Bezlotoxumab Reduces Odds of Recurrent C Difficile for Organ Transplant Recipients

June 10, 2021
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

Patients included in the study had a median of 3 prior CDI episodes and 4 risk factors for recurrent infections.

New research shows bezlotoxumab is effective at reducing the risk of recurrent Clostridioides difficile infections (CDI) at the 90 day mark in a cohort of patients recently receiving solid-organ transplantation.

A team, led by Tanner M. Johnson, Department of Pharmacy, UCHealth University of Colorado Hospital, compared recurrent C difficile infection rates in solid-organ and hematopoietic-cell transplant recipients.

Limited Data on This Relationship

There is limited data showing bezlotoxumab reduces the incidence of recurrent CDI in solid-organ and hematopoietic-cell transplant recipients.

In the single-center retrospective analysis, the researchers examined 94 patients receiving either standard of care alone (n = 56), comprised of oral vancomycin, fidaxomicin, or metronidazole or bezlotoxumab with standard of care (n = 38).

The mean age of the patient population was 53 years old. The patients also had a median of 3 prior C difficile episodes and 4 risk factors for recurrent infections.

The investigators sought primary outcomes of the 90-day incidence of recurrent CDI, as well as secondary outcomes of 90-day hospital readmission, mortality, and incidence of heart failure exacerbation.

The majority of patients were solid-organ transplant recipients (76%) and the median time to index infection occurred 2.7 years following transplantation.

Results

Overall, 90-day recurrent CDI occurred in 6 patients (16%) in the bezlotoxumab arm of the study. This occurred in 16 participants (29%) in the standard of care cohort (P = 0.13).

After the investigators used a multivariable regression, they found bezlotoxumab was linked to significantly lower odds of 90-day recurrent CDI (OR, 0.28; 95% CI, 0.08-0.91).

There were no differences in secondary outcomes, with no heart failure exacerbations observed.

“In a cohort of primarily solid-organ transplant recipients, bezlotoxumab was well tolerated and associated with lower odds of recurrent Clostridioides difficile infection at 90-days,” the authors wrote. “Larger, prospective trials are needed to confirm these findings amongst solid-organ and hematopoietic-cell transplant populations.”

Bezlotoxumab

In recent years, investigators found bezlotoxumab is effective in preventing C difficile infections recurrence as long as it is administered any time before suspending antibacterial drug treatment.

In 2018, researchers from New Jersey conducted a study of 1554 patients with C difficile infection in order to understand if the timing of bezlotoxumab administration affected clinical outcome with respect to the onset of C difficile.

Between November 2011 and May 2015, there were 781 patients who received bezlotoxumab while 773 patients received a placebo. Of those patients, 649 of them received a transfusion between 0 and 2 days after onset of antibacterial treatment for their C difficile infection; 469 patients received their transfusion between 3 and 4 days after onset; and 436 patients received their transfusion after 5 or more days.

The researchers also reported that baseline characteristics among the bezlotoxumab and placebo groups were generally similar.

The study, “Effectiveness of bezlotoxumab for prevention of recurrent Clostridioides difficile infection among transplant recipients,” was published online in Open Forum Infectious Diseases.


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