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

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 bezloto...

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Autores principales: Escudero-Sánchez, Rosa, Ruiz-Ruigómez, María, Fernández-Fradejas, Jorge, García Fernández, Sergio, Olmedo Samperio, María, Cano Yuste, Angela, Valencia Alijo, Angela, Díaz-Pollán, Beatriz, Rodríguez Hernández, María Jesús, Merino De Lucas, Esperanza, Martín Segarra, Oriol, Sáez Bejar, Carmen, Armiñanzas Castillo, Carlos, Gutiérrez-Gutiérrez, Belén, Rodríguez-Pardo, Dolors, Ramos-Martínez, Antonio, Torre-Cisneros, Julián, López-Medrano, Francisco, Cobo Reinoso, Javier
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792623/
https://www.ncbi.nlm.nih.gov/pubmed/33374989
http://dx.doi.org/10.3390/jcm10010002
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author Escudero-Sánchez, Rosa
Ruiz-Ruigómez, María
Fernández-Fradejas, Jorge
García Fernández, Sergio
Olmedo Samperio, María
Cano Yuste, Angela
Valencia Alijo, Angela
Díaz-Pollán, Beatriz
Rodríguez Hernández, María Jesús
Merino De Lucas, Esperanza
Martín Segarra, Oriol
Sáez Bejar, Carmen
Armiñanzas Castillo, Carlos
Gutiérrez-Gutiérrez, Belén
Rodríguez-Pardo, Dolors
Ramos-Martínez, Antonio
Torre-Cisneros, Julián
López-Medrano, Francisco
Cobo Reinoso, Javier
author_facet Escudero-Sánchez, Rosa
Ruiz-Ruigómez, María
Fernández-Fradejas, Jorge
García Fernández, Sergio
Olmedo Samperio, María
Cano Yuste, Angela
Valencia Alijo, Angela
Díaz-Pollán, Beatriz
Rodríguez Hernández, María Jesús
Merino De Lucas, Esperanza
Martín Segarra, Oriol
Sáez Bejar, Carmen
Armiñanzas Castillo, Carlos
Gutiérrez-Gutiérrez, Belén
Rodríguez-Pardo, Dolors
Ramos-Martínez, Antonio
Torre-Cisneros, Julián
López-Medrano, Francisco
Cobo Reinoso, Javier
author_sort Escudero-Sánchez, Rosa
collection PubMed
description 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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spelling pubmed-77926232021-01-09 Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection Escudero-Sánchez, Rosa Ruiz-Ruigómez, María Fernández-Fradejas, Jorge García Fernández, Sergio Olmedo Samperio, María Cano Yuste, Angela Valencia Alijo, Angela Díaz-Pollán, Beatriz Rodríguez Hernández, María Jesús Merino De Lucas, Esperanza Martín Segarra, Oriol Sáez Bejar, Carmen Armiñanzas Castillo, Carlos Gutiérrez-Gutiérrez, Belén Rodríguez-Pardo, Dolors Ramos-Martínez, Antonio Torre-Cisneros, Julián López-Medrano, Francisco Cobo Reinoso, Javier J Clin Med Article 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. MDPI 2020-12-22 /pmc/articles/PMC7792623/ /pubmed/33374989 http://dx.doi.org/10.3390/jcm10010002 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Escudero-Sánchez, Rosa
Ruiz-Ruigómez, María
Fernández-Fradejas, Jorge
García Fernández, Sergio
Olmedo Samperio, María
Cano Yuste, Angela
Valencia Alijo, Angela
Díaz-Pollán, Beatriz
Rodríguez Hernández, María Jesús
Merino De Lucas, Esperanza
Martín Segarra, Oriol
Sáez Bejar, Carmen
Armiñanzas Castillo, Carlos
Gutiérrez-Gutiérrez, Belén
Rodríguez-Pardo, Dolors
Ramos-Martínez, Antonio
Torre-Cisneros, Julián
López-Medrano, Francisco
Cobo Reinoso, Javier
Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection
title Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection
title_full Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection
title_fullStr Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection
title_full_unstemmed Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection
title_short Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection
title_sort real-world experience with bezlotoxumab for prevention of recurrence of clostridioides difficile infection
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792623/
https://www.ncbi.nlm.nih.gov/pubmed/33374989
http://dx.doi.org/10.3390/jcm10010002
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