Cargando…

1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies

BACKGROUND: Emergency use of tixagevimab-cilgavimab was based on data collected prior to the emergence of SARS-CoV-2 omicron variant and subvariants. Dosing recommendations changed twice based on neutralization data alone, leading to patients receiving different doses at varying intervals. We provid...

Descripción completa

Detalles Bibliográficos
Autores principales: Dluzynski, Daniela, Ssentongo, Paddy, Shaheen, Shareef, Maglakelidze, Natella, Hale, Cory, Henao, Maria Paula, Chinchilli, Vernon M, Paules, Catharine I
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678513/
http://dx.doi.org/10.1093/ofid/ofad500.1176
_version_ 1785150379590156288
author Dluzynski, Daniela
Ssentongo, Paddy
Shaheen, Shareef
Maglakelidze, Natella
Hale, Cory
Henao, Maria Paula
Chinchilli, Vernon M
Paules, Catharine I
author_facet Dluzynski, Daniela
Ssentongo, Paddy
Shaheen, Shareef
Maglakelidze, Natella
Hale, Cory
Henao, Maria Paula
Chinchilli, Vernon M
Paules, Catharine I
author_sort Dluzynski, Daniela
collection PubMed
description BACKGROUND: Emergency use of tixagevimab-cilgavimab was based on data collected prior to the emergence of SARS-CoV-2 omicron variant and subvariants. Dosing recommendations changed twice based on neutralization data alone, leading to patients receiving different doses at varying intervals. We provide real-world data on efficacy of tixagevimab-cilgavimab in immunocompromised patients throughout 2022, including the incidence and timing of infection based on dosing scheme. METHODS: Charts of 471 patients who received and 126 patients who declined administration of tixagevimab-cilgavimab were analyzed through December 14(th), 2022. We evaluated incidence of SARS-CoV2, severity, risk factors and vaccination status. For analysis, we grouped patients with similar dosing: Group A received one initial dose of 150mg/150mg of tixagevimab-cilgavimab, Group B received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1(st), and Group C patients were up to date with the FDA dosing guidelines. RESULTS: The tixagevimab-cilgavimab group had higher incidence of stem cell transplant or CAR T-cell therapy (115/471, 24% compared to 18/126, 14% p < 0.01) and had higher vaccination status (411/471, 89% compared to 37/126, 29%, p < 0.0001). Patients that received tixagevimab-cilgavimab had a trend towards higher incidence of SARS-CoV-2 infection (70/471, 15% compared to 11/126, 9%; p = 0.08). Incidence of SARS-CoV-2 was similar amongst all dosing groups (6/21, 29% in Group A; 37/251, 15% in Group B, and 27/199, 14% in Group C, p = 0.188). Group C experienced the most infections in November and early December 2022. [Figure: see text] Group A patients received one initial dose of 150 mg/150mg of tixagevimab-cilgavimab. Group B patients received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1st, 2022 . Group C patients were up to date with the FDA dosing guidelines. CONCLUSION: The tixagevimab-cilgavimab group demonstrated increased incidence of SARS-CoV-2. This may reflect increased healthcare system utilization, as most infections were self-reported in this study. Those with the FDA recommended dose were most likely to develop SARS-CoV-2 in November and December 2022 when circulating variants were not neutralized by tixagevimab-cilgavimab in vitro. This suggests in vitro neutralization data correlates with clinical efficacy. DISCLOSURES: All Authors: No reported disclosures
format Online
Article
Text
id pubmed-10678513
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-106785132023-11-27 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies Dluzynski, Daniela Ssentongo, Paddy Shaheen, Shareef Maglakelidze, Natella Hale, Cory Henao, Maria Paula Chinchilli, Vernon M Paules, Catharine I Open Forum Infect Dis Abstract BACKGROUND: Emergency use of tixagevimab-cilgavimab was based on data collected prior to the emergence of SARS-CoV-2 omicron variant and subvariants. Dosing recommendations changed twice based on neutralization data alone, leading to patients receiving different doses at varying intervals. We provide real-world data on efficacy of tixagevimab-cilgavimab in immunocompromised patients throughout 2022, including the incidence and timing of infection based on dosing scheme. METHODS: Charts of 471 patients who received and 126 patients who declined administration of tixagevimab-cilgavimab were analyzed through December 14(th), 2022. We evaluated incidence of SARS-CoV2, severity, risk factors and vaccination status. For analysis, we grouped patients with similar dosing: Group A received one initial dose of 150mg/150mg of tixagevimab-cilgavimab, Group B received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1(st), and Group C patients were up to date with the FDA dosing guidelines. RESULTS: The tixagevimab-cilgavimab group had higher incidence of stem cell transplant or CAR T-cell therapy (115/471, 24% compared to 18/126, 14% p < 0.01) and had higher vaccination status (411/471, 89% compared to 37/126, 29%, p < 0.0001). Patients that received tixagevimab-cilgavimab had a trend towards higher incidence of SARS-CoV-2 infection (70/471, 15% compared to 11/126, 9%; p = 0.08). Incidence of SARS-CoV-2 was similar amongst all dosing groups (6/21, 29% in Group A; 37/251, 15% in Group B, and 27/199, 14% in Group C, p = 0.188). Group C experienced the most infections in November and early December 2022. [Figure: see text] Group A patients received one initial dose of 150 mg/150mg of tixagevimab-cilgavimab. Group B patients received at least 300 mg/300 mg of tixagevimab-cilgavimab before July 1st, 2022 . Group C patients were up to date with the FDA dosing guidelines. CONCLUSION: The tixagevimab-cilgavimab group demonstrated increased incidence of SARS-CoV-2. This may reflect increased healthcare system utilization, as most infections were self-reported in this study. Those with the FDA recommended dose were most likely to develop SARS-CoV-2 in November and December 2022 when circulating variants were not neutralized by tixagevimab-cilgavimab in vitro. This suggests in vitro neutralization data correlates with clinical efficacy. DISCLOSURES: All Authors: No reported disclosures Oxford University Press 2023-11-27 /pmc/articles/PMC10678513/ http://dx.doi.org/10.1093/ofid/ofad500.1176 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
Dluzynski, Daniela
Ssentongo, Paddy
Shaheen, Shareef
Maglakelidze, Natella
Hale, Cory
Henao, Maria Paula
Chinchilli, Vernon M
Paules, Catharine I
1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies
title 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies
title_full 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies
title_fullStr 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies
title_full_unstemmed 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies
title_short 1339. Effects of Tixagevimab-Cilgavimab in Clinical Practice is Consistent with Preliminary Neutralization Studies
title_sort 1339. effects of tixagevimab-cilgavimab in clinical practice is consistent with preliminary neutralization studies
topic Abstract
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10678513/
http://dx.doi.org/10.1093/ofid/ofad500.1176
work_keys_str_mv AT dluzynskidaniela 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies
AT ssentongopaddy 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies
AT shaheenshareef 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies
AT maglakelidzenatella 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies
AT halecory 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies
AT henaomariapaula 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies
AT chinchillivernonm 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies
AT paulescatharinei 1339effectsoftixagevimabcilgavimabinclinicalpracticeisconsistentwithpreliminaryneutralizationstudies