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TOPLINE:
Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and recurrent Clostridioides difficile infection (CDI), there›s no clear benefit to using both vs FMT alone.
METHODOLOGY:
- Researchers conducted a randomized placebo-controlled trial among 61 patients with IBD (20 with Crohn’s disease and 41 with ulcerative colitis) who had two or more episodes of CDI.
- All participants received a single colonoscopic FMT from a universal stool bank and were randomly assigned to receive a single bezlotoxumab infusion or placebo infusion before or at the time of the FMT.
- Patients were measured for CDI recurrence, defined as presence of diarrhea and positive glutamate dehydrogenase and enzyme immunoassay toxin test results, up to week 8 after treatment.
- Researchers also looked at C difficile decolonization, defined as absence of diarrhea and negative polymerase chain reaction (PCR) test results, and changes in IBD disease activity through week 12.
TAKEAWAY:
- Five participants (8%) had a CDI recurrence, including four who received bezlotoxumab and one who received placebo (13% vs 3%).
- Although participants in the treatment arm had higher odds of CDI recurrence, the difference wasn’t statistically significant.
- More patients who received bezlotoxumab were decolonized compared to placebo, both at week 1 (82% vs 68%) and week 12 (83% vs 72%), though the difference wasn’t statistically significant.
- There weren’t any significant differences in IBD outcomes, although there were higher rates of IBD improvement among those who received bezlotoxumab (56% vs 46%).
IN PRACTICE:
“As bezlotoxumab can be used to prevent recurrence in high-risk patients during their first episode of CDI, it may be more appropriate to use these therapies early and sequentially,” the study authors wrote.
SOURCE:
The study, with first author Jessica R. Allegretti, MD, MPH, from Brigham and Women’s Hospital, Boston, Massachusetts, was published online on March 19 in the American Journal of Gastroenterology.
LIMITATIONS:
The study was limited by the sample size and inclusion of PCR-only testing for the qualifying episode.
DISCLOSURES:
The trial was funded by an investigator-initiated grant from Merck Sharpe and Dohme. Several authors reported consultancy fees, research grants, and advisory board member roles with numerous pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and recurrent Clostridioides difficile infection (CDI), there›s no clear benefit to using both vs FMT alone.
METHODOLOGY:
- Researchers conducted a randomized placebo-controlled trial among 61 patients with IBD (20 with Crohn’s disease and 41 with ulcerative colitis) who had two or more episodes of CDI.
- All participants received a single colonoscopic FMT from a universal stool bank and were randomly assigned to receive a single bezlotoxumab infusion or placebo infusion before or at the time of the FMT.
- Patients were measured for CDI recurrence, defined as presence of diarrhea and positive glutamate dehydrogenase and enzyme immunoassay toxin test results, up to week 8 after treatment.
- Researchers also looked at C difficile decolonization, defined as absence of diarrhea and negative polymerase chain reaction (PCR) test results, and changes in IBD disease activity through week 12.
TAKEAWAY:
- Five participants (8%) had a CDI recurrence, including four who received bezlotoxumab and one who received placebo (13% vs 3%).
- Although participants in the treatment arm had higher odds of CDI recurrence, the difference wasn’t statistically significant.
- More patients who received bezlotoxumab were decolonized compared to placebo, both at week 1 (82% vs 68%) and week 12 (83% vs 72%), though the difference wasn’t statistically significant.
- There weren’t any significant differences in IBD outcomes, although there were higher rates of IBD improvement among those who received bezlotoxumab (56% vs 46%).
IN PRACTICE:
“As bezlotoxumab can be used to prevent recurrence in high-risk patients during their first episode of CDI, it may be more appropriate to use these therapies early and sequentially,” the study authors wrote.
SOURCE:
The study, with first author Jessica R. Allegretti, MD, MPH, from Brigham and Women’s Hospital, Boston, Massachusetts, was published online on March 19 in the American Journal of Gastroenterology.
LIMITATIONS:
The study was limited by the sample size and inclusion of PCR-only testing for the qualifying episode.
DISCLOSURES:
The trial was funded by an investigator-initiated grant from Merck Sharpe and Dohme. Several authors reported consultancy fees, research grants, and advisory board member roles with numerous pharmaceutical companies.
A version of this article appeared on Medscape.com.
TOPLINE:
Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and recurrent Clostridioides difficile infection (CDI), there›s no clear benefit to using both vs FMT alone.
METHODOLOGY:
- Researchers conducted a randomized placebo-controlled trial among 61 patients with IBD (20 with Crohn’s disease and 41 with ulcerative colitis) who had two or more episodes of CDI.
- All participants received a single colonoscopic FMT from a universal stool bank and were randomly assigned to receive a single bezlotoxumab infusion or placebo infusion before or at the time of the FMT.
- Patients were measured for CDI recurrence, defined as presence of diarrhea and positive glutamate dehydrogenase and enzyme immunoassay toxin test results, up to week 8 after treatment.
- Researchers also looked at C difficile decolonization, defined as absence of diarrhea and negative polymerase chain reaction (PCR) test results, and changes in IBD disease activity through week 12.
TAKEAWAY:
- Five participants (8%) had a CDI recurrence, including four who received bezlotoxumab and one who received placebo (13% vs 3%).
- Although participants in the treatment arm had higher odds of CDI recurrence, the difference wasn’t statistically significant.
- More patients who received bezlotoxumab were decolonized compared to placebo, both at week 1 (82% vs 68%) and week 12 (83% vs 72%), though the difference wasn’t statistically significant.
- There weren’t any significant differences in IBD outcomes, although there were higher rates of IBD improvement among those who received bezlotoxumab (56% vs 46%).
IN PRACTICE:
“As bezlotoxumab can be used to prevent recurrence in high-risk patients during their first episode of CDI, it may be more appropriate to use these therapies early and sequentially,” the study authors wrote.
SOURCE:
The study, with first author Jessica R. Allegretti, MD, MPH, from Brigham and Women’s Hospital, Boston, Massachusetts, was published online on March 19 in the American Journal of Gastroenterology.
LIMITATIONS:
The study was limited by the sample size and inclusion of PCR-only testing for the qualifying episode.
DISCLOSURES:
The trial was funded by an investigator-initiated grant from Merck Sharpe and Dohme. Several authors reported consultancy fees, research grants, and advisory board member roles with numerous pharmaceutical companies.
A version of this article appeared on Medscape.com.
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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and re</metaDescription> <articlePDF/> <teaserImage/> <teaser>There were higher rates of IBD improvement in those who received bezlotoxumab, but the difference was not significant.</teaser> <title>No Clear Benefit to Combination Treatment to Prevent Recurrent C. difficile in IBD</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>15</term> <term canonical="true">21</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">213</term> <term>234</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>No Clear Benefit to Combination Treatment to Prevent Recurrent C. difficile in IBD</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p>Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and recurrent <em>Clostridioides difficile</em> infection (CDI), there›s no clear benefit to using both vs FMT alone.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>Researchers conducted a randomized placebo-controlled trial among 61 patients with IBD (20 with Crohn’s disease and 41 with ulcerative colitis) who had two or more episodes of CDI.</li> <li>All participants received a single colonoscopic FMT from a universal stool bank and were randomly assigned to receive a single bezlotoxumab infusion or placebo infusion before or at the time of the FMT.</li> <li>Patients were measured for CDI recurrence, defined as presence of diarrhea and positive glutamate dehydrogenase and enzyme immunoassay toxin test results, up to week 8 after treatment.</li> <li>Researchers also looked at C difficile decolonization, defined as absence of diarrhea and negative polymerase chain reaction (PCR) test results, and changes in IBD disease activity through week 12.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>Five participants (8%) had a CDI recurrence, including four who received bezlotoxumab and one who received placebo (13% vs 3%).</li> <li>Although participants in the treatment arm had higher odds of CDI recurrence, the difference wasn’t statistically significant.</li> <li>More patients who received bezlotoxumab were decolonized compared to placebo, both at week 1 (82% vs 68%) and week 12 (83% vs 72%), though the difference wasn’t statistically significant.</li> <li>There weren’t any significant differences in IBD outcomes, although there were higher rates of IBD improvement among those who received bezlotoxumab (56% vs 46%).</li> </ul> <h2>IN PRACTICE:</h2> <p>“As bezlotoxumab can be used to prevent recurrence in high-risk patients during their first episode of CDI, it may be more appropriate to use these therapies early and sequentially,” the study authors wrote.</p> <h2>SOURCE:</h2> <p>The study, with first author Jessica R. Allegretti, MD, MPH, from Brigham and Women’s Hospital, Boston, Massachusetts, was <a href="https://journals.lww.com/ajg/abstract/9900/outcomes_after_fecal_microbiota_transplantation_in.1081.aspx">published online</a> on March 19 in the <em>American Journal of Gastroenterology</em>.</p> <h2>LIMITATIONS:</h2> <p>The study was limited by the sample size and inclusion of PCR-only testing for the qualifying episode.</p> <h2>DISCLOSURES:</h2> <p>The trial was funded by an investigator-initiated grant from Merck Sharpe and Dohme. Several authors reported consultancy fees, research grants, and advisory board member roles with numerous pharmaceutical companies.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/no-benefit-combo-tx-prevent-recurrent-c-diff-ibd-2024a10005ol">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>