Universität zu Köln

Cornely, Oliver A., Mullane, Kathleen M., Birch, Thomas, Hazan-Steinberg, Sabine, Nathan, Richard, Bouza, Emilio, Calfee, David P., Ellison, Misoo Chung, Wong, Michael T. and Dorr, Mary Beth (2020). Exploratory Evaluation of Bezlotoxumab on Outcomes Associated With Clostridioides difficile Infection in MODIFY I/II Participants With Cancer. Open Forum Infect. Dis., 7 (2). CARY: OXFORD UNIV PRESS INC. ISSN 2328-8957

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Abstract

Background. The incidence of Clostridioides dtfficile infection (CDI) is reportedly higher and the cure rate lower in individuals with cancer vs those without cancer. An exploratory post hoc analysis of the MODIFY I/II trials (NCT01241552/NCT01513239) investigated how bezlotoxumab affected the rate of CDI-related outcomes in participants with cancer. Methods. Participants received a single infusion of bezlotoxumab (10 mg/kg) or placebo during anti-CDI antibacterial treatment. A post hoc analysis of CDI-related outcomes was conducted in subgroups of MODIFY I/II participants with and without cancer. Results. Of 1554 participants in the modified intent-to-treat (mITT) population, 382 (24.6%) were diagnosed with cancer (bezlotoxumab 190, placebo 192). Of participants without cancer, 591 and 581 received bezlotoxumab and placebo, respectively. In the placebo group, initial clinical cure (ICC) was achieved by fewer cancer participants vs participants without cancer (71.9% vs 83.1%; absolute difference, -11.3%; 95% CI, -18.6% to -4.5%); however, CDI recurrence (rCDI) rates were similar in cancer (30.4%) and noncancer (34.0%) participants. In participants with cancer, bezlotoxumab treatment had no effect on ICC rate compared with placebo (76.8% vs 71.9%), but resulted in a statistically significant reduction in rCDI vs placebo (17.8% vs 30.4%; absolute difference, -12.6%; 95% CI, -22.5% to -2.7%). Conclusions. In this post hoc analysis of participants with cancer enrolled in MODIFY I/II, the rate of rCDI in bezlotoxumabtreated participants was lower than in placebo-treated participants. Additional studies are needed to confirm these results.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mullane, Kathleen M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Birch, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Hazan-Steinberg, Sabine UNSPECIFIED UNSPECIFIED UNSPECIFIED Nathan, Richard UNSPECIFIED UNSPECIFIED UNSPECIFIED Bouza, Emilio UNSPECIFIED UNSPECIFIED UNSPECIFIED Calfee, David P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ellison, Misoo Chung UNSPECIFIED UNSPECIFIED UNSPECIFIED Wong, Michael T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dorr, Mary Beth UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-346044
DOI:	10.1093/ofid/ofaa038
Journal or Publication Title:	Open Forum Infect. Dis.
Volume:	7
Number:	2
Date:	2020
Publisher:	OXFORD UNIV PRESS INC
Place of Publication:	CARY
ISSN:	2328-8957
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language STEM-CELL TRANSPLANT; EPIDEMIOLOGY; FIDAXOMICIN; VANCOMYCIN; DIARRHEA; BURDEN; ADULTS; IMPACT Multiple languages Immunology; Infectious Diseases; Microbiology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/34604