Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study

Anne Noelle Frix; Liam G. Heaney; Barbro Dahlén; Florin Mihaltan; Svetlana Sergejeva; Sanja Popović-Grle; Vratislav Sedlak; Lauri Lehtimäki; Arnaud Bourdin; Stephanie Korn; Eleftherios Zervas; Zsuzsanna Csoma; Dora Lúðvíksdóttir; Marcus Butler; Giorgio Walter Canonica; Ineta Grisle; Kristina Bieksiene; Anneke Ten Brinke; Piotr Kuna; Claudia Chaves Loureiro; Natalia M. Nenasheva; Zorica Lazic; Sabina Škrgat; David Ramos-Barbon; Joerg Leuppi; Bilun Gemicioglu; Apostolos Bossios; Celeste M. Porsbjerg; Elisabeth H. Bel; Ratko Djukanovic; Renaud Louis

doi:10.1183/23120541.00273-2022

Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study

Anne Noelle Frix, Liam G. Heaney, Barbro Dahlén, Florin Mihaltan, Svetlana Sergejeva, Sanja Popović-Grle, Vratislav Sedlak, Lauri Lehtimäki, Arnaud Bourdin, Stephanie Korn, Eleftherios Zervas, Zsuzsanna Csoma, Dora Lúðvíksdóttir, Marcus Butler, Giorgio Walter Canonica, Ineta Grisle, Kristina Bieksiene, Anneke Ten Brinke, Piotr Kuna, Claudia Chaves LoureiroNatalia M. Nenasheva, Zorica Lazic, Sabina Škrgat, David Ramos-Barbon, Joerg Leuppi, Bilun Gemicioglu, Apostolos Bossios, Celeste M. Porsbjerg, Elisabeth H. Bel, Ratko Djukanovic, Renaud Louis

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Abstract

Introduction Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown. Materials and methods The European Respiratory Society (ERS) SHARP Clinical Research Collaboration conducted a three-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on seven end-points: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies. Results Availability of biologics varied between countries, with 17 out of 28 countries having all five existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, forced expiratory volume in 1 s was used in 46%. Blood eosinophils were an inclusion criterion in all countries for interleukin-5 (IL-5)-targeted and IL-4/IL-13-targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73% (191 out of 263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity. Conclusion Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation.

Original language	English
Article number	00273-2022
Number of pages	13
Journal	ERJ Open Research
Volume	8
Issue number	4
DOIs	https://doi.org/10.1183/23120541.00273-2022
Publication status	Published - 2022
Publication type	A1 Journal article-refereed

Funding

The SHARP National Leads survey revealed that corticosteroid-induced toxicity was assessed in 20 countries (mainly by clinical evaluation and cortisol blood levels). This was supported by data extracted from the Experts Broad Survey, which showed evaluation by 70% of experts. Cortisol blood level and clinical evaluation were also the most commonly used assessment modalities. Support statement: The SHARP CRC has been supported by financial and other contributions from the following consortium partners: European Respiratory Society, GlaxoSmithKline Research and Development Limited, Chiesi Farmaceutici SPA, Novartis Pharma AG, Sanofi-Genzyme Corporation, and Teva Branded Pharmaceutical Products R&D, Inc. Funding information for this article has been deposited with the Crossref Funder Registry.

Publication forum classification

Publication forum level 1

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

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10.1183/23120541.00273-2022Licence: CC BY-NC

00273-2022.fullFinal published version, 714 KBLicence: CC BY-NC

https://urn.fi/URN:NBN:fi:tuni-202212099012Licence: CC BY-NC

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Frix, A. N., Heaney, L. G., Dahlén, B., Mihaltan, F., Sergejeva, S., Popović-Grle, S., Sedlak, V., Lehtimäki, L., Bourdin, A., Korn, S., Zervas, E., Csoma, Z., Lúðvíksdóttir, D., Butler, M., Canonica, G. W., Grisle, I., Bieksiene, K., Ten Brinke, A., Kuna, P., ... Louis, R. (2022). Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study. ERJ Open Research, 8(4), Article 00273-2022. https://doi.org/10.1183/23120541.00273-2022

@article{17c07f990ae54cdb8eb77b11caffd48e,

title = "Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study",

abstract = "Introduction Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown. Materials and methods The European Respiratory Society (ERS) SHARP Clinical Research Collaboration conducted a three-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on seven end-points: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies. Results Availability of biologics varied between countries, with 17 out of 28 countries having all five existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, forced expiratory volume in 1 s was used in 46%. Blood eosinophils were an inclusion criterion in all countries for interleukin-5 (IL-5)-targeted and IL-4/IL-13-targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73% (191 out of 263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity. Conclusion Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation.",

author = "Frix, {Anne Noelle} and Heaney, {Liam G.} and Barbro Dahl{\'e}n and Florin Mihaltan and Svetlana Sergejeva and Sanja Popovi{\'c}-Grle and Vratislav Sedlak and Lauri Lehtim{\"a}ki and Arnaud Bourdin and Stephanie Korn and Eleftherios Zervas and Zsuzsanna Csoma and Dora L{\'u}{\dh}v{\'i}ksd{\'o}ttir and Marcus Butler and Canonica, {Giorgio Walter} and Ineta Grisle and Kristina Bieksiene and {Ten Brinke}, Anneke and Piotr Kuna and Loureiro, {Claudia Chaves} and Nenasheva, {Natalia M.} and Zorica Lazic and Sabina {\v S}krgat and David Ramos-Barbon and Joerg Leuppi and Bilun Gemicioglu and Apostolos Bossios and Porsbjerg, {Celeste M.} and Bel, {Elisabeth H.} and Ratko Djukanovic and Renaud Louis",

note = "Funding Information: The SHARP National Leads survey revealed that corticosteroid-induced toxicity was assessed in 20 countries (mainly by clinical evaluation and cortisol blood levels). This was supported by data extracted from the Experts Broad Survey, which showed evaluation by 70% of experts. Cortisol blood level and clinical evaluation were also the most commonly used assessment modalities. Funding Information: Support statement: The SHARP CRC has been supported by financial and other contributions from the following consortium partners: European Respiratory Society, GlaxoSmithKline Research and Development Limited, Chiesi Farmaceutici SPA, Novartis Pharma AG, Sanofi-Genzyme Corporation, and Teva Branded Pharmaceutical Products R&D, Inc. Funding information for this article has been deposited with the Crossref Funder Registry. Publisher Copyright: {\textcopyright} The authors 2022.",

year = "2022",

doi = "10.1183/23120541.00273-2022",

language = "English",

volume = "8",

journal = "ERJ Open Research",

issn = "2312-0541",

publisher = "European Respiratory Society",

number = "4",

}

Frix, AN, Heaney, LG, Dahlén, B, Mihaltan, F, Sergejeva, S, Popović-Grle, S, Sedlak, V, Lehtimäki, L, Bourdin, A, Korn, S, Zervas, E, Csoma, Z, Lúðvíksdóttir, D, Butler, M, Canonica, GW, Grisle, I, Bieksiene, K, Ten Brinke, A, Kuna, P, Loureiro, CC, Nenasheva, NM, Lazic, Z, Škrgat, S, Ramos-Barbon, D, Leuppi, J, Gemicioglu, B, Bossios, A, Porsbjerg, CM, Bel, EH, Djukanovic, R & Louis, R 2022, 'Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study', ERJ Open Research, vol. 8, no. 4, 00273-2022. https://doi.org/10.1183/23120541.00273-2022

TY - JOUR

T1 - Heterogeneity in the use of biologics for severe asthma in Europe

T2 - a SHARP ERS study

AU - Frix, Anne Noelle

AU - Heaney, Liam G.

AU - Dahlén, Barbro

AU - Mihaltan, Florin

AU - Sergejeva, Svetlana

AU - Popović-Grle, Sanja

AU - Sedlak, Vratislav

AU - Lehtimäki, Lauri

AU - Bourdin, Arnaud

AU - Korn, Stephanie

AU - Zervas, Eleftherios

AU - Csoma, Zsuzsanna

AU - Lúðvíksdóttir, Dora

AU - Butler, Marcus

AU - Canonica, Giorgio Walter

AU - Grisle, Ineta

AU - Bieksiene, Kristina

AU - Ten Brinke, Anneke

AU - Kuna, Piotr

AU - Loureiro, Claudia Chaves

AU - Nenasheva, Natalia M.

AU - Lazic, Zorica

AU - Škrgat, Sabina

AU - Ramos-Barbon, David

AU - Leuppi, Joerg

AU - Gemicioglu, Bilun

AU - Bossios, Apostolos

AU - Porsbjerg, Celeste M.

AU - Bel, Elisabeth H.

AU - Djukanovic, Ratko

AU - Louis, Renaud

N1 - Funding Information: The SHARP National Leads survey revealed that corticosteroid-induced toxicity was assessed in 20 countries (mainly by clinical evaluation and cortisol blood levels). This was supported by data extracted from the Experts Broad Survey, which showed evaluation by 70% of experts. Cortisol blood level and clinical evaluation were also the most commonly used assessment modalities. Funding Information: Support statement: The SHARP CRC has been supported by financial and other contributions from the following consortium partners: European Respiratory Society, GlaxoSmithKline Research and Development Limited, Chiesi Farmaceutici SPA, Novartis Pharma AG, Sanofi-Genzyme Corporation, and Teva Branded Pharmaceutical Products R&D, Inc. Funding information for this article has been deposited with the Crossref Funder Registry. Publisher Copyright: © The authors 2022.

PY - 2022

Y1 - 2022

N2 - Introduction Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown. Materials and methods The European Respiratory Society (ERS) SHARP Clinical Research Collaboration conducted a three-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on seven end-points: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies. Results Availability of biologics varied between countries, with 17 out of 28 countries having all five existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, forced expiratory volume in 1 s was used in 46%. Blood eosinophils were an inclusion criterion in all countries for interleukin-5 (IL-5)-targeted and IL-4/IL-13-targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73% (191 out of 263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity. Conclusion Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation.

AB - Introduction Treatment with biologics for severe asthma is informed by international and national guidelines and defined by national regulating bodies, but how these drugs are used in real-life is unknown. Materials and methods The European Respiratory Society (ERS) SHARP Clinical Research Collaboration conducted a three-step survey collecting information on asthma biologics use in Europe. Five geographically distant countries defined the survey questions, focusing on seven end-points: biologics availability and financial issues, prescription and administration modalities, inclusion criteria, continuation criteria, switching biologics, combining biologics and evaluation of corticosteroid toxicity. The survey was then sent to SHARP National Leads of 28 European countries. Finally, selected questions were submitted to a broad group of 263 asthma experts identified by national societies. Results Availability of biologics varied between countries, with 17 out of 28 countries having all five existing biologics. Authorised prescribers (pulmonologists and other specialists) also differed. In-hospital administration was the preferred deliverance modality. While exacerbation rate was used as an inclusion criterion in all countries, forced expiratory volume in 1 s was used in 46%. Blood eosinophils were an inclusion criterion in all countries for interleukin-5 (IL-5)-targeted and IL-4/IL-13-targeted biologics, with varying thresholds. There were no formally established criteria for continuing biologics. Reduction in exacerbations represented the most important benchmark, followed by improvement in asthma control and quality of life. Only 73% (191 out of 263) of surveyed clinicians assessed their patients for corticosteroid-induced toxicity. Conclusion Our study reveals important heterogeneity in the use of asthma biologics across Europe. To what extent this impacts on clinical outcomes relevant to patients and healthcare services needs further investigation.

U2 - 10.1183/23120541.00273-2022

DO - 10.1183/23120541.00273-2022

M3 - Article

AN - SCOPUS:85140483184

SN - 2312-0541

VL - 8

JO - ERJ Open Research

JF - ERJ Open Research

IS - 4

M1 - 00273-2022

ER -

Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study

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