TY - JOUR
T1 - Bezlotoxumab is associated with a reduction in cumulative inpatient-days
T2 - Analysis of the hospitalization data from the MODIFY I and II clinical trials
AU - Basu, Anirban
AU - Prabhu, Vimalanand S.
AU - Dorr, Mary Beth
AU - Golan, Yoav
AU - Dubberke, Erik R.
AU - Cornely, Oliver A.
AU - Heimann, Sebastian M.
AU - Pedley, Alison
AU - Xu, Ruifeng
AU - Hanson, Mary E.
AU - Marcella, Stephen
N1 - Publisher Copyright:
© The Author(s) 2018.
PY - 2018/11/1
Y1 - 2018/11/1
N2 - 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.
AB - 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.
KW - CDI burden of disease
KW - Clostridium difficile infection
KW - Recurrence
KW - Rehospitalization
UR - http://www.scopus.com/inward/record.url?scp=85068049383&partnerID=8YFLogxK
U2 - 10.1093/ofid/ofy218
DO - 10.1093/ofid/ofy218
M3 - Article
AN - SCOPUS:85068049383
SN - 2328-8957
VL - 5
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 11
ER -