Characteristics and treatment regimens across ERS SHARP severe asthma registries

Members of the SHARP Clinical Research Collaboration are; SHARP Clinical Research Collaboration

doi:https://doi.org/10.1183/13993003.01163-2019

Characteristics and treatment regimens across ERS SHARP severe asthma registries

Members of the SHARP Clinical Research Collaboration are, SHARP Clinical Research Collaboration

Research output: Contribution to journal › Article › Academic › peer-review

48 Citations (Scopus)

Abstract

Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m-2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day-1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day-1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.

Original language	English
Article number	1901163
Journal	European respiratory journal
Volume	55
Issue number	1
DOIs	https://doi.org/10.1183/13993003.01163-2019
Publication status	Published - 1 Jan 2020

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https://doi.org/10.1183/13993003.01163-2019

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@article{6217971fd8724f2baa3464b2ff75e5ba,

title = "Characteristics and treatment regimens across ERS SHARP severe asthma registries",

abstract = "Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m-2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day-1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day-1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.",

author = "{van Bragt}, {Job J. M. H.} and Adcock, {Ian M.} and Bel, {Elisabeth H. D.} and Gert-Jan Braunstahl and John Busby and Canonica, {Giorgio W.} and Hui Cao and Chung, {Kian Fan} and Zsuzsanna Csoma and Barbro Dahl{\'e}n and Elizabeth Davin and Susanne Hansen and Enrico Heffler and Ildiko Horvath and Stephanie Korn and Maxim Kots and Piotr Kuna and Namhee Kwon and Renaud Louis and Vicente Plaza and Celeste Porsbjerg and David Ramos-Barbon and Richards, {Levi B.} and Sabina {\v S}krgat and Sont, {Jacob K.} and Vijverberg, {Susanne J. H.} and Weersink, {Els J. M.} and Valentyna Yasinska and Wagers, {Scott S.} and Ratko Djukanovic and {Maitland-van der Zee}, {Anke H.} and {Members of the SHARP Clinical Research Collaboration are} and {SHARP Clinical Research Collaboration} and B. Abenhardt and Adcock, {I. M.} and J. Adler and R. Alfonso and R. Ali and S. Alkameh and {Almonacid S{\'a}nchez}, C. and L. Alvares and G. Anderson and K. Assing and S. Ayre and J. Becker and Bel, {E. H. D.} and K. Bergmann and K. Bieksiene and N. Bjerring and {Maitland-van der Zee}, {A. H.} and Weersink, {E. J.}",

note = "Funding Information: Conflict of interest: J.J.M.H. van Bragt has nothing to disclose. I.M. Adcock has nothing to disclose. E.H.D. Bel reports grants and personal fees from AstraZeneca, GSK and Novartis, grants from Teva, and personal fees from Boehringer Ingelheim, Sanofi/Regeneron, Vectura and Sterna, outside the submitted work. G-J. Braunstahl reports grants from GSK, Novartis, AstraZeneca and Chiesi, outside the submitted work. A. Ten Brinke reports institutional fees for research advisory boards and lectures from GSK, Teva and AstraZeneca, institutional fees for research advisory boards from Sanofi, Novartis and Boehringer Ingelheim, outside the submitted work. J. Busby has nothing to disclose. G.W. Canonica reports personal fees from A. Menarini, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, GSK, MSD, Novartis, Roche, Sanofi-Aventis and Teva, during the conduct of the study. H. Cao is an employee of Novartis, which is one of the funding pharmaceutical companies of SHARP. K.F. Chung has received honoraria for participating in advisory board meetings from GSK, AstraZeneca, Novartis, Merck, Boehringer Ingelheim and Teva regarding treatments for asthma and chronic obstructive pulmonary disease and has also been remunerated for speaking engagements. Z. Csoma has nothing to disclose. B. Dahl{\'e}n reports advisory board membership for Teva, GSK and Sanofi, personal fees for lectures from AstraZeneca, outside the submitted work. E. Davin has nothing to disclose. S. Hansen has nothing to disclose. E. Heffler reports personal fees from AstraZeneca, Sanofi Genzyme, Teva, Novartis, GSK, Circassia and Nestle Purina, outside the submitted work. I. Horvath reports personal fees from AstraZeneca, Boehringer Ingelheim, GSK, Chiesi, Berlin-Chemie, Roche, MSD, CSL and Sager Pharma, outside the submitted work. S. Korn reports personal fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Teva and Roche, grants and personal fees from GSK and Novartis, during the conduct of the study. M. Kots is a full time Chiesi Famaceutici SpA employee, Global clinical development department. P. Kuna reports personal fees for lectures and advisory board work from AstraZeneca and Novartis, personal fees for lectures and nonfinancial support for meeting attendance from Berlin-Chemie, Menarini and Boehringer Ingelheim, outside the submitted work. N. Kwon is an employee of GSK. R. Louis reports grants and personal fees for advisory board work from GSK, AstraZeneca and Novartis, grants from Chiesi, outside the submitted work. V. Plaza reports grants, personal fees and nonfinancial support from Chiesi, grants and personal fees from AstraZeneca, personal fees from ALK, Mundipharma and Sanofi, grants from Menarini, outside the submitted work. C. Porsbjerg has nothing to disclose. D. Ramos-Barbon has nothing to disclose. L.B. Richards has nothing to disclose. S. {\v S}krgat reports personal fees for lectures and scientific discussion at symposia from Teva and Boehringer, personal fees for lectures and advisory boards from AstraZeneca, Glaxo, Berlin-Chemie and Chiesi, outside the submitted work. J.K. Sont has nothing to disclose. S.J.H. Vijverberg has nothing to disclose. E.J. Weersink has nothing to disclose. V. Yasinska has nothing to disclose. S.S. Wagers reports consultancy fees from the European Respiratory Society, during the conduct of the study; consultancy fees from King{\textquoteright}s College Hospital NHS Foundation Trust, Academic Medical Research, AMC Medical Research BV, Asthma UK, Athens Medical School, Boehringer Ingelheim International GmbH, CHU de Toulouse, CIRO, DS Biologicals Ltd, {\'E}cole Polytechnique F{\'e}d{\'e}rale de Lausanne, European Respiratory Society, FISEVI, Fluidic Analytics Ltd, Fraunhofer IGB, Fraunhofer ITEM, GSK R&D Ltd, Holland and Knight, Karolinska Institutet Fakturor, KU Leuven, Longfonds, National Heart and Lung Institute, Novartis Pharma AG, Owlstone Medical Ltd, PExA AB, UCB Biopharma SPRL, UCB Biosciences GmbH, Ume{\aa} University, University Hospital Southampton NHS Foundation Trust, Universit{\`a} Campus Bio-Medico di Roma, Universita Cattolica Del Sacro Cuore, Universit{\"a}t Ulm, University of Bern, University of Edinburgh, University of Hull, University of Leicester, University of Loughborough, University of Luxembourg, University of Manchester, University of Nottingham, Vlaams Brabant, Dienst Europa, Imperial College London, Boehringer Ingelheim, Breathomix, Gossamer Bio, AstraZeneca and CIBER, outside the submitted work. R. Djukanovic reports receiving fees for lectures at symposia organised by Novartis, AstraZeneca and Teva, consultation for Teva and Novartis as member of advisory boards, and participation in a scientific discussion about asthma organised by GSK; and is a co-founder and current consultant, and has shares in Synairgen, a University of Southampton spin out company. A.H. Maitland-van der Zee reports personal fees for participating in an advisory board from AstraZeneca and Boehringer Ingelheim, unrestricted research grants from Boehringer Ingelheim and GSK. Publisher Copyright: Copyright {\textcopyright} ERS 2020 Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",

year = "2020",

month = jan,

day = "1",

doi = "https://doi.org/10.1183/13993003.01163-2019",

language = "English",

volume = "55",

journal = "European respiratory journal",

issn = "0903-1936",

publisher = "European Respiratory Society",

number = "1",

}

TY - JOUR

T1 - Characteristics and treatment regimens across ERS SHARP severe asthma registries

AU - van Bragt, Job J. M. H.

AU - Adcock, Ian M.

AU - Bel, Elisabeth H. D.

AU - Braunstahl, Gert-Jan

AU - Busby, John

AU - Canonica, Giorgio W.

AU - Cao, Hui

AU - Chung, Kian Fan

AU - Csoma, Zsuzsanna

AU - Dahlén, Barbro

AU - Davin, Elizabeth

AU - Hansen, Susanne

AU - Heffler, Enrico

AU - Horvath, Ildiko

AU - Korn, Stephanie

AU - Kots, Maxim

AU - Kuna, Piotr

AU - Kwon, Namhee

AU - Louis, Renaud

AU - Plaza, Vicente

AU - Porsbjerg, Celeste

AU - Ramos-Barbon, David

AU - Richards, Levi B.

AU - Škrgat, Sabina

AU - Sont, Jacob K.

AU - Vijverberg, Susanne J. H.

AU - Weersink, Els J. M.

AU - Yasinska, Valentyna

AU - Wagers, Scott S.

AU - Djukanovic, Ratko

AU - Maitland-van der Zee, Anke H.

AU - Members of the SHARP Clinical Research Collaboration are

AU - SHARP Clinical Research Collaboration

AU - Abenhardt, B.

AU - Adcock, I. M.

AU - Adler, J.

AU - Alfonso, R.

AU - Ali, R.

AU - Alkameh, S.

AU - Almonacid Sánchez, C.

AU - Alvares, L.

AU - Anderson, G.

AU - Assing, K.

AU - Ayre, S.

AU - Becker, J.

AU - Bel, E. H. D.

AU - Bergmann, K.

AU - Bieksiene, K.

AU - Bjerring, N.

AU - Maitland-van der Zee, A. H.

AU - Weersink, E. J.

N1 - Funding Information: Conflict of interest: J.J.M.H. van Bragt has nothing to disclose. I.M. Adcock has nothing to disclose. E.H.D. Bel reports grants and personal fees from AstraZeneca, GSK and Novartis, grants from Teva, and personal fees from Boehringer Ingelheim, Sanofi/Regeneron, Vectura and Sterna, outside the submitted work. G-J. Braunstahl reports grants from GSK, Novartis, AstraZeneca and Chiesi, outside the submitted work. A. Ten Brinke reports institutional fees for research advisory boards and lectures from GSK, Teva and AstraZeneca, institutional fees for research advisory boards from Sanofi, Novartis and Boehringer Ingelheim, outside the submitted work. J. Busby has nothing to disclose. G.W. Canonica reports personal fees from A. Menarini, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia, GSK, MSD, Novartis, Roche, Sanofi-Aventis and Teva, during the conduct of the study. H. Cao is an employee of Novartis, which is one of the funding pharmaceutical companies of SHARP. K.F. Chung has received honoraria for participating in advisory board meetings from GSK, AstraZeneca, Novartis, Merck, Boehringer Ingelheim and Teva regarding treatments for asthma and chronic obstructive pulmonary disease and has also been remunerated for speaking engagements. Z. Csoma has nothing to disclose. B. Dahlén reports advisory board membership for Teva, GSK and Sanofi, personal fees for lectures from AstraZeneca, outside the submitted work. E. Davin has nothing to disclose. S. Hansen has nothing to disclose. E. Heffler reports personal fees from AstraZeneca, Sanofi Genzyme, Teva, Novartis, GSK, Circassia and Nestle Purina, outside the submitted work. I. Horvath reports personal fees from AstraZeneca, Boehringer Ingelheim, GSK, Chiesi, Berlin-Chemie, Roche, MSD, CSL and Sager Pharma, outside the submitted work. S. Korn reports personal fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Teva and Roche, grants and personal fees from GSK and Novartis, during the conduct of the study. M. Kots is a full time Chiesi Famaceutici SpA employee, Global clinical development department. P. Kuna reports personal fees for lectures and advisory board work from AstraZeneca and Novartis, personal fees for lectures and nonfinancial support for meeting attendance from Berlin-Chemie, Menarini and Boehringer Ingelheim, outside the submitted work. N. Kwon is an employee of GSK. R. Louis reports grants and personal fees for advisory board work from GSK, AstraZeneca and Novartis, grants from Chiesi, outside the submitted work. V. Plaza reports grants, personal fees and nonfinancial support from Chiesi, grants and personal fees from AstraZeneca, personal fees from ALK, Mundipharma and Sanofi, grants from Menarini, outside the submitted work. C. Porsbjerg has nothing to disclose. D. Ramos-Barbon has nothing to disclose. L.B. Richards has nothing to disclose. S. Škrgat reports personal fees for lectures and scientific discussion at symposia from Teva and Boehringer, personal fees for lectures and advisory boards from AstraZeneca, Glaxo, Berlin-Chemie and Chiesi, outside the submitted work. J.K. Sont has nothing to disclose. S.J.H. Vijverberg has nothing to disclose. E.J. Weersink has nothing to disclose. V. Yasinska has nothing to disclose. S.S. Wagers reports consultancy fees from the European Respiratory Society, during the conduct of the study; consultancy fees from King’s College Hospital NHS Foundation Trust, Academic Medical Research, AMC Medical Research BV, Asthma UK, Athens Medical School, Boehringer Ingelheim International GmbH, CHU de Toulouse, CIRO, DS Biologicals Ltd, École Polytechnique Fédérale de Lausanne, European Respiratory Society, FISEVI, Fluidic Analytics Ltd, Fraunhofer IGB, Fraunhofer ITEM, GSK R&D Ltd, Holland and Knight, Karolinska Institutet Fakturor, KU Leuven, Longfonds, National Heart and Lung Institute, Novartis Pharma AG, Owlstone Medical Ltd, PExA AB, UCB Biopharma SPRL, UCB Biosciences GmbH, Umeå University, University Hospital Southampton NHS Foundation Trust, Università Campus Bio-Medico di Roma, Universita Cattolica Del Sacro Cuore, Universität Ulm, University of Bern, University of Edinburgh, University of Hull, University of Leicester, University of Loughborough, University of Luxembourg, University of Manchester, University of Nottingham, Vlaams Brabant, Dienst Europa, Imperial College London, Boehringer Ingelheim, Breathomix, Gossamer Bio, AstraZeneca and CIBER, outside the submitted work. R. Djukanovic reports receiving fees for lectures at symposia organised by Novartis, AstraZeneca and Teva, consultation for Teva and Novartis as member of advisory boards, and participation in a scientific discussion about asthma organised by GSK; and is a co-founder and current consultant, and has shares in Synairgen, a University of Southampton spin out company. A.H. Maitland-van der Zee reports personal fees for participating in an advisory board from AstraZeneca and Boehringer Ingelheim, unrestricted research grants from Boehringer Ingelheim and GSK. Publisher Copyright: Copyright © ERS 2020 Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

PY - 2020/1/1

Y1 - 2020/1/1

N2 - Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m-2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day-1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day-1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.

AB - Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many differences in characteristics and lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium), mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m-2 (the UK) and the largest difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was 20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335 µg·day-1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5 antibody and from 772 to 1344 µg·day-1 in those starting anti-IgE (Slovenia versus Spain). Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE, respectively.The severe asthmatic population in Europe is heterogeneous and differs in both clinical characteristics and treatment, often appearing not to comply with the current European Respiratory Society/American Thoracic Society guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.

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U2 - https://doi.org/10.1183/13993003.01163-2019

DO - https://doi.org/10.1183/13993003.01163-2019

M3 - Article

C2 - 31601713

SN - 0903-1936

VL - 55

JO - European respiratory journal

JF - European respiratory journal

IS - 1

M1 - 1901163

ER -

Characteristics and treatment regimens across ERS SHARP severe asthma registries

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