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Characteristics of severe asthma patients on biologics: a real-life European registry study

BACKGROUND: The use of anti-interleukin-5 (IL5) for severe asthma is based on criteria from randomised controlled trials (RCTs), but in real-life patients might not fulfil the eligibility criteria but may benefit from biologics. We aimed to characterise patients starting anti-IL5(R) in Europe and ev...

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Autores principales: Principe, Stefania, Richards, Levi B., Hashimoto, Simone, Kroes, Johannes Anthon, Van Bragt, Job J.M.H., Vijverberg, Susanne J., Sont, Jacob K., Scichilone, Nicola, Bieksiene, Kristina, Ten Brinke, Anneke, Csoma, Zsuzsanna, Dahlén, Barbro, Gemicioglu, Bilun, Grisle, Ineta, Kuna, Piotr, Lazic, Zorica, Mihaltan, Florin, Popović-Grle, Sanja, Škrgat, Sabina, Marcon, Alessandro, Caminati, Marco, Djukanovic, Ratko, Porsbjerg, Celeste, Maitland Van Der Zee, Anke-Hilse
Formato: Online Artículo Texto
Lenguaje:English
Publicado: European Respiratory Society 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10152256/
https://www.ncbi.nlm.nih.gov/pubmed/37143845
http://dx.doi.org/10.1183/23120541.00586-2022
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author Principe, Stefania
Richards, Levi B.
Hashimoto, Simone
Kroes, Johannes Anthon
Van Bragt, Job J.M.H.
Vijverberg, Susanne J.
Sont, Jacob K.
Scichilone, Nicola
Bieksiene, Kristina
Ten Brinke, Anneke
Csoma, Zsuzsanna
Dahlén, Barbro
Gemicioglu, Bilun
Grisle, Ineta
Kuna, Piotr
Lazic, Zorica
Mihaltan, Florin
Popović-Grle, Sanja
Škrgat, Sabina
Marcon, Alessandro
Caminati, Marco
Djukanovic, Ratko
Porsbjerg, Celeste
Maitland Van Der Zee, Anke-Hilse
author_facet Principe, Stefania
Richards, Levi B.
Hashimoto, Simone
Kroes, Johannes Anthon
Van Bragt, Job J.M.H.
Vijverberg, Susanne J.
Sont, Jacob K.
Scichilone, Nicola
Bieksiene, Kristina
Ten Brinke, Anneke
Csoma, Zsuzsanna
Dahlén, Barbro
Gemicioglu, Bilun
Grisle, Ineta
Kuna, Piotr
Lazic, Zorica
Mihaltan, Florin
Popović-Grle, Sanja
Škrgat, Sabina
Marcon, Alessandro
Caminati, Marco
Djukanovic, Ratko
Porsbjerg, Celeste
Maitland Van Der Zee, Anke-Hilse
author_sort Principe, Stefania
collection PubMed
description BACKGROUND: The use of anti-interleukin-5 (IL5) for severe asthma is based on criteria from randomised controlled trials (RCTs), but in real-life patients might not fulfil the eligibility criteria but may benefit from biologics. We aimed to characterise patients starting anti-IL5(R) in Europe and evaluate the discrepancies between initiation of anti-IL5(R) in real life and in RCTs. MATERIALS AND METHODS: We performed a cross-sectional analysis with data from the severe asthma patients at the start of anti-IL5(R) in the Severe Heterogeneous Asthma Research collaboration Patient-centred (SHARP Central) registry. We compared the baseline characteristics of the patients starting anti-IL5(R) from 11 European countries within SHARP with the baseline characteristics of the severe asthma patients from 10 RCTs (four for mepolizumab, three for benralizumab and three for reslizumab). Patients were evaluated following eligibility criteria from the RCTs of anti-IL5 therapies. RESULTS: Patients starting anti-IL5(R) in Europe (n=1231) differed in terms of smoking history, clinical characteristics and medication use. The characteristics of severe asthma patients in the SHARP registry differed from the characteristics of patients in RCTs. Only 327 (26.56%) patients fulfilled eligibility criteria of all the RCTs; 24 patients were eligible for mepolizumab, 100 for benralizumab and 52 reslizumab. The main characteristics of ineligibility were: ≥10 pack-years, respiratory diseases other than asthma, Asthma Control Questionnaire score ≤1.5 and low-dose inhaled corticosteroids. CONCLUSION: A large proportion of patients in the SHARP registry would not have been eligible for anti-IL5(R) treatment in RCTs, demonstrating the importance of real-life cohorts in describing the efficacy of biologics in a broader population of patients with severe asthma.
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spelling pubmed-101522562023-05-03 Characteristics of severe asthma patients on biologics: a real-life European registry study Principe, Stefania Richards, Levi B. Hashimoto, Simone Kroes, Johannes Anthon Van Bragt, Job J.M.H. Vijverberg, Susanne J. Sont, Jacob K. Scichilone, Nicola Bieksiene, Kristina Ten Brinke, Anneke Csoma, Zsuzsanna Dahlén, Barbro Gemicioglu, Bilun Grisle, Ineta Kuna, Piotr Lazic, Zorica Mihaltan, Florin Popović-Grle, Sanja Škrgat, Sabina Marcon, Alessandro Caminati, Marco Djukanovic, Ratko Porsbjerg, Celeste Maitland Van Der Zee, Anke-Hilse ERJ Open Res Original Research Articles BACKGROUND: The use of anti-interleukin-5 (IL5) for severe asthma is based on criteria from randomised controlled trials (RCTs), but in real-life patients might not fulfil the eligibility criteria but may benefit from biologics. We aimed to characterise patients starting anti-IL5(R) in Europe and evaluate the discrepancies between initiation of anti-IL5(R) in real life and in RCTs. MATERIALS AND METHODS: We performed a cross-sectional analysis with data from the severe asthma patients at the start of anti-IL5(R) in the Severe Heterogeneous Asthma Research collaboration Patient-centred (SHARP Central) registry. We compared the baseline characteristics of the patients starting anti-IL5(R) from 11 European countries within SHARP with the baseline characteristics of the severe asthma patients from 10 RCTs (four for mepolizumab, three for benralizumab and three for reslizumab). Patients were evaluated following eligibility criteria from the RCTs of anti-IL5 therapies. RESULTS: Patients starting anti-IL5(R) in Europe (n=1231) differed in terms of smoking history, clinical characteristics and medication use. The characteristics of severe asthma patients in the SHARP registry differed from the characteristics of patients in RCTs. Only 327 (26.56%) patients fulfilled eligibility criteria of all the RCTs; 24 patients were eligible for mepolizumab, 100 for benralizumab and 52 reslizumab. The main characteristics of ineligibility were: ≥10 pack-years, respiratory diseases other than asthma, Asthma Control Questionnaire score ≤1.5 and low-dose inhaled corticosteroids. CONCLUSION: A large proportion of patients in the SHARP registry would not have been eligible for anti-IL5(R) treatment in RCTs, demonstrating the importance of real-life cohorts in describing the efficacy of biologics in a broader population of patients with severe asthma. European Respiratory Society 2023-05-02 /pmc/articles/PMC10152256/ /pubmed/37143845 http://dx.doi.org/10.1183/23120541.00586-2022 Text en Copyright ©The authors 2023 https://creativecommons.org/licenses/by-nc/4.0/This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions@ersnet.org (mailto:permissions@ersnet.org)
spellingShingle Original Research Articles
Principe, Stefania
Richards, Levi B.
Hashimoto, Simone
Kroes, Johannes Anthon
Van Bragt, Job J.M.H.
Vijverberg, Susanne J.
Sont, Jacob K.
Scichilone, Nicola
Bieksiene, Kristina
Ten Brinke, Anneke
Csoma, Zsuzsanna
Dahlén, Barbro
Gemicioglu, Bilun
Grisle, Ineta
Kuna, Piotr
Lazic, Zorica
Mihaltan, Florin
Popović-Grle, Sanja
Škrgat, Sabina
Marcon, Alessandro
Caminati, Marco
Djukanovic, Ratko
Porsbjerg, Celeste
Maitland Van Der Zee, Anke-Hilse
Characteristics of severe asthma patients on biologics: a real-life European registry study
title Characteristics of severe asthma patients on biologics: a real-life European registry study
title_full Characteristics of severe asthma patients on biologics: a real-life European registry study
title_fullStr Characteristics of severe asthma patients on biologics: a real-life European registry study
title_full_unstemmed Characteristics of severe asthma patients on biologics: a real-life European registry study
title_short Characteristics of severe asthma patients on biologics: a real-life European registry study
title_sort characteristics of severe asthma patients on biologics: a real-life european registry study
topic Original Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10152256/
https://www.ncbi.nlm.nih.gov/pubmed/37143845
http://dx.doi.org/10.1183/23120541.00586-2022
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