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":3,"journal":{"name":"ACS Applied Electronic Materials","volume":null,"pages":null},"PeriodicalIF":4.3000,"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\":3,\"journal\":{\"name\":\"ACS Applied Electronic Materials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.3000,\"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\":\"ACS Applied Electronic Materials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848241239547\",\"RegionNum\":3,\"RegionCategory\":\"材料科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"ENGINEERING, ELECTRICAL & ELECTRONIC\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Electronic Materials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848241239547","RegionNum":3,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"ENGINEERING, ELECTRICAL & ELECTRONIC","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.
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