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Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities

BACKGROUND: Advanced age and underlying comorbidities are associated with greater rates of recurrence in patients with Clostridioides difficile infection (CDI). Reducing the likelihood of recurrence through treatment with an antimicrobial followed by a microbiota replacement therapy can decrease the...

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Autores principales: Tillotson, Glenn, Archbald-Pannone, Laurie, Johnson, Stuart, Ng, Samson, Ando, Masakazu, Harvey, Adam, Bancke, Lindy, Feuerstadt, Paul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9846189/
https://www.ncbi.nlm.nih.gov/pubmed/36686631
http://dx.doi.org/10.1093/ofid/ofac703
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author Tillotson, Glenn
Archbald-Pannone, Laurie
Johnson, Stuart
Ng, Samson
Ando, Masakazu
Harvey, Adam
Bancke, Lindy
Feuerstadt, Paul
author_facet Tillotson, Glenn
Archbald-Pannone, Laurie
Johnson, Stuart
Ng, Samson
Ando, Masakazu
Harvey, Adam
Bancke, Lindy
Feuerstadt, Paul
author_sort Tillotson, Glenn
collection PubMed
description BACKGROUND: Advanced age and underlying comorbidities are associated with greater rates of recurrence in patients with Clostridioides difficile infection (CDI). Reducing the likelihood of recurrence through treatment with an antimicrobial followed by a microbiota replacement therapy can decrease the burden of this infection and improve patient outcomes. We report the efficacy and safety of RBX2660, a microbiota-based live biotherapeutic, in older adults with recurrent CDI, grouped by comorbidities. METHODS: In this post hoc subgroup analysis of the PUNCH CD3 trial, we assessed outcomes in older adults (age ≥65 years) grouped by Charlson Comorbidity Index severity scores at screening (moderate [3–4] and severe [≥5]) and by the presence of underlying cardiac, renal, or gastrointestinal disorders. RESULTS: RBX2660 treatment success rates in older adults with comorbidities were consistent across subgroups and similar to those in the total RBX2660-treated population. A greater percentage of RBX2660-treated older adults remained free of CDI recurrence through 8 weeks following treatment compared with placebo-treated participants in all but 2 subgroups assessed. Across all subgroups, most treatment-emergent adverse events (TEAEs) were mild or moderate in severity and related to a preexisting condition. None of the serious or life-threatening TEAEs that occurred were related to RBX2660 or its administration. Occurrence of TEAEs did not cluster in any subgroup. CONCLUSIONS: RBX2660 is efficacious and safe in older adults with recurrent CDI and underlying comorbidities.
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spelling pubmed-98461892023-01-20 Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities Tillotson, Glenn Archbald-Pannone, Laurie Johnson, Stuart Ng, Samson Ando, Masakazu Harvey, Adam Bancke, Lindy Feuerstadt, Paul Open Forum Infect Dis Major Article BACKGROUND: Advanced age and underlying comorbidities are associated with greater rates of recurrence in patients with Clostridioides difficile infection (CDI). Reducing the likelihood of recurrence through treatment with an antimicrobial followed by a microbiota replacement therapy can decrease the burden of this infection and improve patient outcomes. We report the efficacy and safety of RBX2660, a microbiota-based live biotherapeutic, in older adults with recurrent CDI, grouped by comorbidities. METHODS: In this post hoc subgroup analysis of the PUNCH CD3 trial, we assessed outcomes in older adults (age ≥65 years) grouped by Charlson Comorbidity Index severity scores at screening (moderate [3–4] and severe [≥5]) and by the presence of underlying cardiac, renal, or gastrointestinal disorders. RESULTS: RBX2660 treatment success rates in older adults with comorbidities were consistent across subgroups and similar to those in the total RBX2660-treated population. A greater percentage of RBX2660-treated older adults remained free of CDI recurrence through 8 weeks following treatment compared with placebo-treated participants in all but 2 subgroups assessed. Across all subgroups, most treatment-emergent adverse events (TEAEs) were mild or moderate in severity and related to a preexisting condition. None of the serious or life-threatening TEAEs that occurred were related to RBX2660 or its administration. Occurrence of TEAEs did not cluster in any subgroup. CONCLUSIONS: RBX2660 is efficacious and safe in older adults with recurrent CDI and underlying comorbidities. Oxford University Press 2022-12-30 /pmc/articles/PMC9846189/ /pubmed/36686631 http://dx.doi.org/10.1093/ofid/ofac703 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Major Article
Tillotson, Glenn
Archbald-Pannone, Laurie
Johnson, Stuart
Ng, Samson
Ando, Masakazu
Harvey, Adam
Bancke, Lindy
Feuerstadt, Paul
Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities
title Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities
title_full Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities
title_fullStr Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities
title_full_unstemmed Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities
title_short Microbiota-Based Live Biotherapeutic RBX2660 for the Reduction of Recurrent Clostridioides difficile Infection in Older Adults With Underlying Comorbidities
title_sort microbiota-based live biotherapeutic rbx2660 for the reduction of recurrent clostridioides difficile infection in older adults with underlying comorbidities
topic Major Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9846189/
https://www.ncbi.nlm.nih.gov/pubmed/36686631
http://dx.doi.org/10.1093/ofid/ofac703
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