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Bezlotoxumab in Patients with a Primary Clostridioides difficile Infection: A Literature Review
Guido Granata1, Francesco Schiavone2, Giuseppe Pipitone3
1Clinical and Research Department for Infectious Diseases, National Institute for Infectious Diseases L. Spallanzani, IRCCS, 00149 Rome, Italy.
Insights
Bezlotoxumab effectively prevents recurrent Clostridioides difficile infection (CDI) when given with antibiotics. This monoclonal antibody reduces recurrence rates in patients experiencing their first CDI episode, offering a new management strategy.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Medicine
Background:
- Recurrent Clostridioides difficile infection (rCDI) presents a significant challenge in patient management, leading to increased mortality and healthcare expenses.
- High recurrence rates necessitate novel therapeutic strategies to improve patient outcomes and reduce the economic burden of CDI.
Purpose of the Study:
- To evaluate the efficacy and safety of bezlotoxumab in preventing rCDI following a primary CDI episode.
- To synthesize current evidence on bezlotoxumab's role in mitigating CDI recurrence.
Main Methods:
- A comprehensive literature search was conducted using PubMed with terms including "bezlotoxumab" and "Clostridioides difficile infection" (CDI).
- Searches covered articles published up to August 31, 2022, with a focus on studies involving bezlotoxumab for primary CDI prevention.
- References from retrieved articles were also reviewed to identify additional relevant studies.
Main Results:
- Five studies, including a Phase III trial and its sub-analyses, met the inclusion criteria.
- In the Phase III trial, bezlotoxumab reduced rCDI rates from 20.9% in the placebo group to 13.5% at 12 weeks (absolute difference: -7.4%).
Conclusions:
- Bezlotoxumab is a safe and effective adjunct to standard antibiotic therapy for reducing rCDI.
- Consideration of bezlotoxumab for patients with a primary CDI episode is supported by current evidence, despite its cost.
- Further research is warranted to identify specific patient subgroups and risk factors that may benefit most from bezlotoxumab treatment.
Background:
Nowadays, one of the main issues in the management of Clostridioides difficile infection (CDI) is the high rate of recurrences (rCDI), causing increased mortality and higher health care costs.
Objectives:
To assess the available evidence on the use of bezlotoxumab for the prevention of rCDI during a first CDI episode.
Methods:
Published articles on bezlotoxumab during a primary CDI episode were identified through computerized literature searches with the search terms [(bezlotoxumab) AND (CDI) OR (Clostridioides difficile infection)] using PubMed and by reviewing the references of retrieved articles. PubMed was searched until 31 August 2022.
Results:
Eighty-eight studies were identified as published from December 2014 to June 2022. Five studies were included in this study, one was a phase III clinical trial and four were sub-analyses or extensions of the previous phase III clinical trial. In the phase III clinical trial, the subgroup analysis on the included primary CDI patients showed that 13.5% of patients receiving bezlotoxumab had an rCDI, whilst 20.9% of patients in the placebo group had an rCDI at the twelve weeks follow-up (absolute difference: -7.4).
Conclusions:
Bezlotoxumab administration during the standard of care antibiotic therapy is effective and safe in reducing the rate of rCDI. Despite its high cost, evidence suggests considering bezlotoxumab in patients with a primary CDI episode. Further studies are needed to assess the benefit in specific subgroups of primary CDI patients and to define the risk factors to guide bezlotoxumab use.
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