebo)
• infusion-related reaction (9% vs. 0.5% placebo).

Use caution with use of antithrombotic drugs or in patients who are ApoE ε4 homozygotes.

This is not all the information you need to know about Kisunla (donanemab-azbt) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.