[Source: Clinical Infectious Diseases, full page: (LINK). Abstract, edited.]
Antibodies to Toxin B Are Protective Against Clostridium difficile Infection Recurrence
Swati B. Gupta1, Vinay Mehta2, Erik R. Dubberke3, Xuemei Zhao4, Mary Beth Dorr5, Dalya Guris5, Deborah Molrine6,7, Mark Leney7,8, Mark Miller9, Marilyne Dupin10, and T. Christopher Mast2
Author Affiliations: 1Public Health and Scientific Affairs – 2Pharmacoepidemiology, Merck & Co, Inc, Kenilworth, New Jersey – 3Division of Infectious Diseases, Washington University School of Medicine, St Louis, Missouri – 4Translational Molecular Biomarkers – 5Clinical Research, Merck & Co, Inc, Kenilworth, New Jersey – 6Department of Pediatrics, University of Massachusetts Medical School, Worcester
7MassBiologics, Boston – 8Department of Medicine, University of Massachusetts Medical School, Worcester – 9Office of Medical and Scientific Affairs – 10Medical Diagnostics Discovery Department, bioMérieux, Marcy L’Etoile, France
Correspondence: S. B. Gupta, Merck & Co, Inc., 770 Sumneytown Pike, West Point, PA 19486 (firstname.lastname@example.org).
Although newer studies have evaluated risk factors for recurrent Clostridium difficile infection (CDI), the vast majority did not measure important biomarkers such as endogenous anti–toxin A and anti–toxin B antibody levels.
Data from the placebo group of a phase 2 trial testing monoclonal antibodies to C. difficile toxins A and B for preventing CDI recurrence (rCDI) were analyzed to assess risk factors associated with rCDI. Patients with symptomatic CDI taking metronidazole or vancomycin were enrolled. The primary outcome was rCDI within 84 days of treatment start. Univariate and multivariate logistic regression was used to examine associations between potential risk factors and rCDI. At baseline, demographic and clinical characteristics were recorded; endogenous antibody levels were assessed using 2 enzyme-linked immunosorbent assays.
A predictor of recurrence was age ≥65 years, and an antibody-mediated immune response to toxin B appears to be protective against rCDI.
Our findings demonstrate the importance of clinical as well as immunological risk factors in rCDI and provide more robust evidence for the protective effects of antibody to toxin B in the prevention of rCDI.
Clinical Trials Registration. NCT00350298.
Key words: epidemiology – risk factors – antibodies – toxin A – serology
10.1093/cid/ciw366 Received February 15, 2016.
Accepted May 7, 2016.
© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail email@example.com.
Keywords: Research; Abstracts; Clostridium Difficile.