Abstract
The MODIFY I/II trials demonstrated that bezlotoxumab, a human monoclonal antibody against Clostridioides difficile toxin B, given during antibiotic treatment for Clostridioides difficile infection (CDI) significantly reduced C. difficile recurrence (rCDI) in adults at high risk for rCDI. Efficacy of CDI-directed intervention may depend on ribotype regional epidemiology, and patient characteristics. This post hoc analysis assessed the efficacy of bezlotoxumab in the subgroup of MODIFY I/II trial participants enrolled in Europe. Data from the bezlotoxumab (10 mg/kg single intravenous infusion) and placebo (0.9% saline) groups from MODIFY I/II were compared to assess initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality through 12 weeks post-infusion. Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48%). Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%). Fifty-five percent of participants were female, and 86% were hospitalized at randomization. The rate of ICC was similar between treatment groups. The rate of rCDI in the bezlotoxumab group was lower compared with placebo among European participants overall, and among those with ≥ 1 risk factor for rCDI. Bezlotoxumab reduced 30-day CDI-associated rehospitalizations compared with placebo. These results are consistent with overall results from the MODIFY trials and demonstrate that bezlotoxumab reduces rCDI and CDI-associated rehospitalizations in European patients with CDI. MODIFY I/II (NCT01241552 and NCT01513239)
Highlights
IntroductionEuropean countries, accounting for 3.6% of all hospital-acquired infections (HAIs) and 48% of all gastro-intestinal infections, both HA and non-HA (excluding hepatitis) [1]
Clostridioides difficile infection (CDI) is one of the most frequently reported hospital-acquired infections (HAIs) in of Internal Medicine, Excellence Center for Medical Mycology (ECMM); Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD); Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Cologne, Germany 3 Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain 4 University of Rzeszów Medical Center, Łańcut, Poland 5 Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USAEuropean countries, accounting for 3.6% of all HAIs and 48% of all gastro-intestinal infections, both HA and non-HA [1]
The phase 3 MODIFY I and II trials demonstrated that bezlotoxumab, a human monoclonal antibody against C. difficile toxin B, when given during standard of care (SOC) antibiotic treatment for an active CDI, significantly reduced rCDI in adults at high risk for rCDI [13, 14]
Summary
European countries, accounting for 3.6% of all HAIs and 48% of all gastro-intestinal infections, both HA and non-HA (excluding hepatitis) [1]. With such high incidence rates, healthcare resource use and attributable financial burden of CDI are significant, mainly driven by length of hospital stay [2,3,4]. The phase 3 MODIFY I and II trials demonstrated that bezlotoxumab, a human monoclonal antibody against C. difficile toxin B, when given during standard of care (SOC) antibiotic treatment for an active CDI, significantly reduced rCDI in adults at high risk for rCDI [13, 14]. Healthcare practices and reimbursement methods differed across the countries that enrolled patients in the MODIFY
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