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Characteristics and treatment regimens across ERS SHARP severe asthma registries

Job J.M.H. van Bragt, Ian M. Adcock, Elisabeth H.D. Bel, Gert-Jan Braunstahl, Anneke Ten Brinke, John Busby, Giorgio W. Canonica, Hui Cao, Kian Fan Chung, Zsuzsanna Csoma, Barbro Dahlen, Elizabeth Davin, Susanne Hansen, Enrico Heffler, Ildiko Horvath, Stephanie Korn, Maxim Kots, Piotr Kuna, Namhee Kwon, Renaud Louis, Vicente Plaza, Celeste Porsbjerg, David Ramos-Barbon, Levi B. Richards, Sabina Skrgat, Jacob K. Sont, Susanne J.H. Vijverberg, Els J. Weersink, Valentyna Yasinska, Scott S. Wagers, Ratko Djukanovic, Anke H. Maitland-van der Zee on behalf of the SHARP CRC
European Respiratory Journal 2019; DOI: 10.1183/13993003.01163-2019
Job J.M.H. van Bragt
1Amsterdam UMC, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands
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  • ORCID record for Job J.M.H. van Bragt
  • For correspondence: j.j.vanbragt@amsterdamumc.nl
Ian M. Adcock
2National Heart and Lung Institute, Imperial College London, London, United Kingdom
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Elisabeth H.D. Bel
1Amsterdam UMC, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands
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Gert-Jan Braunstahl
3Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands
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Anneke Ten Brinke
4Medical Centre Leeuwarden, Leeuwarden, The Netherlands
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John Busby
5Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, United Kingdom
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Giorgio W. Canonica
6Personalized Medicine Clinic, Asthma and Allergy, Humanitas Clinical and Research Center, Humanitas University, Rozzano and SANI-Severe Asthma Network Italy, Milan, Italy
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Hui Cao
7Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
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Kian Fan Chung
8Airway Disease, National Heart and Lung Institute, Imperial College London, London, United Kingdom
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Zsuzsanna Csoma
9National Koranyi Institute of Pulmonology, Budapest, Hungary
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Barbro Dahlen
10Division of Respiratory Medicine and Allergy, Department of Medicine, Karolinska University Hospital, Huddinge, Sweden
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Elizabeth Davin
11European Lung Foundation, Sheffield, United Kingdom
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Susanne Hansen
12Center for Clinical Research and Disease Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen, The Capital Region, Denmark
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Enrico Heffler
6Personalized Medicine Clinic, Asthma and Allergy, Humanitas Clinical and Research Center, Humanitas University, Rozzano and SANI-Severe Asthma Network Italy, Milan, Italy
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Ildiko Horvath
9National Koranyi Institute of Pulmonology, Budapest, Hungary
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Stephanie Korn
13Universitätsmedizin Mainz, Mainz, Germany
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Maxim Kots
14Chiesi Farmaceutici, Global Clinical Development, Parma, Italy
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Piotr Kuna
15Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland
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Namhee Kwon
16Respiratory Medical Franchise, GSK, Brentford, United Kingdom
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Renaud Louis
17Department of Pulmonary Medicine, Centre Hospitalier Universitaire (CHU), GIGAI3 Research Group, Liege University, Liege, Belgium
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Vicente Plaza
18Respiratory Medicine Department & Biomedical Research Institute, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
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Celeste Porsbjerg
19Respiratory Research Unit, Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark
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David Ramos-Barbon
18Respiratory Medicine Department & Biomedical Research Institute, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain
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Levi B. Richards
1Amsterdam UMC, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands
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Sabina Skrgat
20University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia
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Jacob K. Sont
21Department of Biomedical Data Sciences, section Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands
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Susanne J.H. Vijverberg
1Amsterdam UMC, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands
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Els J. Weersink
1Amsterdam UMC, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands
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Valentyna Yasinska
10Division of Respiratory Medicine and Allergy, Department of Medicine, Karolinska University Hospital, Huddinge, Sweden
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Scott S. Wagers
22BioSciConsulting, Maasmechelen, Belgium
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Ratko Djukanovic
23NIHR Southampton Respiratory Biomedical Research Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom
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Anke H. Maitland-van der Zee
1Amsterdam UMC, University of Amsterdam, Department of Respiratory Medicine, Amsterdam, The Netherlands
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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 ERS Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) 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 3233 patients showed many differences in characteristics and life style factors. Current smokers ranged from 0% (Poland, PL, Sweden, SE) to 9.5% (Belgium, BE), mean BMI ranged from 26.2 (Italy) to 30.6 kg·m−2 (UK) and the largest difference in mean pre-bronchodilator FEV1% pred. was 20.9% (Netherlands versus Hungary). Before starting biologicals patients were treated differently between countries: mean ICS dose ranged from 700 to 1335 µg·day−1 between those from Slovenia (SL) versus PL when starting anti-IL-5 antibody and from 772 to 1344 µg·day−1 in those starting anti-IgE (SL versus Spain). Maintenance OCS use ranged from 21.0% (BE) to 63.0% (SE) and from 9.1% (Denmark) to 56.1% (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 ERS/ATS guidelines definition of severe asthma. Treatment regimens before starting biologicals were different from inclusion criteria in clinical trials and varied between countries.

Footnotes

This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.

Conflict of interest: Dr. van Bragt has nothing to disclose.

Conflict of interest: Dr. Adcock has nothing to disclose.

Conflict of interest: Dr. Bel reports grants and personal fees from AstraZeneca, GSK, Novartis, gand Teva, and personal fees from Boehringer Ingelheim, Sanofi/Regeneron, Vectura, and Sterna, outside the submitted work.

Conflict of interest: Dr. Braunstahl reports grants from GSK, grants from Novartis, grants from AstraZeneca, grants from Chiesi, outside the; submitted work.

Conflict of interest: Dr. ten Brinke reports institutional fees for research advisory boards and lectures from GSK, institutional fees for research advisory boards from Sanofi, institutional fees for research advisory boards from Novartis, institutional fees for research advisory boards and lectures from TEVA, institutional fees for research advisory boards and lectures from AstraZeneca and institutional fees for research advisory boards from Boehringer Ingelheim, outside the submitted work.

Conflict of interest: Dr. Busby has nothing to disclose.

Conflict of interest: Dr. CANONICA reports personal fees from A. MENARINI, personal fees from ASTRAZENECA, personal fees from BOEHRINGER INGELHEIM, personal fees from CHIESI FARMACEUTICI, personal fees from CIRCASSIA, personal fees from GLAXO SMITH KLINE, personal fees from MERCK SHARP & DOME, personal fees from NOVARTIS, personal fees from ROCHE, personal fees from SANOFI-AVENTIS, personal fees from TEVA, during the conduct of the study.

Conflict of interest: Dr. Cao reports and I am an employee of Novartis, which is one of the funding pharmaceutical companies of SHARP.

Conflict of interest: KFC has received honoraria for participating in Advisory Board meetings of GSK, AZ, Novartis, Merck, BI and TEVA regarding treatments for asthma and chronic obstructive pulmonary disease and has also been renumerated for speaking engagements.

Conflict of interest: Dr. Csoma has nothing to disclose.

Conflict of interest: Dr. Dahlén reports other from Teva, other from GSK, other from Sanofi, personal fees from AstraZeneca, outside the submitted work.

Conflict of interest: E Davin has nothing to disclose.

Conflict of interest: Dr Hansen has nothing to disclose.

Conflict of interest: Dr. Heffler reports personal fees from AstraZeneca, personal fees from Sanofi Genzyme, personal fees from Teva, personal fees from Novartis, personal fees from Glaxo-Smith & Kline, personal fees from Circassia, personal fees from Nestle Purina,outside the submitted work.

Conflict of interest: Dr. reports personal fees from AstraZeneca, personal fees from Boehringer-lngelheim, personal fees from GSK, personal fees from Chiesi, personal fees from Berlin-Chemie, personal fees from Roche, personal fees from MSD, personal fees from CSL, personal fees from Sager Pharma, outside the submitted work.

Conflict of interest: Dr. Korn reports personal fees from Almirall, personal fees from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Chiesi, grants and personal fees from GlaxoSmithKline, grants and personal fees from Novartis, personal fees from Teva, personal fees from Roche, during the conduct of the study.

Conflict of interest: Dr. Kots reports being full time Chiesi Famaceutici S.p.A. employee - Global clinical development department.

Conflict of interest: Dr. Kuna reports personal fees from AstraZeneca, personal fees and non-financial support from Berlin Chemie Menarini, personal fees and non-financial support from Boehringer Ingelheim, personal fees from Novartis, outside the submitted work.

Conflict of interest: Dr. KWON reports other from GlaxoSmithKline, during the conduct of the study; other from GlaxoSmithKline, outside the submitted work.

Conflict of interest: Dr. LOUIS reports grants and personal fees from GSK, grants and personal fees from AZ, grants and personal fees from Novartis, grants from Chiesi, outside the submitted work.

Conflict of interest: Dr. PLAZA reports grants, personal fees and non-financial support from Chiesi, grants and personal fees from AstraZeneca, personal fees from ALK, personal fees from Mundipharma, personal fees from Sanofi, grants from Menarini, outside the submitted work.

Conflict of interest: Dr Porsbjerg has nothing to disclose.

Conflict of interest: Dr. Ramos Barbon has nothing to disclose.

Conflict of interest: Dr Richards has nothing to disclose.

Conflict of interest: Dr. Skrgat reports personal fees from TEVA and Boehringer for lectures and scientific discussion at symposia, lectures and advisory boards (Astra Zeneca, Glaxo, Berlin-Chemie, Chiesi), outside the submitted work.

Conflict of interest: Dr. Sont has nothing to disclose.

Conflict of interest: Dr. Vijverberg has nothing to disclose.

Conflict of interest: Dr. weersink has nothing to disclose.

Conflict of interest: Dr. Yasinska has nothing to disclose.

Conflict of interest: Dr. Wagers reports other from European Respiratory Society, during the conduct of the study; other from Kings College Hospital NHS Foundation Trust, other from Academic Medical Research, other from AMC Medical Research BV, other from Asthma UK, other from Athens Medical School, other from Boehringer Ingelheim International GmbH, other from CHU de Toulouse, other from CIRO, other from DS Biologicals Ltd, other from ÉCOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE, other from European Respiratory Society, other from FISEVI, other from Fluidic Analytics Ltd., other from Fraunhofer IGB, other from Fraunhofer ITEM, other from GlaxoSmithKline Research & Dev Ltd, other from Holland & Knight, other from Karolinska Institutet Fakturor, other from KU Leuven, other from Longfonds, other from National Heart & Lung Institute, other from Novartis Pharma AG, other from Owlstone Medical Limited, other from PExA AB, other from UCB Biopharma S.P.R.L., other from UCB Biosciences GmbH, other from Umeå University, other from Univ. Hosptial Southampton NHS Foundation Trust, other from Università Campus Bio-Medico di Roma, other from Universita Cattolica Del Sacro Cuore, other from Universität Ulm, other from University of Bern, other from University of Edinburgh, other from University of Hull, other from University of Leicester, other from University of Loughborough, other from University of Luxembourg, other from University of Manchester, other from University of Notthingham, other from Vlaams Brabant, Dienst Europa, other from Imperial College London, other from Boehringer Ingelheim, other from Breathomix, other from Gossamer Bio, other from Astrazeneca, other from CIBER, from null, outside the submitted work.

Conflict of interest: Dr 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 GlaxoSmithKline. He is a co-founder and current consultant, and has shares in Synairgen, a University of Southampton spin out company.

Conflict of interest: Dr. Maitland-van der Zee reports personal fees for participating in an advisory board from Astra Zeneca, and Boehringer Ingelheim, unrestricted research grants from Boehringer Ingelheim, and GSK.

  • Received June 14, 2019.
  • Accepted September 18, 2019.
  • Copyright ©ERS 2019
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Characteristics and treatment regimens across ERS SHARP severe asthma registries
Job J.M.H. van Bragt, Ian M. Adcock, Elisabeth H.D. Bel, Gert-Jan Braunstahl, Anneke Ten Brinke, John Busby, Giorgio W. Canonica, Hui Cao, Kian Fan Chung, Zsuzsanna Csoma, Barbro Dahlen, Elizabeth Davin, Susanne Hansen, Enrico Heffler, Ildiko Horvath, Stephanie Korn, Maxim Kots, Piotr Kuna, Namhee Kwon, Renaud Louis, Vicente Plaza, Celeste Porsbjerg, David Ramos-Barbon, Levi B. Richards, Sabina Skrgat, Jacob K. Sont, Susanne J.H. Vijverberg, Els J. Weersink, Valentyna Yasinska, Scott S. Wagers, Ratko Djukanovic, Anke H. Maitland-van der Zee
European Respiratory Journal Jan 2019, 1901163; DOI: 10.1183/13993003.01163-2019

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Characteristics and treatment regimens across ERS SHARP severe asthma registries
Job J.M.H. van Bragt, Ian M. Adcock, Elisabeth H.D. Bel, Gert-Jan Braunstahl, Anneke Ten Brinke, John Busby, Giorgio W. Canonica, Hui Cao, Kian Fan Chung, Zsuzsanna Csoma, Barbro Dahlen, Elizabeth Davin, Susanne Hansen, Enrico Heffler, Ildiko Horvath, Stephanie Korn, Maxim Kots, Piotr Kuna, Namhee Kwon, Renaud Louis, Vicente Plaza, Celeste Porsbjerg, David Ramos-Barbon, Levi B. Richards, Sabina Skrgat, Jacob K. Sont, Susanne J.H. Vijverberg, Els J. Weersink, Valentyna Yasinska, Scott S. Wagers, Ratko Djukanovic, Anke H. Maitland-van der Zee
European Respiratory Journal Jan 2019, 1901163; DOI: 10.1183/13993003.01163-2019
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