Background: Bezlotoxumab (BEZ) was approved in October 2016 for the prevention of recurrent C. difficile (rCDI) infection in patients (pts) receiving standard-of-care (SoC) antibiotic therapy for active CDI who are at high risk for CDI recurrence. Presently, there are little real-world data on recurrence rates and factors associated with recurrence in pts receiving BEZ. This study describes characteristics of pts receiving BEZ in US outpatient infusion centers (OICs) and analyzes subsequent CDI recurrences.
Methods: Medical records from 24 OICs were retrospectively reviewed of all pts treated with BEZ through December 2017. Data collected included demographics, comorbidities, and all therapy parameters, including SoC antibiotic therapy. Risk factors for rCDI were assessed and included age, immunocompromised status, prior number of CDI episodes, use of gastric acid suppressants, inflammatory bowel disease (IBD) and history of fecal microbiota transplant (FMT). rCDI, defined as diarrhea lasting ≥2 days with treatment for CDI with or without a positive stool test for toxigenic C. difficile, was assessed through a follow-up visit or phone call 90 days post BEZ administration. Risk factors for rCDI were evaluated using Students t test and Pearson Chi square test.
Results: Eighty pts received BEZ (10 mg/kg) with 78 available for follow-up evaluation for rCDI ≥90 days post treatment. Mean age was 65±16 years with 51% female. Mean number of CDI episodes were 3±1 with a mean Charlson score of 4±3. SoC antibiotics included vancomycin (66% of pts) with 41% on long term taper, fidaxomicin (33% of pts), and metronidazole (25% of pts). Nineteen (24%) patients received more than one SoC antibiotic during their treatment course, most commonly with metronidazole and another SoC antibiotic. Of the 78 pts with follow-up data, 17 (22%) developed rCDI with a mean time to recurrence of 33±22 days. Risk factors for rCDI are shown in the table. Use of BEZ earlier in the disease course (1st or 2nd CDI episode) was associated with a decreased risk of rCDI (OR: 0.21 95% CI: 0.04-0.98; p=0.033).
Conclusion: In highly comorbid patients with recurrent Clostridium difficile infection, bezlotoxumab use was effective in prevention of recurrence at 90 days and consistent with that of the randomized trials.
R. L. Hengel,
Merck & Co.:
R. V. Nathan, Merck & Co.: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium . The Medicines Company: Speaker's Bureau , Speaker honorarium . Allergan: Speaker's Bureau , Speaker honorarium .
L. J. Van Anglen, Merck & Co.: Grant Investigator , Research grant .
C. P. Schroeder, None
S. Marcella, Merck & Co.: Employee and Shareholder , Salary .
K. W. Garey, Merck & Co.: Grant Investigator , Grant recipient .