{"id":"doi:10.1016/j.tjpad.2026.100605","kind":"article","title":"Efficacy and safety of donanemab in the European eligible population: TRAILBLAZER-ALZ 2 post-hoc analyses","authors":["Jessen F","Dell'Agnello G","Zimmer JA","Sapin C","Dichter S","Doty E","Epelbaum S","Evans CD","Hauck PM","Khanna R","Brooks DA","Sims JR","Agosta F"],"author_count":13,"year":2026,"published":"2026-05-27","venue":"The journal of prevention of Alzheimer's disease","cited_by":2,"doi":"10.1016/j.tjpad.2026.100605","arxiv_id":null,"nct_id":null,"source_url":"https://doi.org/10.1016/j.tjpad.2026.100605","archive_url":"https://space-kitty.com/papers/doi:10.1016/j.tjpad.2026.100605","updated":null,"pmid":"42202469","pmcid":"PMC13234467","openalex_id":null,"pdf_url":"https://europepmc.org/articles/PMC13234467/pdf","abstract":"Background In the European Union (EU), donanemab is indicated in adults with early symptomatic Alzheimer's disease who are apolipoprotein E ε4 non-carriers or heterozygotes. Among these, patients without superficial siderosis at baseline, uncontrolled hypertension, or anticoagulant use are eligible. Objective To assess efficacy and safety of donanemab in the EU-eligible population. Methods A post-hoc conservative hybrid imputation method was implemented for clinical efficacy analyses during the TRAILBLAZER-ALZ 2 placebo-controlled period. In the 78-week long-term extension (LTE) participants in the early-start (randomised to donanemab) and delayed-start (randomised to placebo with donanemab initiation during the LTE) groups were compared to a propensity-weighted external control. Participants were switched to placebo after meeting amyloid-based treatment course completion criteria. Results By 76 weeks, donanemab-treated participants in the EU-eligible population had a mean Clinical Dementia Rating Scale (CDR)-Sum of Boxes change from baseline difference from placebo of -0.7 points (95% confidence interval, -1.0, -0.4) and a 40.3% lower risk of disease progression to the next stage (per CDR-Global score). Treatment benefit increased over 154 weeks for non-carriers and heterozygotes, including those meeting treatment course completion criteria by 52 or 76 weeks. In the placebo-controlled period, 119 (19.5%) and 49 (8.0%) donanemab-treated eligible participants experienced amyloid-related imaging abnormalities-edema/effusion and infusion-related reactions, respectively. Safety findings were similar among donanemab-treated participants in the placebo-controlled period and LTE delayed-start group. Conclusions Consistent with previous TRAILBLAZER-ALZ 2 and LTE findings, donanemab significantly slowed disease progression compared to controls with a manageable safety profile in non-carriers and heterozygotes.","abstract_license":"CC-BY (article license as recorded by Europe PMC; abstract reproduced unmodified apart from markup removal)","license":"CC-BY","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":[],"details":null,"provenance":"europepmc","attribution":"Abstract of \"Efficacy and safety of donanemab in the European eligible population: TRAILBLAZER-ALZ 2 post-hoc analyses\" by Jessen F, Dell'Agnello G, Zimmer JA et al., https://doi.org/10.1016/j.tjpad.2026.100605, used under its Creative Commons Attribution license (CC-BY); markup removed, otherwise unmodified.","topics":[{"slug":"neurodegeneration","name":"Alzheimer's, Parkinson's & Neurodegeneration","domain_slug":"medicine"}],"cited_in_dossiers":[]}