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The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study

INTRODUCTION: Omalizumab was proven to be effective and safe in patients with moderate-to-severe allergic asthma. However, there is no direct evidence of the benefits of add-on omalizumab in real-life practice in the Slovakian population. AIM: This subgroup analysis assessed the real-life effectiven...

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Autores principales: Siracká, Simona, Tinková, Lenka Dzivá, Hochmuth, Luděk, Leščišinová, Helena, Hrubiško, Martin, Dostálová, Katarína, Jeseňák, Miloš
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Termedia Publishing House 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9993205/
https://www.ncbi.nlm.nih.gov/pubmed/36909923
http://dx.doi.org/10.5114/ada.2022.116532
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author Siracká, Simona
Tinková, Lenka Dzivá
Hochmuth, Luděk
Leščišinová, Helena
Hrubiško, Martin
Dostálová, Katarína
Jeseňák, Miloš
author_facet Siracká, Simona
Tinková, Lenka Dzivá
Hochmuth, Luděk
Leščišinová, Helena
Hrubiško, Martin
Dostálová, Katarína
Jeseňák, Miloš
author_sort Siracká, Simona
collection PubMed
description INTRODUCTION: Omalizumab was proven to be effective and safe in patients with moderate-to-severe allergic asthma. However, there is no direct evidence of the benefits of add-on omalizumab in real-life practice in the Slovakian population. AIM: This subgroup analysis assessed the real-life effectiveness and safety of omalizumab in Slovakian patients with severe allergic asthma enrolled in the eXpeRience registry. MATERIAL AND METHODS: Patients who commenced omalizumab 15 weeks prior to inclusion were assessed for the physicians’ global evaluation of treatment effectiveness (GETE), exacerbation rate, asthma symptoms, lung function, oral corticosteroid (OCS) use, rescue medication, hospitalizations, and school/work absenteeism at 16 weeks and 12 and 24 months. RESULTS: Of 204 patients, 159 (77.9%) completed 2-year follow-up. As per GETE, 69.5% of patients treated with omalizumab achieved excellent/good response at 16 (±1) weeks. The proportion of patients with no severe clinically significant asthma exacerbations increased from 17.3% at pre-treatment to 82.4% and 92.0% at months 12 and 24, respectively. Maintenance OCS use was reduced to 17.0% and 15.3% of patients at 12 and 24 months, respectively, compared with 34.7% at baseline (BL). From BL until month 24, asthma control test scores improved from 11.6 to 20.3; rescue medication use/week decreased from 5.5 to 1.6 days; mean total number of days of asthma-related medical healthcare use decreased from 7.7 to 0.3 days and missed workdays decreased from 16.8 to 0.3 days. No new safety signals were observed. CONCLUSIONS: Add-on omalizumab was effective and well-tolerated in Slovakian patients, complementing the results observed in the overall population of eXpeRience.
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spelling pubmed-99932052023-03-09 The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study Siracká, Simona Tinková, Lenka Dzivá Hochmuth, Luděk Leščišinová, Helena Hrubiško, Martin Dostálová, Katarína Jeseňák, Miloš Postepy Dermatol Alergol Original Paper INTRODUCTION: Omalizumab was proven to be effective and safe in patients with moderate-to-severe allergic asthma. However, there is no direct evidence of the benefits of add-on omalizumab in real-life practice in the Slovakian population. AIM: This subgroup analysis assessed the real-life effectiveness and safety of omalizumab in Slovakian patients with severe allergic asthma enrolled in the eXpeRience registry. MATERIAL AND METHODS: Patients who commenced omalizumab 15 weeks prior to inclusion were assessed for the physicians’ global evaluation of treatment effectiveness (GETE), exacerbation rate, asthma symptoms, lung function, oral corticosteroid (OCS) use, rescue medication, hospitalizations, and school/work absenteeism at 16 weeks and 12 and 24 months. RESULTS: Of 204 patients, 159 (77.9%) completed 2-year follow-up. As per GETE, 69.5% of patients treated with omalizumab achieved excellent/good response at 16 (±1) weeks. The proportion of patients with no severe clinically significant asthma exacerbations increased from 17.3% at pre-treatment to 82.4% and 92.0% at months 12 and 24, respectively. Maintenance OCS use was reduced to 17.0% and 15.3% of patients at 12 and 24 months, respectively, compared with 34.7% at baseline (BL). From BL until month 24, asthma control test scores improved from 11.6 to 20.3; rescue medication use/week decreased from 5.5 to 1.6 days; mean total number of days of asthma-related medical healthcare use decreased from 7.7 to 0.3 days and missed workdays decreased from 16.8 to 0.3 days. No new safety signals were observed. CONCLUSIONS: Add-on omalizumab was effective and well-tolerated in Slovakian patients, complementing the results observed in the overall population of eXpeRience. Termedia Publishing House 2022-06-01 2023-02 /pmc/articles/PMC9993205/ /pubmed/36909923 http://dx.doi.org/10.5114/ada.2022.116532 Text en Copyright: © 2023 Termedia Sp. z o. o. https://creativecommons.org/licenses/by-nc-sa/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
spellingShingle Original Paper
Siracká, Simona
Tinková, Lenka Dzivá
Hochmuth, Luděk
Leščišinová, Helena
Hrubiško, Martin
Dostálová, Katarína
Jeseňák, Miloš
The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study
title The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study
title_full The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study
title_fullStr The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study
title_full_unstemmed The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study
title_short The “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study
title_sort “real-world” effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in slovakia: a subgroup analysis of the experience study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9993205/
https://www.ncbi.nlm.nih.gov/pubmed/36909923
http://dx.doi.org/10.5114/ada.2022.116532
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