4CPS-072 Bezlotoxumab for the prevention of<i>Clostridioides difficile</i>recurrence: study in the real world

Herrero, S. A. Santamaría; Rodriguez, C; Chamorro, E; Valerio, M; Olmedo, M; Herranz, A; Sanjurjo, M

doi:10.1136/ejhpharm-2022-eahp.109

Cited by 2 publications

(4 citation statements)

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“…1). Relevant articles were not included based on the inclusion of a recently published more representative cohort from the same sample 22–29 . Two studies were randomized trials (MODIFY I and II) 6 and the remaining were observational 11–16,30–34 .…”

Section: Resultsmentioning

confidence: 99%

“…Relevant articles were not included based on the inclusion of a recently published more representative cohort from the same sample. [22][23][24][25][26][27][28][29] Two studies were randomized trials (MODIFY I and II) 6 and the remaining were observational. [11][12][13][14][15][16][30][31][32][33][34] Overall, 1472 patients received BEZ (691 excluding RCTs).…”

Section: Included Studies and Baseline Characteristicsmentioning

confidence: 99%

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

Mohamed

Ward

Beran

et al. 2023

Journal of Clinical Gastroenterology

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Introduction: Clostridioides difficile infection (CDI) remains a global health challenge. Bezlotoxumab (BEZ) is a monoclonal antibody against C. difficile toxin B. Two randomized controlled trials (RCTs), MODIFY I and II, confirmed BEZ efficacy in preventing recurrent Clostridioides difficile infection (rCDI). However, there are safety concerns about its use in patients with a history of congestive heart failure. Observational studies have since been conducted, and it is important to explore the consistency of BEZ efficacy, cost-effectiveness, and its safety utilizing these real-world data. Methods: We performed a systematic review and meta-analysis to pool the rate of rCDI in patients receiving BEZ and explore its efficacy and safety in preventing rCDI compared with control. We searched PubMed, EMBASE, Cochrane Library, and Google Scholar from inception through April 2023 for relevant RCTs or observational studies assessing BEZ in preventing rCDI. Single-arm studies describing experience with BEZ in preventing rCDI were also included for proportion meta-analysis. A proportion meta-analysis with a random-effects model was used to pool the rCDI rate with its corresponding 95% CI. In a meta-analysis of efficacy, we generated the relative risk (RR) to compare BEZ versus control in preventing rCDI. Results: Thirteen studies including 2 RCTs and 11 observational studies totaling 2337 patients, of which 1472 received BEZ, were included in the analysis. Of the constituent studies, 5 (1734 patients) compared BEZ versus standard-of-care (SOC). Pooled rate of rCDI in patients receiving BEZ was 15.8% (95% CI: 14%-17.8%), and was 28.9% (95% CI: 24%-34.4%) in the SOC. BEZ significantly reduced rCDI risk compared with SOC [RR=0.57 (95% CI: 0.45-0.72, I 2=16%)]. There was no difference in the overall mortality or heart failure risk. Of the 9 included cost-effectiveness analyses, 8 demonstrated BEZ+SOC cost-effectiveness compared with SOC alone. Discussion: Our meta-analysis comprising real-world data revealed lower rCDI in patients receiving BEZ and supported its efficacy and safety when added to SOC therapy. The results were consistent across various subgroups. Available cost-effectiveness analyses mostly support BEZ+SOC cost-effectiveness compared with SOC alone.

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Section: Resultsmentioning

confidence: 99%

Section: Included Studies and Baseline Characteristicsmentioning

confidence: 99%

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

Mohamed

Ward

Beran

et al. 2023

Journal of Clinical Gastroenterology

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“…(15) If they performed quantitative synthesis did the review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on the results of the review? (16)…”

Section: Qualitymentioning

confidence: 99%

“…Within 12 weeks of receiving bezlotoxumab, there were nine (18.4%) recurrences. As nine patients died during the study, they were not included in the study and recurrence ratio is reported as 20.9% [16].…”

Section: Role Of Bezlotoxumab In the Prevention Of Recurrent C Difficilementioning

confidence: 99%

The Efficacy of Bezlotoxumab in the Prevention of Recurrent Clostridium difficile: A Systematic Review

Thandavaram¹,

Channar²,

Purohit³

et al. 2022

Cureus

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Clostridium difficile infection (CDI) is the most common nosocomial infection in hospitals. Despite the fact that CDI has treatment options, recurrence is common after the treatment, recurrence will occur in approximately 20%-35% of people initially affected, with 40%-60% of these having a second recurrence. Patients are more likely to have several recurrences after the second, which can lead to antibiotic overuse, and as a result, CDI-related health care expenses, hospitalizations, and mortality are on the rise. The first treatment to receive Food and Drug Administration (FDA) approval for the prevention of C. difficile recurrence is bezlotoxumab, a novel human monoclonal antibody against C. difficile toxin B. In the present systematic review, we assessed various studies from PubMed, PubMed Central (PMC), Google Scholar, and Science direct that evaluated the efficacy of bezlotoxumab in the prevention of recurrent C. difficile (rCDI), and we also briefly discussed the pathophysiology of C. difficile and the risk factors for recurrence of C. difficile. The major MODIFY trial has proven the efficacy, pooled analysis of MODIFY 1 AND 2 trials demonstrated the following results as compared to placebo (bezlotoxumab

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4CPS-072 Bezlotoxumab for the prevention ofClostridioides difficilerecurrence: study in the real world

Cited by 2 publications

References 0 publications

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

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

The Efficacy of Bezlotoxumab in the Prevention of Recurrent Clostridium difficile: A Systematic Review

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