Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection.
Por:
Escudero-Sánchez R, Ruíz-Ruizgómez M, Fernández-Fradejas J, García Fernández S, Olmedo Samperio M, Cano Yuste A, Valencia Alijo A, Díaz-Pollán B, Rodríguez Hernández MJ, Merino De Lucas E, Martín Segarra O, Sáez Bejar C, Armiñanzas Castillo C, Gutiérrez Gutiérrez B, Rodríguez-Pardo D, Ramos Martínez A, De La Torre Cisneros J, López-Medrano F and Cobo Reinoso J
Publicada:
22 dic 2020
Ahead of Print:
22 dic 2020
Resumen:
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.
Filiaciones:
Escudero-Sánchez R:
Infectious disease Department, University Hospital Ramón y Cajal, 28034 Madrid, Spain
Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0011), Instituto de Salud Carlos III, 28029 Madrid, Spain
Ruíz-Ruizgómez M:
Infectious Disease Department, University Hospital 12 de Octubre, 28041 Madrid, Spain
Fernández-Fradejas J:
Pharmacy Department, University Hospital Ramón y Cajal, 28034 Madrid, Spain
García Fernández S:
Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0011), Instituto de Salud Carlos III, 28029 Madrid, Spain
Microbiology Department, University Hospital Ramón y Cajal, 28034 Madrid, Spain
Olmedo Samperio M:
Infectious Disease Department, University Hospital Gregorio Marañón, 28009 Madrid, Spain
Cano Yuste A:
Infectious Disease Department, University Hospital Reina Sofía, 14004 Córdoba, Spain
Valencia Alijo A:
Infectious Disease Department, University Hospital Puerta de Hierro, 28220 Majadahonda, Spain
Díaz-Pollán B:
Infectious Disease Department, University Hospital La Paz, 28046 Madrid, Spain
Rodríguez Hernández MJ:
Infectious Disease Department, University Hospital Virgen del Rocío, 41013 Sevilla, Spain
:
Unit of Infectious Diseases, Alicante General University Hospital - Alicante Institute of Sanitary and Biomedical Research (ISABIAL), 03012 Alicante, Spain
Martín Segarra O:
Internal Medicine Department, University Hospital Fundación Alcorcón, 28922 Alcorcón, Spain
Sáez Bejar C:
Infectious Disease Department, University Hospital La Princesa, 28008 Madrid, Spain
Armiñanzas Castillo C:
Infectious Disease Department, University Hospital Marqués de Valdecilla, 39008 Santander, Spain
Gutiérrez Gutiérrez B:
Infectious Disease Department, University Hospital Virgen Macarena, 41009 Sevilla, Spain
Rodríguez-Pardo D:
Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0011), Instituto de Salud Carlos III, 28029 Madrid, Spain
Infectious Disease Department, University Hospital Vall d'Hebron, 08035 Barcelona, Spain
Ramos Martínez A:
Infectious Disease Department, University Hospital Puerta de Hierro, 28220 Majadahonda, Spain
De La Torre Cisneros J:
Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0011), Instituto de Salud Carlos III, 28029 Madrid, Spain
Infectious Disease Department, University Hospital Reina Sofía, 14004 Córdoba, Spain
López-Medrano F:
Infectious Disease Department, University Hospital 12 de Octubre, 28041 Madrid, Spain
Department of Medicine, School of Medicine, UCM. Instituto de Investigación Biomédica i+12, 28040 Madrid, Spain
Cobo Reinoso J:
Infectious disease Department, University Hospital Ramón y Cajal, 28034 Madrid, Spain
Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0011), Instituto de Salud Carlos III, 28029 Madrid, Spain
Gold, Green Published
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