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

Journal of Clinical Medicine

María Ruíz-Ruizgómez¹  Francisco López-Medrano¹  María Olmedo Samperio²  Beatriz Díaz-Pollán³  Carmen Sáez Bejar⁴  Carlos Armiñanzas Castillo⁵  Angela Valencia Alijo⁶  Antonio Ramos Martínez⁶  Angela Cano Yuste⁷  Belén Gutiérrez Gutiérrez⁸  MaríaJesús Rodríguez Hernández⁹  Javier Cobo Reinoso^1,10  Rosa Escudero-Sánchez^1,10  Oriol Martín Segarra^1,11  Jorge Fernández-Fradejas^1,12  Sergio García Fernández^1,13  Dolors Rodríguez-Pardo^1,13  Julián De La Torre Cisneros^1,13  Esperanza Merino De Lucas^1,14 

[1] Infectious Disease Department, University Hospital 12 de Octubre, 28041 Madrid, Spain;Infectious Disease Department, University Hospital Gregorio Marañón, 28009 Madrid, Spain;Infectious Disease Department, University Hospital La Paz, 28046 Madrid, Spain;Infectious Disease Department, University Hospital La Princesa, 28008 Madrid, Spain;Infectious Disease Department, University Hospital Marqués de Valdecilla, 39008 Santander, Spain;Infectious Disease Department, University Hospital Puerta de Hierro, 28220 Majadahonda, Spain;Infectious Disease Department, University Hospital Reina Sofía, 14004 Córdoba, Spain;Infectious Disease Department, University Hospital Virgen Macarena, 41009 Sevilla, Spain;Infectious Disease Department, University Hospital Virgen del Rocío, 41013 Sevilla, Spain;Infectious disease Department, University Hospital Ramón y Cajal, 28034 Madrid, Spain;Internal Medicine Department, University Hospital Fundación Alcorcón, 28922 Alcorcón, Spain;Pharmacy 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;Unit of Infectious Diseases, Alicante General University Hospital - Alicante Institute of Sanitary and Biomedical Research (ISABIAL), 03012 Alicante, Spain;

关键词: Clostridium difficile;    Clostridioides difficile;    C. difficile infection;    bezlotoxumab;    recurrence;   

DOI  :  10.3390/jcm10010002

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown