Efficacy and safety of donanemab in the European eligible population: TRAILBLAZER-ALZ 2 post-hoc analyses - PubMed

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Donanemab significantly slowed disease progression in the EU-eligible population (non-carriers or heterozygotes of apolipoprotein E ε4 without specific contraindications) compared to placebo.
At 76 weeks, donanemab-treated participants showed a -0.7-point mean difference in CDR-Sum of Boxes change from baseline and a 40.3% lower risk of disease progression.
Treatment benefits increased over 154 weeks for non-carriers and heterozygotes, including those who completed the amyloid-based treatment course by 52 or 76 weeks.
Safety profile was manageable, with amyloid-related imaging abnormalities-edema/effusion in 19.5% and infusion-related reactions in 8.0% of eligible participants during the placebo-controlled period.
Post-hoc analyses used a conservative hybrid imputation method for efficacy and included comparisons with a propensity-weighted external control during the long-term extension phase.

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