Universität zu Köln

Bouza, Emilio, Cornely, Oliver A., Ramos-Martinez, Antonio ORCID: 0000-0002-4840-9425, Plesniak, Robert, Ellison, Misoo C., Hanson, Mary E. and Dorr, Mary Beth (2020). Analysis of C. difficile infection-related outcomes in European participants in the bezlotoxumab MODIFY I and II trials. Eur. J. Clin. Microbiol. Infect. Dis., 39 (10). S. 1933 - 1940. NEW YORK: SPRINGER. ISSN 1435-4373

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Abstract

The MODIFY I/II trials demonstrated that bezlotoxumab, a human monoclonal antibody against Clostridioides difficile toxin B, given during antibiotic treatment for Clostridioides difficile infection (CDI) significantly reduced C. difficile recurrence (rCDI) in adults at high risk for rCDI. Efficacy of CDI-directed intervention may depend on ribotype regional epidemiology, and patient characteristics. This post hoc analysis assessed the efficacy of bezlotoxumab in the subgroup of MODIFY I/II trial participants enrolled in Europe. Data from the bezlotoxumab (10 mg/kg single intravenous infusion) and placebo (0.9% saline) groups from MODIFY I/II were compared to assess initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality through 12 weeks post-infusion. Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48%). Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%). Fifty-five percent of participants were female, and 86% were hospitalized at randomization. The rate of ICC was similar between treatment groups. The rate of rCDI in the bezlotoxumab group was lower compared with placebo among European participants overall, and among those with >= 1 risk factor for rCDI. Bezlotoxumab reduced 30-day CDI-associated rehospitalizations compared with placebo. These results are consistent with overall results from the MODIFY trials and demonstrate that bezlotoxumab reduces rCDI and CDI-associated rehospitalizations in European patients with CDI. MODIFY I/II (NCT01241552 and NCT01513239)

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Bouza, Emilio UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ramos-Martinez, Antonio UNSPECIFIED orcid.org/0000-0002-4840-9425 UNSPECIFIED Plesniak, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Ellison, Misoo C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hanson, Mary E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dorr, Mary Beth UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-330507
DOI:	10.1007/s10096-020-03935-3
Journal or Publication Title:	Eur. J. Clin. Microbiol. Infect. Dis.
Volume:	39
Number:	10
Page Range:	S. 1933 - 1940
Date:	2020
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1435-4373
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CLOSTRIDIUM-DIFFICILE; ECONOMIC BURDEN; HOSPITALS; RECURRENCES; FIDAXOMICIN; VANCOMYCIN; DIARRHEA; COST Multiple languages Infectious Diseases; Microbiology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/33050