New data from Eli Lilly indicates that a modified dosing regimen for its Alzheimer's drug, Kisunla, is associated with a reduced incidence of brain swelling, a common side effect known as ARIA-E (Amyloid-Related Imaging Abnormalities-Edema). The findings, presented at the Clinical Trials on Alzheimer's Disease annual conference in Madrid, suggest a potentially safer approach to administering the drug.
Reduced ARIA-E Incidence
The Phase 3b trial results revealed that at 24 weeks, 24% of patients on the standard Kisunla dosing regimen experienced ARIA-E. In contrast, only 14% of patients receiving the modified dosing schedule exhibited this side effect. This difference represents a 41% reduction in the risk of ARIA-E with the adjusted dosing strategy.
Impact on APOE4 Homozygotes
Researchers also examined the effects of the modified dosing on individuals carrying two copies of the APOE4 gene (APOE4 homozygotes), a population known to be at higher risk for ARIA-E. Among APOE4 homozygotes on the standard regimen, 57% developed ARIA-E, while only 19% of those on the modified regimen did. This translates to a 67% risk reduction in ARIA-E for this high-risk group.
Implications for Clinical Practice
While the data suggest a potential improvement in the safety profile of Kisunla, it remains to be seen whether the modified dosing schedule will reassure physicians concerned about ARIA-E. The ultimate impact on clinical practice will depend on regulatory approval of the new dosing strategy and further real-world evidence.
