The Role of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infections: A Review of the Current Literature and Paradigm Shift after 2021

Abstract

Clostridioides difficile infections (CDIs), and particularly recurrent infections, cause a significant burden on the health-care system. Bezlotoxumab is a new agent for the prevention of recurrent CDIs that has shown strong efficacy and high tolerability in clinical trials. The purpose of this review is to evaluate the published literature for bezlotoxumab, with a focus on literature published since the release of the 2021 focused update to the CDI treatment guidelines. A Medline/PubMed search for “bezlotoxumab” was conducted, resulting in 152 articles. Seventeen studies are included in this review, after excluding non-English-language papers, phase I and II trials, and review articles. Studies published since the 2021 focused update support the recommendations in those guidelines. Furthermore, real-world studies have shown similar results to larger clinical trials. Those with more risk factors for recurrent CDI appear to benefit most from bezlotoxumab. Currently, there are no data to support the use of bezlotoxumab outside current guideline recommendations, but future trials may build on the data seen in real-world studies to further elucidate the place in therapy for bezlotoxumab.

Clostridioides difficile infection: a changing treatment paradigm

“…Fidaxomicin received approval from the US Food and Drug Administration (FDA) in 2011, marking a pivotal development in CDI treatment [ 10 ]. In the IDSA/SHEA guideline updates, a significant consideration is introduced regarding the recommendation of fidaxomicin over a standard course of vancomycin for initial CDI treatment – specifically, the choice of fidaxomicin hinges on resource availability [ 7 ].…”

“…In 2016, the FDA granted approval to bezlotoxumab, marking a milestone as the first monoclonal antibody introduced into the CDI treatment repertoire, specifically designed to prevent CDI recurrence [ 10 ]. Bezlotoxumab’s mechanism of action centres on targeting toxin B, a product of C. difficile [ 4 ].…”

<i>Clostridioides difficile</i> – a new name, the old problems with diagnosis and treatment

“…Пациенты с большим количеством факторов риска рецидивирующей КДИ, по-видимому, получают наибольшую пользу от безлотоксумаба. Авторы считают, что в настоящее время нет данных в поддержку использования безлотоксумаба за пределами текущих рекомендаций по лечению КДИ [68].…”

Efficacy, Safety, and Cost-effectiveness of Bezlotoxumab in Preventing Recurrent Clostridioides difficile Infection

“…It is administered as a single intravenous infusion at a dose of 10 mg/kg over a 60-minute period. 5 The MODIFY I and II trials were pivotal phase 3 clinical trials that evaluated the efficacy and safety of BEZ. These trials demonstrated a nearly 40% relative risk (RR) reduction in rCDI at 12 weeks when BEZ was added to standard-of-care (SOC) therapy.…”

“…Bezlotoxumab (BEZ) is an intravenous monoclonal antibody against C. difficile toxin B with an estimated half-life of 19 days. It is administered as a single intravenous infusion at a dose of 10 mg/kg over a 60-minute period 5 . The MODIFY I and II trials were pivotal phase 3 clinical trials that evaluated the efficacy and safety of BEZ.…”