Loading ...

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.