{"title":"lecanemab和donanemab治疗效果的性别差异：CLARITY-AD和TRAILBLAZER-ALZ2的贝叶斯再分析","authors":"Stefan J. Teipel, Yi Tang, Ara Khachaturian","doi":"10.1002/trc2.70155","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> INTRODUCTION</h3>\n \n <p>This study investigated evidence for or against a difference in treatment effect between women and men for lecanemab and donanemab.</p>\n </section>\n \n <section>\n \n <h3> METHODS</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> RESULTS</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> DISCUSSION</h3>\n \n <p>A better understanding of sex differences in treatment efficacy and their causes is urgently needed.</p>\n </section>\n \n <section>\n \n <h3> Highlights</h3>\n \n <div>\n <ul>\n \n <li>Lecanemab was six times more likely to be ineffective than effective in women.</li>\n \n <li>There was no evidence of a difference between the sexes in the effect of donanemab.</li>\n \n <li>Lecanemab and donenamb differed in treatment efficacy in women but not in men.</li>\n \n <li>Future trials should include sufficient power for sex related interaction effects.</li>\n </ul>\n </div>\n </section>\n </div>","PeriodicalId":53225,"journal":{"name":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","volume":"11 3","pages":""},"PeriodicalIF":6.8000,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://alz-journals.onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70155","citationCount":"0","resultStr":"{\"title\":\"Sex differences in treatment effects of lecanemab and donanemab: A Bayesian reanalysis of CLARITY-AD and TRAILBLAZER-ALZ2\",\"authors\":\"Stefan J. Teipel, Yi Tang, Ara Khachaturian\",\"doi\":\"10.1002/trc2.70155\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> INTRODUCTION</h3>\\n \\n <p>This study investigated evidence for or against a difference in treatment effect between women and men for lecanemab and donanemab.</p>\\n </section>\\n \\n <section>\\n \\n <h3> METHODS</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> RESULTS</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> DISCUSSION</h3>\\n \\n <p>A better understanding of sex differences in treatment efficacy and their causes is urgently needed.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Highlights</h3>\\n \\n <div>\\n <ul>\\n \\n <li>Lecanemab was six times more likely to be ineffective than effective in women.</li>\\n \\n <li>There was no evidence of a difference between the sexes in the effect of donanemab.</li>\\n \\n <li>Lecanemab and donenamb differed in treatment efficacy in women but not in men.</li>\\n \\n <li>Future trials should include sufficient power for sex related interaction effects.</li>\\n </ul>\\n </div>\\n </section>\\n </div>\",\"PeriodicalId\":53225,\"journal\":{\"name\":\"Alzheimer''s and Dementia: Translational Research and Clinical Interventions\",\"volume\":\"11 3\",\"pages\":\"\"},\"PeriodicalIF\":6.8000,\"publicationDate\":\"2025-09-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://alz-journals.onlinelibrary.wiley.com/doi/epdf/10.1002/trc2.70155\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Alzheimer''s and Dementia: Translational Research and Clinical Interventions\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70155\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Alzheimer''s and Dementia: Translational Research and Clinical Interventions","FirstCategoryId":"1085","ListUrlMain":"https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70155","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Sex differences in treatment effects of lecanemab and donanemab: A Bayesian reanalysis of CLARITY-AD and TRAILBLAZER-ALZ2
INTRODUCTION
This study investigated evidence for or against a difference in treatment effect between women and men for lecanemab and donanemab.
METHODS
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.
RESULTS
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.
DISCUSSION
A better understanding of sex differences in treatment efficacy and their causes is urgently needed.
Highlights
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.
期刊介绍：
Alzheimer''s & Dementia: Translational Research & Clinical Interventions (TRCI) is a peer-reviewed, open access,journal from the Alzheimer''s Association®. The journal seeks to bridge the full scope of explorations between basic research on drug discovery and clinical studies, validating putative therapies for aging-related chronic brain conditions that affect cognition, motor functions, and other behavioral or clinical symptoms associated with all forms dementia and Alzheimer''s disease. The journal will publish findings from diverse domains of research and disciplines to accelerate the conversion of abstract facts into practical knowledge: specifically, to translate what is learned at the bench into bedside applications. The journal seeks to publish articles that go beyond a singular emphasis on either basic drug discovery research or clinical research. Rather, an important theme of articles will be the linkages between and among the various discrete steps in the complex continuum of therapy development. For rapid communication among a multidisciplinary research audience involving the range of therapeutic interventions, TRCI will consider only original contributions that include feature length research articles, systematic reviews, meta-analyses, brief reports, narrative reviews, commentaries, letters, perspectives, and research news that would advance wide range of interventions to ameliorate symptoms or alter the progression of chronic neurocognitive disorders such as dementia and Alzheimer''s disease. The journal will publish on topics related to medicine, geriatrics, neuroscience, neurophysiology, neurology, psychiatry, clinical psychology, bioinformatics, pharmaco-genetics, regulatory issues, health economics, pharmacoeconomics, and public health policy as these apply to preclinical and clinical research on therapeutics.
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