4.7 Article

Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection

Journal

JOURNAL OF CLINICAL MEDICINE
Volume 10, Issue 1, Pages -

Publisher

MDPI
DOI: 10.3390/jcm10010002

Keywords

Clostridium difficile; Clostridioides difficile; C. difficile infection; bezlotoxumab; recurrence

Funding

  1. Plan Nacional de I+D+i 2013-2016
  2. Instituto de Salud Carlos III, Subdireccion General de Redes y Centros de Investigacion Cooperativa, Ministerio de Ciencia, Innovacion y Universidades, Spanish Network for Research in Infectious Diseases - European Development Regional Fund A way to achie [REIPI RD16/0016/0011]

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A study in Spain confirmed the effectiveness of bezlotoxumab in preventing rCDI, despite the patients being at higher risk than those in clinical trials. Bezlotoxumab showed no adverse effects in the study, and it was found to be effective even in a more compromised population.
Bezlotoxumab is marketed for the prevention of recurrent Clostridioides difficile infection (rCDI). Its high cost could be determining its prescription to a different population than that represented in clinical trials. The objective of the study was to verify the effectiveness and safety of bezlotoxumab in preventing rCDI and to investigate factors related to bezlotoxumab failure in the real world. A retrospective, multicentre cohort study of patients treated with bezlotoxumab in Spain was conducted. We compared the characteristics of cohort patients with those of patients treated with bezlotoxumab in the pivotal MODIFY trials. We assessed recurrence rates 12 weeks after completion of treatment against C. difficile, and we analysed the factors associated with bezlotoxumab failure. Ninety-one patients were included in the study. The cohort presented with more risk factors for rCDI than the patients included in the MODIFY trials. Thirteen (14.2%) developed rCDI at 12 weeks of follow-up, and rCDI rates were numerically higher in patients with two or more previous episodes (25%) than in those who had fewer than two previous episodes of C. difficile infection (CDI) (10.4%); p = 0.09. There were no adverse effects attributable to bezlotoxumab. Despite being used in a more compromised population than that represented in clinical trials, we confirm the effectiveness of bezlotoxumab for the prevention of rCDI.

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