Bezlotoxumab: anti-toxin B monoclonal antibody to prevent recurrence of Clostridium difficile infection

• Published in: Expert review of gastroenterology & hepatology Vol. 11; no. 7; p. 611
• Main Authors: Villafuerte Gálvez, Javier A, Kelly, Ciarán P
• Format: Journal Article
• Language: English
• Published: England 03.07.2017
• Subjects: Animals; Antibodies, Monoclonal - economics; Antibodies, Monoclonal - pharmacology; Antibodies, Monoclonal - therapeutic use; Antibodies, Neutralizing - economics; Antibodies, Neutralizing - pharmacology; Antibodies, Neutralizing - therapeutic use; Bacterial Proteins - immunology; Bacterial Toxins - immunology; Clostridium difficile; Economic Competition; Enterocolitis, Pseudomembranous - epidemiology; Enterocolitis, Pseudomembranous - prevention & control; Humans; Recurrence; Secondary Prevention - methods; recurrence; clostridium difficile infection; clostridium difficile; immunotherapy; Monoclonal antibodies; bezlototumab; antibiotic associated diarrhea
• ISSN: 1747-4132
• DOI: 10.1080/17474124.2017.1344551

Clostridium difficile infection (CDI) is the most common nosocomial infection in the U.S. 25% of CDI patients go on to develop recurrent CDI (rCDI) following current standard of care (SOC) therapy, leading to morbidity, mortality and economic loss. The first passive immunotherapy drug targeting C.difficile toxin B (bezlotoxumab) has been approved recently by the FDA and EMA for prevention of rCDI. Areas covered: A body of key studies was selected and reviewed by the authors. The unmet needs in CDI care were ascertained with emphasis in rCDI, including the epidemiology, pathophysiology and current management. The current knowledge about the immune response to C. difficile toxins and how this knowledge led to the development and the clinical use of bezlotoxumab is described. Current and potential future competitors to the drug were examined. Expert commentary: A single 10 mg/kg intravenous infusion of bezlotoxumab has been shown to decrease rCDI by ~40% (absolute reduction ~10%) in patients being treated for primary CDI or rCDI with SOC antibiotics. Targeting C.difficile toxins by passive immunotherapy is a novel mechanism for prevention of C.difficile infection. Bezlotoxumab will be a valuable adjunctive therapy to reduce the burden of CDI.