Bezlotoxumab use can prevent recurrent Clostridioides difficile
) infection in the real world, according to a paper published
in Open Forum Infectious Diseases
Investigators from all over the United States retrospectively studied 200 patients across 34 centers in order to assess recurrent C diff
infection after 90-days post treatment with bezlotoxumab. The patients were treated with bezlotoxumab between April 2017 and December 2018. The antibody bezlotoxumab was approved for the prevention of recurrent C diff
in adult patients receiving standard care antibiotic therapy and who are at high risk for recurrence. Previous studies showed bezlotoxumab had significantly lower rates of recurrent C diff
and was especially effective in patients with more than 1 risk factor for recurrent C diff
, the study authors wrote.
The adult patients had a median age of 70 years and two-thirds of the cohort was female. A majority of the patients had prior C diff
episodes (86%). Most of the patients had 2 or more risk factors for recurrent C diff
(79%), including age greater than 65 years, history of C diff
in the previous 6 months, compromised immunity, severe C diff
infection, and having a strain associated with poor C diff
Prior to bezlotoxumab treatment, the standard of care antibiotics administered to the patients included fixed dose vancomycin (38%), tapered vancomycin (30%), fidaxomicin (30%), and metronidazole (1.5%). These were done in combination with bezlotoxumab, which was administered to those patients as a single intravenous infusion over 60 minutes, the investigators said.
Within 90 days, 31 patients (16%) experienced recurrent C diff
, the study authors found. They extrapolated this data to correspond to a success rate of 84%.
After treatment with bezlotoxumab, 17 of those patients were treated with standard antibiotics, 12 were treated with standard antibiotics plus fecal microbiota transplant (FMT), and 2 were treated with FMT only. Hospitalization due to recurrent C diff
was observed in 11 of those 31 patients and 3 were admitted with severe disease.
The median time to C diff
recurrence was 31 days, but ranged from 5 to 76 days. Half of the patients saw recurrent C diff
within 30 days, 14 patients between 30-60 days, and 2 between 60-90 days post- bezlotoxumab.
The study authors also found that patients with 2 or more C diff
recurrences before treatment with bezlotoxumab were independently associated with a higher risk for subsequent C diff
recurrence compared to those with just 1 recurrence or primary C diff
There were no infusion-related reactions for bezlotoxumab treatment, the study authors found. There were 2 deaths reported; 1 died a week post-bezlotoxumab but had a history of worsening interstitial lung disease, and another died 40 days post-bezlotoxumab but had systemic lupus, end stage renal disease, and 6 prior C diff
“Bezlotoxumab has been shown to effectively reduce the risk of recurrent C diff
infection in the pivotal MODIFY trials,” the study authors concluded. “Our findings indicate that a single infusion of bezlotoxumab resulted in a CDI recurrence rate of 15.9%, which is comparable to 16.5% reported for the overall population enrolled in the MODIFY trials.”
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