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Bezlotoxumab is a fully humanized monoclonal antibody approved by the US Food and Drug Administration in 2017 for the prevention of recurrent CDI.
New data continues to show bezlotoxumab can be a safe and effective choice in preventing recurrence after initial Clostridium difficile infections (CDI) episodes.
A team, led by Abdelkader Chaar, MD, Yale University School of Medicine, reported real-world data on bezlotoxumab use at a large healthcare system for patients with recurrent CDI.
The data was presented during the 2022 American College of Gastroenterology (ACG) Annual Meeting in Charlotte.
CDI is currently the most common healthcare-associated infection in the US. Treatment guidelines have changed to produce better outcomes. However, a major hurdle preventing better care is disease recurrence, which is linked to significant morbidity.
One drug that has shown promise is bezlotoxumab, a fully humanized monoclonal antibody approved by the US Food and Drug Administration in 2017 for the prevention of recurrent CDI.
However, there remains a need for real-word data on bezlotoxumab usage.
In the multicenter study, the investigators reviewed 114 consecutive adult patients who were treated with bezlotoxumab from 2017-2021 at the Yale-New Haven Health System, with at least 90 daysof follow-up.
The patient population had a mean age of 67.3 years and 64.9% (n = 74) of the patients were female.
The team collected data for each patient including demographics, medical co-morbidities, adverse events related to the treatment, and the rates of recurrent CDI following bezlotoxumab treatment.
The results show the ongoing COVID-19 pandemic has had an impact on bezlotoxumab use.
Since the pandemic began, 64% (n = 73) of the patient population was treated with bezlotoxumab, with 38.6% occurring in 2021 alone.
However, the majority of patients were still treated with vancomycin (88.6%) and 9.7% (n = 11) received fidaxomicin.
The median time from the most recent CDI episode to bezlotoxumab infusion was 22.5 days and 17.5% were not on active CDI treatment when they were treated with bezlotoxumab.
In addition, 26.3% (n = 30) received bezlotoxumab following an initial CDI episode, 45.6% (n = 52) had 1 prior recurrent episode, and 28.1% (n = 32) had 2 or more previous recurrences.
Of the patients treated with bezlotoxumab, 8.8% (n = 10) experienced 90-day rCDI. Of this group, 90% (n = 9) had history of at least 1 episode of rCDI.
The baseline characteristics were similar between the rCDI and non-rCDI groups.
There was also no statistical difference in rCDI between patients on CDI treatment at the time of bezlotoxumab (9.6%; n = 9) and patients who completed CDI treatment prior to bezlotoxumab (5%; n = 1) (P = 0.511).
“Our real-life data confirms that Bezlotoxumab appears to be safe and effective in preventing rCDI in this population whether given during CDI treatment or after,” the authors wrote. “Bezlotoxumab represents an important treatment option in this highly morbid population. Further studies are needed to determine the benefit of early administration of bezlotoxumab after index CDI in those at risk and to consider utilization shifts following the 2021 ACG updated guideline recommendations advising it’s usage.”
The study, “A0084 - Outcomes of Patients Receiving Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection – A Multicenter Study,” was published online by ACG.