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: Escudero-Sánchez, Rosa, Ruiz-Ruigómez, María, Fernández-Fradejas, Jorge, García Fernández, Sergio, Olmedo Samperio, María, Cano Yuste, Ángela, Valencia Alijo, Ángela, Díaz-Pollán, Beatriz, Rodríguez Hernández, María Jesús, Merino De Lucas, Esperanza, Martín Segarra, Oriol, Sáez Bejar, Carmen María, Armiñanzas Castillo, Carlos, Gutiérrez-Gutiérrez, Belén, Rodríguez-Pardo, Dolors, Ramos Martínez, Antonio, Torre-Cisneros, Julián, López Medrano, Francisco, Cobo Reinoso, Javier
Tipo de recurso: artículo
Fecha de publicación:2020
País:España
Institución:Universidad Autónoma de Madrid
Repositorio:Biblos-e Archivo. Repositorio Institucional de la UAM
Idioma:inglés
OAI Identifier:oai:repositorio.uam.es:10486/698167
Acceso en línea:http://hdl.handle.net/10486/698167
https://dx.doi.org/10.3390/jcm10010002
Access Level:acceso abierto
Palabra clave:Clostridium difficile
Clostridioides difficile
C. difficile infection
bezlotoxumab
recurrence
Medicina
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spelling Real-world experience with bezlotoxumab for prevention of recurrence of Clostridioides difficile infectionEscudero-Sánchez, RosaRuiz-Ruigómez, MaríaFernández-Fradejas, JorgeGarcía Fernández, SergioOlmedo Samperio, MaríaCano Yuste, ÁngelaValencia Alijo, ÁngelaDíaz-Pollán, BeatrizRodríguez Hernández, María JesúsMerino De Lucas, EsperanzaMartín Segarra, OriolSáez Bejar, Carmen MaríaArmiñanzas Castillo, CarlosGutiérrez-Gutiérrez, BelénRodríguez-Pardo, DolorsRamos Martínez, AntonioTorre-Cisneros, JuliánLópez Medrano, FranciscoCobo Reinoso, JavierClostridium difficileClostridioides difficileC. difficile infectionbezlotoxumabrecurrenceMedicinaBezlotoxumab 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, Basel, SwitzerlandDepartamento de MedicinaFacultad de Medicina20202020-12-22research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/698167https://dx.doi.org/10.3390/jcm10010002reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/6981672026-06-23T12:46:27Z
dc.title.none.fl_str_mv 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
spellingShingle Real-world experience with bezlotoxumab for prevention of recurrence of Clostridioides difficile infection
Escudero-Sánchez, Rosa
Clostridium difficile
Clostridioides difficile
C. difficile infection
bezlotoxumab
recurrence
Medicina
title_short 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_sort Real-world experience with bezlotoxumab for prevention of recurrence of Clostridioides difficile infection
dc.creator.none.fl_str_mv Escudero-Sánchez, Rosa
Ruiz-Ruigómez, María
Fernández-Fradejas, Jorge
García Fernández, Sergio
Olmedo Samperio, María
Cano Yuste, Ángela
Valencia Alijo, Ángela
Díaz-Pollán, Beatriz
Rodríguez Hernández, María Jesús
Merino De Lucas, Esperanza
Martín Segarra, Oriol
Sáez Bejar, Carmen María
Armiñanzas Castillo, Carlos
Gutiérrez-Gutiérrez, Belén
Rodríguez-Pardo, Dolors
Ramos Martínez, Antonio
Torre-Cisneros, Julián
López Medrano, Francisco
Cobo Reinoso, Javier
author Escudero-Sánchez, Rosa
author_facet Escudero-Sánchez, Rosa
Ruiz-Ruigómez, María
Fernández-Fradejas, Jorge
García Fernández, Sergio
Olmedo Samperio, María
Cano Yuste, Ángela
Valencia Alijo, Ángela
Díaz-Pollán, Beatriz
Rodríguez Hernández, María Jesús
Merino De Lucas, Esperanza
Martín Segarra, Oriol
Sáez Bejar, Carmen María
Armiñanzas Castillo, Carlos
Gutiérrez-Gutiérrez, Belén
Rodríguez-Pardo, Dolors
Ramos Martínez, Antonio
Torre-Cisneros, Julián
López Medrano, Francisco
Cobo Reinoso, Javier
author_role author
author2 Ruiz-Ruigómez, María
Fernández-Fradejas, Jorge
García Fernández, Sergio
Olmedo Samperio, María
Cano Yuste, Ángela
Valencia Alijo, Ángela
Díaz-Pollán, Beatriz
Rodríguez Hernández, María Jesús
Merino De Lucas, Esperanza
Martín Segarra, Oriol
Sáez Bejar, Carmen María
Armiñanzas Castillo, Carlos
Gutiérrez-Gutiérrez, Belén
Rodríguez-Pardo, Dolors
Ramos Martínez, Antonio
Torre-Cisneros, Julián
López Medrano, Francisco
Cobo Reinoso, Javier
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Departamento de Medicina
Facultad de Medicina
dc.subject.none.fl_str_mv Clostridium difficile
Clostridioides difficile
C. difficile infection
bezlotoxumab
recurrence
Medicina
topic Clostridium difficile
Clostridioides difficile
C. difficile infection
bezlotoxumab
recurrence
Medicina
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.
publishDate 2020
dc.date.none.fl_str_mv 2020
2020-12-22
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10486/698167
https://dx.doi.org/10.3390/jcm10010002
url http://hdl.handle.net/10486/698167
https://dx.doi.org/10.3390/jcm10010002
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI, Basel, Switzerland
publisher.none.fl_str_mv MDPI, Basel, Switzerland
dc.source.none.fl_str_mv reponame:Biblos-e Archivo. Repositorio Institucional de la UAM
instname:Universidad Autónoma de Madrid
instname_str Universidad Autónoma de Madrid
reponame_str Biblos-e Archivo. Repositorio Institucional de la UAM
collection Biblos-e Archivo. Repositorio Institucional de la UAM
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300724

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