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687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence

BACKGROUND: Describe real world experience in the use of bezlotoxumab (BZT) for the prevention of recurrent Clostridioides difficile(CDI) infection with a 1 year follow up following administration. The original BZT studies showed approximately 16% rate of recurrence at 12 weeks with other baseline a...

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Autores principales: Jacobs, Micah, Morris, Sharon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678254/
http://dx.doi.org/10.1093/ofid/ofad500.749
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author Jacobs, Micah
Morris, Sharon
author_facet Jacobs, Micah
Morris, Sharon
author_sort Jacobs, Micah
collection PubMed
description BACKGROUND: Describe real world experience in the use of bezlotoxumab (BZT) for the prevention of recurrent Clostridioides difficile(CDI) infection with a 1 year follow up following administration. The original BZT studies showed approximately 16% rate of recurrence at 12 weeks with other baseline and outcome data as noted in Figure 1. [Figure: see text] METHODS: Retrospective study of patients administered BZT in a community based private practice infusion suite from May 2017 to October 2020. A total of 50 consecutive patients were included with background demographics, relevant medical history and CDI history obtained through chart review. In addition to the chart review, patients were contacted at least 1 year after BZT administration to see if there were any recurrences and if other treatments were required. Primary objective was to show the rate of CDI recurrence in the 1 year after BZT administration. All BZT was administered in an outpatient setting in patients who were responding to initial Standard of care (SOC) therapy. RESULTS: 50 patients were included with infusion dates from May 2017 to October 2020. Baseline patient characteristics (Figure 2) include median Age of 69 and 74% female. CDI history (Figure 3) includes an average of 2.06 episodes including the current episode at time of time treatment and median of 19.5 days to BZT administration from last positive episode (positive test or starting a new treatment course for presumed positive). SOC treatments over the course of patient’s episodes are listed in Figure 3, most patients received more than agent. In the 1 year following BZT only 4 patients had recurrence (Figure 4) with 2 going on fecal microbiota transplant. There were 3 deaths reported, all at least 3 months after BZT and none had CDI recurrence. [Figure: see text] [Figure: see text] [Figure: see text] CONCLUSION: In our real-world use, BZT administered in an outpatient setting to patients who responded to SOC treatment resulted in only 8% recurrence after 1 year compared to 16% after 12 weeks in the trial. This supports the existing guidelines on the use of BZT in patients over 65 and with recurrent CDI to prevent further recurrence. Our data also supports administration later in the course of therapy when patients have achieved initial response. DISCLOSURES: MICAH JACOBS, Micah Jacobs, MD, FIDSA, FACP, Abbvie: Honoraria|Cumberland Pharmaceuticals: Honoraria|Merck: Grant/Research Support|Spero Pharmaceuticals: Advisor/Consultant
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spelling pubmed-106782542023-11-27 687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence Jacobs, Micah Morris, Sharon Open Forum Infect Dis Abstract BACKGROUND: Describe real world experience in the use of bezlotoxumab (BZT) for the prevention of recurrent Clostridioides difficile(CDI) infection with a 1 year follow up following administration. The original BZT studies showed approximately 16% rate of recurrence at 12 weeks with other baseline and outcome data as noted in Figure 1. [Figure: see text] METHODS: Retrospective study of patients administered BZT in a community based private practice infusion suite from May 2017 to October 2020. A total of 50 consecutive patients were included with background demographics, relevant medical history and CDI history obtained through chart review. In addition to the chart review, patients were contacted at least 1 year after BZT administration to see if there were any recurrences and if other treatments were required. Primary objective was to show the rate of CDI recurrence in the 1 year after BZT administration. All BZT was administered in an outpatient setting in patients who were responding to initial Standard of care (SOC) therapy. RESULTS: 50 patients were included with infusion dates from May 2017 to October 2020. Baseline patient characteristics (Figure 2) include median Age of 69 and 74% female. CDI history (Figure 3) includes an average of 2.06 episodes including the current episode at time of time treatment and median of 19.5 days to BZT administration from last positive episode (positive test or starting a new treatment course for presumed positive). SOC treatments over the course of patient’s episodes are listed in Figure 3, most patients received more than agent. In the 1 year following BZT only 4 patients had recurrence (Figure 4) with 2 going on fecal microbiota transplant. There were 3 deaths reported, all at least 3 months after BZT and none had CDI recurrence. [Figure: see text] [Figure: see text] [Figure: see text] CONCLUSION: In our real-world use, BZT administered in an outpatient setting to patients who responded to SOC treatment resulted in only 8% recurrence after 1 year compared to 16% after 12 weeks in the trial. This supports the existing guidelines on the use of BZT in patients over 65 and with recurrent CDI to prevent further recurrence. Our data also supports administration later in the course of therapy when patients have achieved initial response. DISCLOSURES: MICAH JACOBS, Micah Jacobs, MD, FIDSA, FACP, Abbvie: Honoraria|Cumberland Pharmaceuticals: Honoraria|Merck: Grant/Research Support|Spero Pharmaceuticals: Advisor/Consultant Oxford University Press 2023-11-27 /pmc/articles/PMC10678254/ http://dx.doi.org/10.1093/ofid/ofad500.749 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstract
Jacobs, Micah
Morris, Sharon
687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence
title 687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence
title_full 687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence
title_fullStr 687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence
title_full_unstemmed 687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence
title_short 687. Zinplava Expert Retrospective Observations (ZERO) Study Findings on Clostridioides difficile Recurrence
title_sort 687. zinplava expert retrospective observations (zero) study findings on clostridioides difficile recurrence
topic Abstract
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678254/
http://dx.doi.org/10.1093/ofid/ofad500.749
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