‘No clear efficacy benefit’ to combining bezlotoxumab with FMT in IBD, recurrent C. diff
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Key takeaways:
- More patients in the bezlotoxumab group experienced recurrence vs. the placebo group (13% vs. 3%).
- Steroid use at the time of FMT significantly increased risk for ongoing colonization at 12 weeks after FMT.
PHILADELPHIA — Bezlotoxumab in combination with fecal microbiota transplantation did not further reduce recurrence of Clostridioides difficile infection in patients with inflammatory bowel disease, according to data presented here.
“This was the first clinical trial to assess the clinical effect of FMT in combination with bezlotoxumab in patients with IBD and recurrent C. diff,” Jessica R. Allegretti, MD, MPH, FACG, medical director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital in Boston and associate professor of medicine at Harvard Medical School, said at the ACG Annual Scientific Meeting. “This data suggests no clear efficacy benefit to the combination approach compared to FMT alone.”
To investigate the effect of FMT in combination with bezlotoxumab — a human monoclonal antibody that binds to C. difficile toxin B — in patients with IBD and recurrent C. diff infection, Allegretti and colleagues conducted a multicenter trial of 61 patients (median age, 38 years; 54% men; Crohn’s disease, n = 20; ulcerative colitis, n = 41) with at least two episodes of C. diff infection. The median baseline fecal calprotectin was 635.
The researchers randomly assigned patients to a single infusion of bezlotoxumab (n = 30) or placebo (n = 31) prior to FMT and performed C. diff testing, which included glutamate dehydrogenase/enzyme immunoassay (EIA) toxin and polymerase chain reaction, before FMT and at weeks 1, 8 and 12 after the procedure. Fecal calprotectin and IBD clinical scores were also assessed at each visit.
The primary outcome was FMT efficacy, or lack of C. diff recurrence up to week 8, defined as diarrhea and a positive EIA toxin test. Secondary outcomes included post-treatment decolonization through week 12 and IBD improvement or worsening.
According to results, 8% of patients experienced C. diff recurrence, which included 13% in the treatment group and 3% in the placebo group (OR = 4.6; 95% CI, 0.5-43.9). In addition, more bezlotoxumab-treated patients were decolonized at weeks 1 (82% vs. 68%) and 12 (83% vs. 72%).
Allegretti also noted that steroid use at the time of FMT resulted in “significantly increased risk” for ongoing colonization of C. diff 12 weeks after transplantation (OR = 4.9; 95% CI, 1.18-20.37) — a “critical factor for future risk of recurrence.”
Although there were no statistically significant differences reported in IBD outcomes between groups, one patient in the placebo arm experienced IBD worsening. The treatments were safe and well-tolerated.
“Given the high efficacy of FMT, the addition of bezlotoxumab may not provide a further reduction in C. diff recurrence,” Allegretti said. “Notably, there were numerically higher rates of C. diff decolonization in the treatment arm.”
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Allegretti J, et al. Fecal microbiota transplantation with bezlotoxumab was not better than FMT alone in inflammatory bowel disease patients and recurrent Clostridioides difficile infection results from a randomized controlled trial. Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).
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