@article{6f302353504b4954bc01d73de00c0dad,
title = "Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence",
abstract = "Background. Bezlotoxumab is a human monoclonal antibody against Clostridium difficile toxin B indicated to prevent C. difficile infection (CDI) recurrence (rCDI) in adults at high risk for rCDI. This post hoc analysis of pooled monocolonal antibodies for C. difficile therapy (MODIFY) I/II data assessed bezlotoxumab efficacy in participants with characteristics associated with increased risk for rCDI. Methods. The analysis population was the modified intent-to-treat population who received bezlotoxumab or placebo (n = 1554) by risk factors for rCDI that were prespecified in the statistical analysis plan: age =65 years, history of CDI, compromised immunity, severe CDI, and ribotype 027/078/244. The proportion of participants with rCDI in 12 weeks, fecal microbiota transplant procedures, 30-day all cause and CDI-associated hospital readmissions, and mortality at 30 and 90 days after randomization were presented. Results. The majority of enrolled participants (75.6%) had =1 risk factor; these participants were older and a higher proportion had comorbidities compared with participants with no risk factors. The proportion of placebo participants who experienced rCDI exceeded 30% for each risk factor compared with 20.9% among those without a risk factor, and the rCDI rate increased with the number of risk factors (1 risk factor: 31.3%; =3 risk factors: 46.1%). Bezlotoxumab reduced rCDI, fecal microbiota transplants, and CDI-associated 30-day readmissions in participants with risk factors for rCDI. Conclusions. The risk factors prespecified in the MODIFY statistical analysis plan are appropriate to identify patients at high risk for rCDI. While participants with =3 risk factors had the greatest reduction of rCDI with bezlotoxumab, those with 1 or 2 risk factors may also benefit.",
keywords = "C. difficile infection, CDI, bezlotoxumab., recurrence",
author = "Gerding, {Dale N.} and Kelly, {Ciaran P.} and Galia Rahav and Christine Lee and Dubberke, {Erik R.} and Kumar, {Princy N.} and Bruce Yacyshyn and Dina Kao and Karen Eves and Ellison, {Misoo C.} and Hanson, {Mary E.} and Dalya Guris and Dorr, {Mary Beth}",
note = "Funding Information: Potential conflicts of interest. D. N. G. has received fees for serving on advisory boards from Actelion Pharmaceuticals, Rebiotix, Summit Pharmaceuticals, and Merck; has received consulting fees from Da Volterra, Pfizer, Sanofi Pasteur, and MGB Pharma; has received a research grant from Seres Therapeutics; and has issued patents related to the treatment and prevention of CDI (US patent number 6 635 260; European Union patent number 0952773; Canada patent number 2232001). C. P. K. has served as a scientific advisor for Facile Therapeutics, Summit (Oxford), Synthetic Biologics, Actelion, First Light Diagnostics, Finch, GlaxoSmithKline, Merck, Seres Therapeutics, CellImmune, Core Pharma, Takeda, Innovate, Immunogenex, and Vedanta; has received lecture fees from Merck and Seres Therapeutics; and has received grant support from the National Institutes of Health, Institut M{\'e}rieux, Aptalis, and Merck. G. R. has received fees for lectures and advisory board membership from Pfizer and Merck Sharp & Dohme. C. L. has received grant support from Rebiotix, Merck, and Actelion Pharmaceuticals and fees for serving on advisory boards from Rebiotix and Summit Pharmaceuticals. E. R. D. is an investigator on behalf of Merck & Co, Inc and Rebiotix; has received grants from Sanofi Pasteur; and is a consultant for Merck & Co, Inc, GSK, Velneva, Rebiotix, and Sanofi Pasteur. P. N. K. has served on advisory boards for Gilead, Johnson & Johnson, GSK, Theratechnolgies and Gilead; and holds stock in Gilead, Johnson & Johnson, Pfizer, Merck, and GSK. B. Y. has served on speaker{\textquoteright}s bureaus for Allergan, Merck, and UCB; is an advisory board member for Summit and a data and safety monitoring board member for Seres; has received grant support and travel support from Merck; and has served as a consultant for Aerpio. D. K. has received grant support from Rebiotix. K. E., M. C. E., M. E. H., D. G., and M. B. D. are employees of Merck & Co, Inc, Kenilworth, New Jersey, and may own stock or hold stock options in the company. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Funding Information: Financial support. This work was supported by Merck & Co, Inc, Kenilworth, New Jersey. Publisher Copyright: {\textcopyright} The Author(s) 2018.",
year = "2018",
month = aug,
day = "16",
doi = "10.1093/cid/ciy171",
language = "English",
volume = "67",
pages = "649--656",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
number = "5",
}