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

Rosa Escudero-Sánchez1,2, María Ruíz-Ruizgómez3, Jorge Fernández-Fradejas4

  • 1Infectious disease Department, University Hospital Ramón y Cajal, 28034 Madrid, Spain.

Journal of Clinical Medicine
|December 30, 2020
PubMed

Insights

Bezlotoxumab effectively prevents recurrent Clostridioides difficile infection (rCDI) in real-world patients, even those with more risk factors than seen in trials. This confirms its safety and utility beyond clinical study populations.

Area of Science:

  • Infectious Diseases
  • Pharmacology
  • Clinical Medicine

Background:

  • Bezlotoxumab is approved for preventing recurrent Clostridioides difficile infection (rCDI).
  • High cost may influence its use in patient populations different from clinical trials.
  • Real-world data is needed to confirm effectiveness and safety in broader patient groups.

Purpose of the Study:

  • To evaluate bezlotoxumab's effectiveness and safety in preventing rCDI in a real-world setting.
  • To identify factors associated with bezlotoxumab failure in clinical practice.
  • To compare the characteristics of real-world patients with those in pivotal trials.

Main Methods:

  • Retrospective, multicentre cohort study in Spain.
  • Inclusion of 91 patients treated with bezlotoxumab.
  • Assessment of rCDI recurrence at 12 weeks and analysis of failure factors.

Main Results:

  • 14.2% of patients developed rCDI within 12 weeks.
  • Higher recurrence rates observed in patients with two or more prior CDI episodes (25%) versus fewer (10.4%).
  • No adverse effects were attributed to bezlotoxumab.

Conclusions:

  • Bezlotoxumab is effective in preventing rCDI in a real-world population, including those with higher risk profiles.
  • The drug demonstrates a favorable safety profile.
  • Findings support bezlotoxumab's utility in a broader patient demographic than initially studied.

Keywords:
C. difficile infectionClostridioides difficileClostridium difficilebezlotoxumabrecurrence

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