Yuting Wang, Shiyuan Lu, Wen Hu, Shuyan Li, Yan Chen
{"title":"克罗恩病静脉注射ustekinumab维持：一项单中心回顾性队列研究","authors":"Yuting Wang, Shiyuan Lu, Wen Hu, Shuyan Li, Yan Chen","doi":"10.1177/17562848251375356","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Despite the established efficacy of ustekinumab (UST) in Crohn's disease (CD), real-world studies reveal suboptimal treatment persistence and limited endoscopic healing. Current optimization paradigms remain constrained by suboptimal durability and escalating therapeutic demands.</p><p><strong>Objectives: </strong>To evaluate the clinical utility and safety of intravenous (IV) ustekinumab maintenance therapy in CD.</p><p><strong>Design: </strong>This was a single-center retrospective cohort study.</p><p><strong>Methods: </strong>This study included CD patients receiving ⩾2 IV-UST maintenance infusions between June 2020 and October 2023 (<i>N</i> = 234). The protocol featured weight-based induction-equivalent dosing (260-520 mg) at response-guided intervals. The primary endpoint was the corticosteroid-free clinical remission rate at Week 24.</p><p><strong>Results: </strong>At 24 weeks, 88.1% (185/210) achieved steroid-free remission with C-reactive protein (CRP) normalization in 90.0% (44/88). Median Harvey-Bradshaw Index decreased from 4 (interquartile range (IQR) 2-5) to 2 (IQR 1-3; <i>p</i> < 0.001). 52-week endoscopic remission (simplified endoscopic score for Crohn's disease ⩽3) reached 48.7% (56/115), with fecal calprotectin normalization in 33.6% (35/104). Multivariate analysis identified baseline CRP >5 mg/L (adjusted odds ratio (aOR) 3.62, 1.16-11.25), intensive dosing (⩾6 cycles/year; aOR 12.06, 1.99-73.05), and disease duration ⩾1 year (aOR 3.53, 1.08-11.54) as predictors of endoscopic non-remission. Safety analysis demonstrated 44.4% adverse event incidence (104/234) and 3.0% serious adverse events (7/234).</p><p><strong>Conclusion: </strong>IV-UST maintenance demonstrates high rates of corticosteroid-free clinical remission and endoscopic healing with manageable safety in CD.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251375356"},"PeriodicalIF":3.4000,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497971/pdf/","citationCount":"0","resultStr":"{\"title\":\"Intravenous ustekinumab maintenance in Crohn's disease: a single-center retrospective cohort study.\",\"authors\":\"Yuting Wang, Shiyuan Lu, Wen Hu, Shuyan Li, Yan Chen\",\"doi\":\"10.1177/17562848251375356\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Despite the established efficacy of ustekinumab (UST) in Crohn's disease (CD), real-world studies reveal suboptimal treatment persistence and limited endoscopic healing. Current optimization paradigms remain constrained by suboptimal durability and escalating therapeutic demands.</p><p><strong>Objectives: </strong>To evaluate the clinical utility and safety of intravenous (IV) ustekinumab maintenance therapy in CD.</p><p><strong>Design: </strong>This was a single-center retrospective cohort study.</p><p><strong>Methods: </strong>This study included CD patients receiving ⩾2 IV-UST maintenance infusions between June 2020 and October 2023 (<i>N</i> = 234). The protocol featured weight-based induction-equivalent dosing (260-520 mg) at response-guided intervals. The primary endpoint was the corticosteroid-free clinical remission rate at Week 24.</p><p><strong>Results: </strong>At 24 weeks, 88.1% (185/210) achieved steroid-free remission with C-reactive protein (CRP) normalization in 90.0% (44/88). Median Harvey-Bradshaw Index decreased from 4 (interquartile range (IQR) 2-5) to 2 (IQR 1-3; <i>p</i> < 0.001). 52-week endoscopic remission (simplified endoscopic score for Crohn's disease ⩽3) reached 48.7% (56/115), with fecal calprotectin normalization in 33.6% (35/104). Multivariate analysis identified baseline CRP >5 mg/L (adjusted odds ratio (aOR) 3.62, 1.16-11.25), intensive dosing (⩾6 cycles/year; aOR 12.06, 1.99-73.05), and disease duration ⩾1 year (aOR 3.53, 1.08-11.54) as predictors of endoscopic non-remission. Safety analysis demonstrated 44.4% adverse event incidence (104/234) and 3.0% serious adverse events (7/234).</p><p><strong>Conclusion: </strong>IV-UST maintenance demonstrates high rates of corticosteroid-free clinical remission and endoscopic healing with manageable safety in CD.</p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":\"18 \",\"pages\":\"17562848251375356\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-10-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497971/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251375356\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251375356","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Intravenous ustekinumab maintenance in Crohn's disease: a single-center retrospective cohort study.
Background: Despite the established efficacy of ustekinumab (UST) in Crohn's disease (CD), real-world studies reveal suboptimal treatment persistence and limited endoscopic healing. Current optimization paradigms remain constrained by suboptimal durability and escalating therapeutic demands.
Objectives: To evaluate the clinical utility and safety of intravenous (IV) ustekinumab maintenance therapy in CD.
Design: This was a single-center retrospective cohort study.
Methods: This study included CD patients receiving ⩾2 IV-UST maintenance infusions between June 2020 and October 2023 (N = 234). The protocol featured weight-based induction-equivalent dosing (260-520 mg) at response-guided intervals. The primary endpoint was the corticosteroid-free clinical remission rate at Week 24.
Results: At 24 weeks, 88.1% (185/210) achieved steroid-free remission with C-reactive protein (CRP) normalization in 90.0% (44/88). Median Harvey-Bradshaw Index decreased from 4 (interquartile range (IQR) 2-5) to 2 (IQR 1-3; p < 0.001). 52-week endoscopic remission (simplified endoscopic score for Crohn's disease ⩽3) reached 48.7% (56/115), with fecal calprotectin normalization in 33.6% (35/104). Multivariate analysis identified baseline CRP >5 mg/L (adjusted odds ratio (aOR) 3.62, 1.16-11.25), intensive dosing (⩾6 cycles/year; aOR 12.06, 1.99-73.05), and disease duration ⩾1 year (aOR 3.53, 1.08-11.54) as predictors of endoscopic non-remission. Safety analysis demonstrated 44.4% adverse event incidence (104/234) and 3.0% serious adverse events (7/234).
Conclusion: IV-UST maintenance demonstrates high rates of corticosteroid-free clinical remission and endoscopic healing with manageable safety in CD.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
