Bezlotoxumab: A Novel Agent for the Prevention of Recurrent Clostridium difficile Infection

Pharmacotherapy. 2017 Oct;37(10):1298-1308. doi: 10.1002/phar.1990. Epub 2017 Sep 12.

Abstract

During the past decade, the incidence and severity of Clostridium difficile infection (CDI) have significantly increased, leading to a rise in CDI-associated hospitalizations, health care costs, and mortality. Although treatment options exist for CDI, recurrence is frequent following treatment. Furthermore, patients with at least one CDI recurrence are at an increased risk of developing additional recurrences. A novel approach to the prevention of recurrent CDI is the use of monoclonal antibodies directed against the toxins responsible for CDI as an adjunct to antibiotic treatment. Bezlotoxumab, a human monoclonal antibody that binds and neutralizes C. difficile toxin B, is the first therapeutic agent to receive United States Food and Drug Administration approval for the prevention of CDI recurrence. Clinical studies have demonstrated superior efficacy of bezlotoxumab in adults receiving antibiotic therapy for CDI compared with antibiotic therapy alone for the prevention of CDI recurrence. Bezlotoxumab was well tolerated in clinical trials, with the most common adverse effects being nausea, vomiting, fatigue, pyrexia, headache, and diarrhea. The demonstrated efficacy, safety, and characteristics of bezlotoxumab present an advance in prevention of CDI recurrence.

Keywords: Clostridium difficile; Clostridium difficile infection; Clostridium difficile prevention; antitoxin; bezlotoxumab; monoclonal antibody.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Neutralizing / administration & dosage
  • Antibodies, Neutralizing / adverse effects
  • Antibodies, Neutralizing / therapeutic use*
  • Bacterial Proteins / antagonists & inhibitors*
  • Bacterial Toxins / antagonists & inhibitors*
  • Broadly Neutralizing Antibodies
  • Clinical Trials, Phase III as Topic
  • Clostridioides difficile / drug effects*
  • Clostridium Infections / epidemiology
  • Clostridium Infections / prevention & control*
  • Half-Life
  • Humans
  • Infusions, Intravenous
  • Recurrence
  • Secondary Prevention
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Antibodies, Neutralizing
  • Bacterial Proteins
  • Bacterial Toxins
  • Broadly Neutralizing Antibodies
  • toxB protein, Clostridium difficile
  • bezlotoxumab