Efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy for Clostridium difficile infection

Thomas Birch, Yoav Golan, Giuliano Rizzardini, Erin Jensen, Lori Gabryelski, Dalya Guris, Mary Beth Dorr

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Background: The fully human monoclonal antibody bezlotoxumab binds Clostridioides (Clostridium) difficile toxin B and reduces recurrence rates in patients with C. difficile infection (CDI) receiving antibacterial treatment for a primary or recurrent episode. Objectives: To investigate whether the timing of bezlotoxumab administration relative to the onset of antibacterial treatment affected clinical outcome in the Phase 3 trials MODIFY I (NCT01241552) and MODIFY II (NCT01513239). Methods: Initial clinical cure and CDI recurrence rates of participants who received bezlotoxumab or placebo were summarized by timing of infusion relative to the start of antibacterial drug treatment for CDI: 0-2, 3-4 and ≥5 days after onset. Results: Of 1554 total participants, 649 (41.8%), 469 (30.1%) and 436 (28.1%) received an infusion 0-2, 3-4 and ≥5 days after onset of antibacterial treatment for CDI, respectively. Regardless of timing of administration, there were no differences in initial clinical cure rates between participants receiving bezlotoxumab (range 77.8% to 81.4%) or placebo (77.8% to 81.7%). Bezlotoxumab efficacy was unaffected by timing of administration; rates of CDI recurrence were lower versus placebo in all subgroups (range 19.3% to 22.8% for bezlotoxumab and 31.7% to 35.8% for placebo). Timing of administration also had no effect on time to resolution of diarrhoea, which was achieved by the end of antibacterial treatment in ∼95% of participants in both bezlotoxumab and placebo groups. Conclusions: Bezlotoxumab is effective in preventing CDI recurrence and can be administered at any time before ending antibacterial drug treatment.

Original languageEnglish
Pages (from-to)2524-2528
Number of pages5
JournalJournal of Antimicrobial Chemotherapy
Volume73
Issue number9
DOIs
StatePublished - 1 Sep 2018
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology
  • Microbiology (medical)
  • Infectious Diseases
  • Pharmacology (medical)

Fingerprint

Dive into the research topics of 'Efficacy of bezlotoxumab based on timing of administration relative to start of antibacterial therapy for Clostridium difficile infection'. Together they form a unique fingerprint.

Cite this