Summary

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• Kisunla (donanemab-azbt) is indicated for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials.
• This summary is based on the review of eight systematic review(s)/meta-analysis(es). ^[1-8]
• Cognitive Decline and Clinical Progression: Donanemab demonstrated moderate slowing of clinical progression in patients with amyloid pathology (SMD -0.239, 95% CI -0.343 to -0.134). Lecanemab showed similar effects with an SMD of -0.194 (95% CI -0.279 to -0.108). Both treatments showed higher efficacy on specific cognitive measures compared to placebo, but neither exceeded the minimal clinically important difference (MCID).
• Comparative Effectiveness: Donanemab, lecanemab, and aducanumab did not show significant differences in efficacy on cognitive function. Lithium may outperform aducanumab, though its relative efficacy compared to donanemab and lecanemab remains unclear.
• Adverse Events: Donanemab, lecanemab, and aducanumab were associated with increased risks of amyloid-related imaging abnormalities (ARIA)-edema (RR = 10.29; NNH = 9), ARIA-hemorrhage (RR = 1.74; NNH = 13), and symptomatic ARIA-edema (RR = 24.3; NNH = 86). Donanemab specifically exhibited ARIA-related adverse events in 26.1% to 30.5% of trial participants.
• Comparative Safety: Lithium was indicated as potentially safer compared to donanemab, lecanemab, and aducanumab, while angiotensin receptor blockers (ARBs) were found to be safer than monoclonal antibodies such as aducanumab and lecanemab.
• Older age and greater baseline cognitive impairment were associated with progression in early Alzheimer's disease; the APOE4 allele was identified as a predictive factor for treatment efficacy and adverse response (ARIA); elevated biomarkers (CSF/plasma p-tau, CSF t-tau, plasma neurofilament light) correlated with disease progression; trials predominantly involved adult patients with mild-to-moderate AD, including specific subgroups like those with amyloid pathology or carrying the APOE4 allele.