Tarun Chhibba, Karan Sachdeva, Ashwin N Ananthakrishnan
{"title":"炎症性肠病3期临床试验中肠外表现和疲劳的评估和报告。","authors":"Tarun Chhibba, Karan Sachdeva, Ashwin N Ananthakrishnan","doi":"10.1093/ecco-jcc/jjaf009","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) are frequently experienced by patients and may lead to severe symptoms and fatigue. However, the reporting patterns of these outcomes in IBD randomized controlled trials (RCTs) are not clear.</p><p><strong>Methods: </strong>We searched placebo-controlled phase 3 RCTs of advanced therapies in IBD and assessed the frequency and means of reporting EIM and fatigue data in these studies.</p><p><strong>Results: </strong>Thirty-three phase 3 RCTs for Crohn's disease (CD) (n = 16) or ulcerative colitis (UC) (n = 16) were identified between 2002 and 2023. While all trials (16/16) in CD collected some EIM data, we could only ascertain 6/16 (38%) collected EIM data in UC trials. Fewer than one-third (9/32, 28%) reported EIM prevalence at baseline; fewer reported the improvement with active treatment (9%). Fatigue was measured in 20/32 trials (63%).</p><p><strong>Conclusions: </strong>EIM and fatigue data are inconsistently collected in RCTs of IBD. Standardizing collection methods across RCTs would provide greater insight on these agents and their efficacy in treating these manifestations of disease.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Assessment and reporting of extraintestinal manifestations and fatigue in phase 3 inflammatory bowel disease clinical trials.\",\"authors\":\"Tarun Chhibba, Karan Sachdeva, Ashwin N Ananthakrishnan\",\"doi\":\"10.1093/ecco-jcc/jjaf009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) are frequently experienced by patients and may lead to severe symptoms and fatigue. However, the reporting patterns of these outcomes in IBD randomized controlled trials (RCTs) are not clear.</p><p><strong>Methods: </strong>We searched placebo-controlled phase 3 RCTs of advanced therapies in IBD and assessed the frequency and means of reporting EIM and fatigue data in these studies.</p><p><strong>Results: </strong>Thirty-three phase 3 RCTs for Crohn's disease (CD) (n = 16) or ulcerative colitis (UC) (n = 16) were identified between 2002 and 2023. While all trials (16/16) in CD collected some EIM data, we could only ascertain 6/16 (38%) collected EIM data in UC trials. Fewer than one-third (9/32, 28%) reported EIM prevalence at baseline; fewer reported the improvement with active treatment (9%). Fatigue was measured in 20/32 trials (63%).</p><p><strong>Conclusions: </strong>EIM and fatigue data are inconsistently collected in RCTs of IBD. Standardizing collection methods across RCTs would provide greater insight on these agents and their efficacy in treating these manifestations of disease.</p>\",\"PeriodicalId\":94074,\"journal\":{\"name\":\"Journal of Crohn's & colitis\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-01-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Crohn's & colitis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/ecco-jcc/jjaf009\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Crohn's & colitis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/ecco-jcc/jjaf009","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Assessment and reporting of extraintestinal manifestations and fatigue in phase 3 inflammatory bowel disease clinical trials.
Background: Extraintestinal manifestations (EIMs) of inflammatory bowel disease (IBD) are frequently experienced by patients and may lead to severe symptoms and fatigue. However, the reporting patterns of these outcomes in IBD randomized controlled trials (RCTs) are not clear.
Methods: We searched placebo-controlled phase 3 RCTs of advanced therapies in IBD and assessed the frequency and means of reporting EIM and fatigue data in these studies.
Results: Thirty-three phase 3 RCTs for Crohn's disease (CD) (n = 16) or ulcerative colitis (UC) (n = 16) were identified between 2002 and 2023. While all trials (16/16) in CD collected some EIM data, we could only ascertain 6/16 (38%) collected EIM data in UC trials. Fewer than one-third (9/32, 28%) reported EIM prevalence at baseline; fewer reported the improvement with active treatment (9%). Fatigue was measured in 20/32 trials (63%).
Conclusions: EIM and fatigue data are inconsistently collected in RCTs of IBD. Standardizing collection methods across RCTs would provide greater insight on these agents and their efficacy in treating these manifestations of disease.
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