A change in the dosing regimen of Eli Lilly’s Alzheimer’s drug Kisunla resulted in a lower rate of brain swelling among patients in a clinical trial, new data reported Tuesday show. But it’s unclear whether the new dosing schedule, if approved by regulators, will convince doctors that the treatment is safer for patients.
At 24 weeks of a Phase 3b trial, 24% of those taking the standard regimen experienced a side effect called ARIA-E, a kind of brain swelling. Meanwhile, 14% of those in the modified dosing groups had ARIA-E. That translated to a 41% risk reduction, according to the data, presented at the Clinical Trials on Alzheimer’s Disease annual conference in Madrid.
Researchers also looked specifically at people who carried two copies of a genetic variant called APOE4, or APOE4 homozygotes, which is a population that’s more likely to experience side effects from drugs like Kisunla. Among those taking the standard regimen, 57% experienced ARIA-E, while 19% of people in the modified dosing group did, representing a 67% lower risk.
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