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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Detalles Bibliográficos
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
Descripción
Sumario: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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