Teipel Stefan J, Tang Yi, Khachaturian Ara
German Center of Neurodegenerative Diseases (DZNE) Rostock/Greifswald Rostock Germany.
Department of Psychosomatic Medicine University Medicine Rostock Rostock Germany.
Alzheimers Dement (N Y). 2025 Sep 5;11(3):e70155. doi: 10.1002/trc2.70155. eCollection 2025 Jul-Sep.
This study investigated evidence for or against a difference in treatment effect between women and men for lecanemab and donanemab.
Data were derived from supplementary analyses of the regulatory studies CLARITY-AD (lecanemab) and TRAILBLAZER-ALZ2 (donanemab). Bayes factor functions were used to analyze treatment effects on Clinical Dementia Rating Sum of Boxes (CDR-SB) scores.
We found moderate evidence of a lower treatment effect in women than in men for lecanemab (maximum Bayes factor = 5.97), suggesting that the presence of an effect was almost six times more likely than the absence of an effect. For donanemab, there was evidence against a treatment effect difference between women and men. There was evidence of a treatment effect difference between lecanemab and donanemab (maximum Bayes factor = 8.47) in women, but not in men.
A better understanding of sex differences in treatment efficacy and their causes is urgently needed.
Lecanemab was six times more likely to be ineffective than effective in women.There was no evidence of a difference between the sexes in the effect of donanemab.Lecanemab and donenamb differed in treatment efficacy in women but not in men.Future trials should include sufficient power for sex related interaction effects.
本研究调查了在使用lecanemab和donanemab治疗时，女性和男性之间治疗效果是否存在差异的证据。
数据来源于监管研究CLARITY - AD（lecanemab）和TRAILBLAZER - ALZ2（donanemab）的补充分析。使用贝叶斯因子函数分析对临床痴呆评定量表框总和（CDR - SB）评分的治疗效果。
我们发现有中等证据表明，使用lecanemab治疗时，女性的治疗效果低于男性（最大贝叶斯因子 = 5.97），这表明存在治疗效果的可能性几乎是不存在治疗效果的六倍。对于donanemab，没有证据表明女性和男性之间的治疗效果存在差异。有证据表明lecanemab和donanemab在女性中存在治疗效果差异（最大贝叶斯因子 = 8.47），但在男性中没有。
迫切需要更好地了解治疗效果中的性别差异及其原因。
在女性中，lecanemab无效的可能性是有效的六倍。没有证据表明donanemab的治疗效果在性别上存在差异。Lecanemab和donenamb在女性中的治疗效果不同，但在男性中没有。未来的试验应具备足够的能力来检测与性别相关的相互作用效应。
