Fidaxomicin monotherapy versus standard therapy combined with bezlotoxumab for treating patients with Clostridioides difficile infection at high risk of recurrence: a matched cohort study

Author:

Escudero-Sanchez Rosa123ORCID,Muriel García Alfonso34,García Fernández Sergio25,Valencia Alijo Angela6,Tasias Pitarch Mariona7,Merino De Lucas Esperanza8,Gutierrez Rojas Angela6,Ramos Martínez Antonio6,Salavert Lletí Miguel7,Giner Livia8,Ruíz Ruigomez María9,García Basas Lorena10,Fernández Fradejas Jorge310ORCID,Olmedo Sampedrio María11,Cano Yuste Angela12,Díaz Pollán Beatriz13ORCID,Rodríguez Hernández María Jesús14,Martín Segarra Oriol15,Sáez Bejar Carmen16,Armiñanzas Castillo Carlos17,Gutiérrez Belén18ORCID,Rodríguez-Pardo Dolors219ORCID,De La Torre Cisneros Julián212,López Medrano Francisco9,Cobo Reinoso Javier123

Affiliation:

1. Infectious Disease Department, University Hospital Ramon y Cajal , Madrid , Spain

2. Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0011), Instituto de Salud Carlos III , Madrid , Spain

3. Instituto Ramón y Cajal Investigación Sanitaria (IRYCIS) , Madrid , Spain

4. Biostatistics Unit, University Hospital Ramon y Cajal, Centro de Investigación Biomédica en Red, Epidemiología y Salúd Pública (CIBERESP), Universidad de Alcalá , Madrid , Spain

5. Microbiology Department, University Hospital Ramon y Cajal , Madrid , Spain

6. Internal Medicine Department, University Hospital Puerta de Hierro , Majadahonda , Spain

7. Infectious Disease Unit, University Hospital La Fe , Valencia , Spain

8. Internal Medicine Department, University Hospital General Alicante , Alicante , Spain

9. Internal Medicine Department, University Hospital 12 de Octubre , Madrid , Spain

10. Pharmacy Department, University Hospital Ramon y Cajal , Madrid , Spain

11. Internal Medicine Department, University Hospital Gregorio Marañón , Madrid , Spain

12. Internal Medicine Department, University Hospital Reina Sofía , Córdoba , Spain

13. Internal Medicine Department, University Hospital La Paz , Madrid , Spain

14. Internal Medicine Department, University Hospital Virgen del Rocío , Sevilla , Spain

15. Internal Medicine Department, University Hospital Fundación Alcorcón , Alcorcón , Spain

16. Internal Medicine Department, University Hospital La Princesa , Madrid , Spain

17. Infectious Disease Department, University Hospital Marqués de Valdecilla , Santander , Spain

18. Internal Medicine Department, University Hospital Virgen Macarena , Sevilla , Spain

19. Servei de Malaties Infeccioses, Vall d’Hebron Hospital Universitari , Barcelona , Spain

Abstract

Abstract Background Both fidaxomicin and bezlotoxumab (used in combination with an antibiotic against Clostridioides difficile) achieve reductions in recurrence rates of C. difficile infection (CDI). However, the two strategies have never been compared. Methods Data from two retrospective cohorts of ‘real-life’ use of fidaxomicin and bezlotoxumab in combination with a standard anti-C. difficile antibiotic were used to compare the rates of recurrence of both strategies. Since the two cohorts were not identical, we used a propensity score analysis. Results Three hundred and two patients were included: 244 in the fidaxomicin cohort and 78 in the bezlotoxumab cohort. A history of renal failure or immunosuppression was more frequent in patients receiving bezlotoxumab (39.7% and 66.7% versus 26.6% and 38.9%; P = 0.03 and P < 0.001, respectively), but the severity and number of previous CDI episodes were similar in both cohorts. We observed that 19.3% of the patients in the fidaxomicin cohort experienced recurrence, compared with 14.1% in the bezlotoxumab cohort (OR 1.45; 95% CI 0.71–2.96; P = 0.29) but the difference remained non-significant after propensity score matching using previously defined variables (OR 1.24; 95% CI 0.50–3.07; P = 0.64). Moreover, the multivariate analysis did not show differences depending on the drug used. Conclusions We observed that fidaxomicin and bezlotoxumab are prescribed in similar clinical scenarios, although those treated with bezlotoxumab have greater comorbidity. The proportion of recurrences was numerically lower in those treated with bezlotoxumab, although the propensity analysis did not find significant differences between the two drugs.

Funder

Instituto de Salud Carlos III

Subdirección General de Redes y Centros de Investigación Cooperativa

Ministerio de Ciencia, Innovación y Universidades

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)

Reference25 articles.

1. Bezlotoxumab for prevention of recurrent Clostridium difficile infection;Wilcox;N Engl J Med,2017

2. Fidaxomicin versus vancomycin for Clostridium difficile infection;Louie;N Engl J Med,2011

3. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial;Cornely;Lancet Infect Dis,2012

4. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 focused update guidelines on management of Clostridioides difficile infection in adults;Johnson;Infect Dis Soc Am,2021

5. The efficacy of fidaxomicin in the treatment of Clostridium difficile infection in a real-world clinical setting: a Spanish multi-centre retrospective cohort;Fehér;Eur J Clin Microbiol Infect Dis,2017

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