Whitfield L Knapple, David S Yoho, Alexander Sheh, Joan Thul, Paul Feuerstadt
{"title":"粪便微生物群、活体-jslm (REBYOTA®) 结肠镜检查预防艰难梭菌感染复发的回顾性亚组分析。","authors":"Whitfield L Knapple, David S Yoho, Alexander Sheh, Joan Thul, Paul Feuerstadt","doi":"10.1177/17562848241239547","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Fecal microbiota, live-jslm (RBL; REBYOTA<sup>®</sup>), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing <i>Clostridioides difficile</i> infection (CDI) recurrence. Alternative routes of administration are of clinical interest.</p><p><strong>Objectives: </strong>Evaluate the safety and efficacy of RBL administration <i>via</i> colonoscopy.</p><p><strong>Design: </strong>Retrospective analysis of electronic medical records of participants administered RBL <i>via</i> colonoscopy under FDA enforcement discretion.</p><p><strong>Methods: </strong>The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence of CDI recurrence within 8 weeks and 6 months, respectively, were evaluated.</p><p><strong>Results: </strong>TEAEs were experienced by 75% (6/8) of participants; most were mild to moderate in severity, and none due to RBL or its administration. Most participants had treatment success (80%; 8/10); 75% (6/8) had sustained clinical response.</p><p><strong>Conclusion: </strong>Real-world safety and efficacy of RBL administered <i>via</i> colonoscopy were consistent with clinical trials of rectally administered RBL.</p><p><strong>Graphical abstract: </strong></p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.9000,"publicationDate":"2024-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962041/pdf/","citationCount":"0","resultStr":"{\"title\":\"Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA<sup>®</sup>) administered by colonoscopy under enforcement discretion for the prevention of recurrent <i>Clostridioides difficile</i> infection.\",\"authors\":\"Whitfield L Knapple, David S Yoho, Alexander Sheh, Joan Thul, Paul Feuerstadt\",\"doi\":\"10.1177/17562848241239547\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Fecal microbiota, live-jslm (RBL; REBYOTA<sup>®</sup>), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing <i>Clostridioides difficile</i> infection (CDI) recurrence. Alternative routes of administration are of clinical interest.</p><p><strong>Objectives: </strong>Evaluate the safety and efficacy of RBL administration <i>via</i> colonoscopy.</p><p><strong>Design: </strong>Retrospective analysis of electronic medical records of participants administered RBL <i>via</i> colonoscopy under FDA enforcement discretion.</p><p><strong>Methods: </strong>The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence of CDI recurrence within 8 weeks and 6 months, respectively, were evaluated.</p><p><strong>Results: </strong>TEAEs were experienced by 75% (6/8) of participants; most were mild to moderate in severity, and none due to RBL or its administration. Most participants had treatment success (80%; 8/10); 75% (6/8) had sustained clinical response.</p><p><strong>Conclusion: </strong>Real-world safety and efficacy of RBL administered <i>via</i> colonoscopy were consistent with clinical trials of rectally administered RBL.</p><p><strong>Graphical abstract: </strong></p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2024-03-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962041/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848241239547\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 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/10.1177/17562848241239547","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection.
Background: Fecal microbiota, live-jslm (RBL; REBYOTA®), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing Clostridioides difficile infection (CDI) recurrence. Alternative routes of administration are of clinical interest.
Objectives: Evaluate the safety and efficacy of RBL administration via colonoscopy.
Design: Retrospective analysis of electronic medical records of participants administered RBL via colonoscopy under FDA enforcement discretion.
Methods: The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence of CDI recurrence within 8 weeks and 6 months, respectively, were evaluated.
Results: TEAEs were experienced by 75% (6/8) of participants; most were mild to moderate in severity, and none due to RBL or its administration. Most participants had treatment success (80%; 8/10); 75% (6/8) had sustained clinical response.
Conclusion: Real-world safety and efficacy of RBL administered via colonoscopy were consistent with clinical trials of rectally administered RBL.
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.
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