Real-world Experience of Bezlotoxumab for Prevention of Clostridioides difficile Infection: A Retrospective Multicenter Cohort Study.
Open Forum Infect Dis
; 7(4): ofaa097, 2020 Apr.
Article
em En
| MEDLINE
| ID: mdl-32363211
ABSTRACT
BACKGROUND:
Bezlotoxumab is approved for prevention of recurrence of Clostridioides difficile infection (CDI) in adults receiving standard of care (SoC) therapy based on findings from MODIFY clinical trials. However, utilization practices and validation of trial results in the real world are limited.METHODS:
Records of patients receiving bezlotoxumab between April 2017 and December 2018 across 34 infusion centers in the United States were retrospectively reviewed. Recurrent CDI (rCDI), defined as diarrhea lastingâ ≥2 days resulting in treatment, was assessed 90 days postbezlotoxumab.RESULTS:
The study cohort included 200 patients (median age, 70 years; 66% female; median Charlson comorbidity index, 5), of whom 86% (nâ =â 173) had prior CDI episodes and 79% (nâ =â 158) hadâ ≥2 risk factors for rCDI. SoC antibiotics included vancomycin (nâ =â 137, 68%), fidaxomicin (nâ =â 60, 30%), and metronidazole (nâ =â 3, 2%). Median time from C. difficile stool test to bezlotoxumab and initiation of SoC to bezlotoxumab were 15 days and 11 days, respectively. Within 90 days, 31 of 195 patients (15.9%) experienced rCDI, which corresponds to a success rate of 84.1%. Patients withâ ≥2 CDI recurrences prebezlotoxumab had a higher risk of subsequent rCDI compared with those with 1 recurrence or primary CDI (hazard ratio, 2.77; 95% confidence interval, 1.14-6.76; Pâ =â .025).CONCLUSIONS:
This real-world multicenter study demonstrated successful prevention of rCDI with bezlotoxumab comparable to clinical trial results regardless of type of SoC and timing of infusion. Multiple prior CDI recurrences were associated with a higher risk of subsequent rCDI, supporting the use of bezlotoxumab earlier in the disease course.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Open Forum Infect Dis
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Geórgia