ArticleAlzheimer's & dementia (New York, N. Y.)
Infusion-related reactions in donanemab-treated participants with early symptomatic Alzheimer's disease.
Article in Alzheimer's & dementia (New York, N. Y.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 2 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments
A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease
Who cites it
2 citing papers in PubMed.
- Anti-Amyloid Monoclonal Antibodies in Early Alzheimer Disease: Lecanemab and Donanemab.Neurology international · 2026Review
- Transport pathways across the blood-brain barrier for waste clearance and drug delivery.Fluids and barriers of the CNS · 2026Review
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionInfusion-related reactions (IRRs) and hypersensitivity are adverse events associated with therapeutic antibodies. Characterization of IRRs can lead to improved risk anticipation and management of this event. This post hoc analysis characterizes IRRs in donanemab-treated participants with early symptomatic Alzheimer's disease (AD) from several multicenter studies.
methodsData were pooled from the donanemab-treated population from TRAILBLAZER-ALZ, TRAILBLAZER-ALZ 2, a stand-alone open-label addendum to TRAILBLAZER-ALZ 2, TRAILBLAZER-EXT, and TRAILBLAZER-ALZ 4. Descriptive statistics were used to characterize IRRs and related events. A random forest model identified potential association between IRRs and 40 baseline variables.
resultsOf 2727 donanemab-treated participants, 225 (8.3%) reported IRRs. Of 216 participants with immediate events, 122 (56.5%) were mild and 83 (38.4%) were moderate. Thirteen (0.5%) participants reported a serious event. Of IRRs occurring on the day of infusion, 87.8% occurred during or within 30 min after infusion. Of donanemab-treated participants with IRRs, 194 (77.0%) reported their first IRR by the fourth infusion. The most common symptoms reported within 24 h of infusion were nausea/vomiting (3.5%), chills (3.3%), and erythema (3.1%). In an exploratory analysis, 11/29 (37.9%) participants with at least one laboratory value taken after IRR and related events, as well as a corresponding baseline value, had elevated tryptase levels after IRR; events were of moderate severity in 82% of these participants versus 44% of those without tryptase elevations. Of donanemab-treated participants who previously experienced an IRR, 164 (65.1%) received a rechallenge infusion. Prophylaxis medication (primarily antihistamines) was used at rechallenge in 38 (23.2%) of rechallenged participants but did not reduce IRR risk. Machine learning models identified previous drug allergy and previous anaphylaxis as significant predictors of IRRs ( DISCUSSION: IRRs are a common occurrence with donanemab treatment. The majority of IRRs among donanemab-treated participants were mild to moderate, and rechallenge was often tolerated. Serious IRRs and anaphylaxis were reported.Trial Registration: NCT03367403; NCT04437511, NCT04640077, NCT05108922.
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