Bezlotoxumab is associated with a reduction in cumulative inpatient-days: Analysis of the hospitalization data from the MODIFY I and II clinical trials

Anirban Basu, Vimalanand S. Prabhu, Mary Beth Dorr, Yoav Golan, Erik R. Dubberke, Oliver A. Cornely, Sebastian M. Heimann, Alison Pedley, Ruifeng Xu, Mary E. Hanson, Stephen Marcella

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Background. Patients with recurrent Clostridium difficile infection (rCDI) are more likely to have a hospital readmission and spend increased time in inpatient settings compared with patients with primary CDI. MODIFY I and II demonstrated that bezlotoxumab significantly reduced rCDI vs placebo. A post hoc within-trial analysis assessed whether bezlotoxumab was associated with a reduction in cumulative inpatient-days. Methods. Data were pooled from the MODIFY trials to estimate the cumulative hospitalized days summed over the 84-day follow-up period. We adjusted inpatient use data from pooled MODIFY I and II for survival and censoring to estimate 84-day cumulative inpatient-days, overall and for subgroups. Treatment effects were obtained using recycled predictions based on trial protocol and rCDI risk, and 95% confidence intervals were obtained using 1000 bootstrap replicates. Results. Mean cumulative inpatient-days were greater in the placebo arm (14.1 days) vs the bezlotoxumab arm (12.1 days) in the overall population. The mean difference between treatment groups was 2.1 days (95% confidence interval, -0.4 to -3.7). This was consistent in participants with risk factors for rCDI: age ≥65 years, compromised immunity, severe CDI, prior CDI, and ribotype 027/078/244 infection. As the number of risk factors increased, bezlotoxumab resulted in greater reductions in the number of inpatient-days compared with placebo (difference: -1.2 days, -2.3 days, -2.5 days, and -3.0 days for 0, 1, 2, and ≥3 risk factors, respectively). Conclusions. Bezlotoxumab was associated with a reduction in cumulative inpatient-days, suggesting that treatment with bezlotoxumab may substantially reduce rCDI-associated health care resource use.

Original languageEnglish
JournalOpen Forum Infectious Diseases
Volume5
Issue number11
DOIs
StatePublished - Nov 1 2018

Keywords

  • CDI burden of disease
  • Clostridium difficile infection
  • Recurrence
  • Rehospitalization

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