Characterization of severe asthma worldwide: data from the International Severe Asthma Registry (ISAR)

Wang Eileen; Michael E Wechsler; Trung N Tran; Liam G Heaney; Rupert C Jones; Andrew N Menzies-Gow; John Busby; David J Jackson; Paul E Pfeffer; Chin Kook Rhee; You Sook Cho; G Walter Canonica; Enrico Heffler; Peter G Gibson; Mark Hew; Matthew Peters; Erin S Harvey; Mariana Alacqua; James Zangrilli; Lakmini Bulathsinhala; Victoria A Carter; Isha Chaudhry; Neva Eleangovan; Naeimeh Hosseini; Ruth B Murray; David B Price

doi:10.1016/j.chest.2019.10.053

Characterization of severe asthma worldwide: data from the International Severe Asthma Registry (ISAR)

Wang Eileen, Michael E Wechsler, Trung N Tran, Liam G Heaney, Rupert C Jones, Andrew N Menzies-Gow, John Busby, David J Jackson, Paul E Pfeffer, Chin Kook Rhee, You Sook Cho, G Walter Canonica, Enrico Heffler, Peter G Gibson, Mark Hew, Matthew Peters, Erin S Harvey, Mariana Alacqua, James Zangrilli, Lakmini BulathsinhalaVictoria A Carter, Isha Chaudhry, Neva Eleangovan, Naeimeh Hosseini, Ruth B Murray, David B Price^*

^*Corresponding author for this work

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

171 Citations (Scopus)

3 Downloads (Pure)

Abstract

BACKGROUND: To date, clinical characteristics of the international severe asthma population are unknown. Inter-country comparisons are hindered by variable data collection within regional/national severe asthma registries. Our aim was to describe demographic and clinical characteristics of patients managed in severe asthma services in the USA, Europe, and Asia/Pacific region.

METHODS: The International Severe Asthma Registry (ISAR) retrospectively and prospectively collected data on severe asthma patients (≥18 years old), receiving GINA Step 5 treatment or remaining uncontrolled on GINA Step 4. Baseline demographic and clinical data were collected from the U.S., UK, South Korea, Italy, and the SAWD registry (including Australia, Singapore and New Zealand) from December 2014-December 2017.

RESULTS: 4,990 patients were included. Average age was 55.0 (SD: 15.9) years, and age at asthma onset 30.7 (SD: 17.7) years. Patients were predominantly female (59.3%), white (72.6%), had never smoked (60.5%) and were over-weight/obese (70.4%). 34.9% were on GINA Step 5. 57.2% had poorly controlled disease. 51.1% of patients were on regular intermittent OCS and 25.4% were on biologics (72.6% for those on GINA Step 5). Mean exacerbation rate was 1.7 (SD: 2.7) per year. Inter-country variation was observed in clinical characteristics, prescribed treatments and biomarker profiles.

CONCLUSIONS: Using a common dataset and definitions, this study is the first to describe severe asthma characteristics of a large cohort of patients included in multiple severe asthma registries, and to identify country differences. Whether these are related to underlying epidemiological, environmental factors, phenotype, asthma management systems, treatment access and/or cultural factors requires further study.

Original language	English
Pages (from-to)	790-804
Number of pages	15
Journal	Chest
Volume	157
Issue number	4
Early online date	27 Nov 2019
DOIs	https://doi.org/10.1016/j.chest.2019.10.053
Publication status	Published - 1 Apr 2020

Bibliographical note

Funding Information:
Financial/nonfinancial disclosures: The authors have reported to CHEST the following: E. W. has received advisory board fees from AstraZeneca. She has been an investigator on clinical trials sponsored by GlaxoSmithKline, Teva, AstraZeneca, Novartis, National Institute of Allergy and Infectious Diseases (NIAID) for which her institution has received funding. She has received funding for investigator-initiated studies from Self Care Catalysts, Genentech, and GlaxoSmithKline. M. E. W. has received consulting honoraria from AstraZeneca plc, Boehringer Ingelheim, Genentech Inc, GlaxoSmithKline plc, Novartis International AG, Regeneron Pharmaceuticals Inc, Sanofi SA, Teva Pharmaceutical Industries Ltd and Equillium. T. N. T., M. A., and J. Z. are employees of AstraZeneca plc, a cofunder of the International Severe Asthma Registry. L. G. H. is Academic Lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma - Industrial Pharma partners Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche / Genentech, GlaxoSmithKline, and Boehringer Ingelheim; prior project grant funding from Medimmune, Novartis UK, Roche / Genentech, and GlaxoSmithKline; has taken part in Advisory Boards / Lectures supported by Novartis,Roche / Evelo Biosciences, Genentech, GlaxoSmithKline, Teva, Theravance and Vectura; has travel funding support to international respiratory meetings (AstraZeneca, Chiesi, Novartis, Boehringer Ingelheim, Teva, and GlaxoSmithKline) and has taken part in asthma clinical trials (GlaxoSmithKline, Schering Plough, Synairgen, Novartis, and Roche / Genentech) for which his institution was remunerated. R. C. J. declares grants from AstraZeneca, GlaxoSmithKline, and Novartis; and personal fees for consultancy, speakers fees, or travel support from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Nutricia, Observational & Pragmatic Research Institute, and Pfizer. A. N. M. G. declares grants from AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, and Hoffmann La Roche AG; consultancy agreements with AstraZeneca plc, Sanofi SA, and Vectura Group plc; attendance at advisory boards for AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, Novartis International AG, Sanofi SA, and Teva Pharmaceutical Industries Ltd; speaker fees from AstraZeneca plc, Boehringer Ingelheim, Novartis International AG, Teva Pharmaceutical Industries Ltd, and Vectura Group plc; and attendance at international conferences for Boehringer Ingelheim and Teva Pharmaceutical Industries Ltd. D. J. J. has received advisory board and speaker fees from AstraZeneca plc, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline plc, Napp Pharmaceuticals Limited, Novartis International AG, and Teva Pharmaceutical Industries Ltd and research grant funding from AstraZeneca plc. P. E. P. has attended advisory boards for Novartis International AG; has given lectures at meetings supported by AstraZeneca plc and GlaxoSmithKline plc; and has taken part in clinical trials sponsored by AstraZeneca plc, GlaxoSmithKline plc, and Novartis International AG, for which his institution received remuneration. C. K. R. declares consultancy and lecture fees from AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, Merck Sharp & Dohme Ltd, Mundipharma International Limited, Novartis International AG, Sandoz, Takeda Pharmaceutical Company Limited, and Teva-Handok Pharma Co Ltd. G. W. C. has received research grants and lecture or advisory board fees from A. Menarini Diagnostics Ltd, Allergy Therapeutics PLC, ALK-Abelló A/S, Anallergo SpA, AstraZeneca plc, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia Pharmaceuticals, Danone SA, Faes Farma, Genentech Inc, Genzyme/Regeneron, GlaxoSmithKline plc, HAL Allergy Group, Laboratori Guidotti spa, Malesci Istituto Farmacobiologico spa, MedImmune LLC, Merck & Co Inc, Merck Sharp & Dohme Ltd, Mundipharma International Limited, Novartis International AG, Orion Pharma Ltd, Sanofi SA, Stallergenes Greer Ltd, Teva Pharmaceutical Industries Ltd, Thermo Fisher Scientific, UCB Pharmaceuticals, Uriach Group, and Valeas SpA. E. H. participates in speaking activities and industry advisory committees for AstraZeneca, Sanofi-Genzyme, GSK, Novartis, TEVA, Circassia and Nestlè Purina. P. G. G. declares speaker fees and grants to his institution from AstraZeneca plc, GlaxoSmithKline plc, and Novartis International AG for unrelated projects. M. H. has received grants-in-aid, speaker fees, and fees for serving on the advisory boards of; GlaxoSmithKline, AstraZeneca, Novartis, Teva, and Sanofi, all unrelated to the current manuscript, and all paid to his institutional employer Alfred Health. M. P. declares personal fees and nonfinancial support from AstraZeneca and GlaxoSmithKline. L. B., V. A. C., I. C., N. E., and N. H. are employees of Optimum Patient Care Global Ltd, a cofunder of the International Severe Asthma Registry. D. B. P. has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. None declared (J. B., Y. S. C., E. S. H., R. B. M.).

Keywords

biologics
co-morbidity
eosinophils
FeNO
IgE

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wang-et-al-characterization-severe-chest-vor
Copyright © 2020 The Authors. Published by Elsevier Inc under license from the American College of Chest Physicians. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
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Cite this

Eileen, W., Wechsler, M. E., Tran, T. N., Heaney, L. G., Jones, R. C., Menzies-Gow, A. N., Busby, J., Jackson, D. J., Pfeffer, P. E., Rhee, C. K., Cho, Y. S., Canonica, G. W., Heffler, E., Gibson, P. G., Hew, M., Peters, M., Harvey, E. S., Alacqua, M., Zangrilli, J., ... Price, D. B. (2020). Characterization of severe asthma worldwide: data from the International Severe Asthma Registry (ISAR). Chest, 157(4), 790-804. https://doi.org/10.1016/j.chest.2019.10.053

Eileen, W, Wechsler, ME, Tran, TN, Heaney, LG, Jones, RC, Menzies-Gow, AN, Busby, J, Jackson, DJ, Pfeffer, PE, Rhee, CK, Cho, YS, Canonica, GW, Heffler, E, Gibson, PG, Hew, M, Peters, M, Harvey, ES, Alacqua, M, Zangrilli, J, Bulathsinhala, L, Carter, VA, Chaudhry, I, Eleangovan, N, Hosseini, N, Murray, RB & Price, DB 2020, 'Characterization of severe asthma worldwide: data from the International Severe Asthma Registry (ISAR)', Chest, vol. 157, no. 4, pp. 790-804. https://doi.org/10.1016/j.chest.2019.10.053

@article{9745ee2c6c224c12861284682b4b9b15,

title = "Characterization of severe asthma worldwide: data from the International Severe Asthma Registry (ISAR)",

abstract = "BACKGROUND: To date, clinical characteristics of the international severe asthma population are unknown. Inter-country comparisons are hindered by variable data collection within regional/national severe asthma registries. Our aim was to describe demographic and clinical characteristics of patients managed in severe asthma services in the USA, Europe, and Asia/Pacific region.METHODS: The International Severe Asthma Registry (ISAR) retrospectively and prospectively collected data on severe asthma patients (≥18 years old), receiving GINA Step 5 treatment or remaining uncontrolled on GINA Step 4. Baseline demographic and clinical data were collected from the U.S., UK, South Korea, Italy, and the SAWD registry (including Australia, Singapore and New Zealand) from December 2014-December 2017.RESULTS: 4,990 patients were included. Average age was 55.0 (SD: 15.9) years, and age at asthma onset 30.7 (SD: 17.7) years. Patients were predominantly female (59.3%), white (72.6%), had never smoked (60.5%) and were over-weight/obese (70.4%). 34.9% were on GINA Step 5. 57.2% had poorly controlled disease. 51.1% of patients were on regular intermittent OCS and 25.4% were on biologics (72.6% for those on GINA Step 5). Mean exacerbation rate was 1.7 (SD: 2.7) per year. Inter-country variation was observed in clinical characteristics, prescribed treatments and biomarker profiles.CONCLUSIONS: Using a common dataset and definitions, this study is the first to describe severe asthma characteristics of a large cohort of patients included in multiple severe asthma registries, and to identify country differences. Whether these are related to underlying epidemiological, environmental factors, phenotype, asthma management systems, treatment access and/or cultural factors requires further study.",

keywords = "biologics, co-morbidity, eosinophils, FeNO, IgE",

author = "Wang Eileen and Wechsler, {Michael E} and Tran, {Trung N} and Heaney, {Liam G} and Jones, {Rupert C} and Menzies-Gow, {Andrew N} and John Busby and Jackson, {David J} and Pfeffer, {Paul E} and Rhee, {Chin Kook} and Cho, {You Sook} and Canonica, {G Walter} and Enrico Heffler and Gibson, {Peter G} and Mark Hew and Matthew Peters and Harvey, {Erin S} and Mariana Alacqua and James Zangrilli and Lakmini Bulathsinhala and Carter, {Victoria A} and Isha Chaudhry and Neva Eleangovan and Naeimeh Hosseini and Murray, {Ruth B} and Price, {David B}",

note = "Funding Information: Financial/nonfinancial disclosures: The authors have reported to CHEST the following: E. W. has received advisory board fees from AstraZeneca. She has been an investigator on clinical trials sponsored by GlaxoSmithKline, Teva, AstraZeneca, Novartis, National Institute of Allergy and Infectious Diseases (NIAID) for which her institution has received funding. She has received funding for investigator-initiated studies from Self Care Catalysts, Genentech, and GlaxoSmithKline. M. E. W. has received consulting honoraria from AstraZeneca plc, Boehringer Ingelheim, Genentech Inc, GlaxoSmithKline plc, Novartis International AG, Regeneron Pharmaceuticals Inc, Sanofi SA, Teva Pharmaceutical Industries Ltd and Equillium. T. N. T., M. A., and J. Z. are employees of AstraZeneca plc, a cofunder of the International Severe Asthma Registry. L. G. H. is Academic Lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma - Industrial Pharma partners Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche / Genentech, GlaxoSmithKline, and Boehringer Ingelheim; prior project grant funding from Medimmune, Novartis UK, Roche / Genentech, and GlaxoSmithKline; has taken part in Advisory Boards / Lectures supported by Novartis,Roche / Evelo Biosciences, Genentech, GlaxoSmithKline, Teva, Theravance and Vectura; has travel funding support to international respiratory meetings (AstraZeneca, Chiesi, Novartis, Boehringer Ingelheim, Teva, and GlaxoSmithKline) and has taken part in asthma clinical trials (GlaxoSmithKline, Schering Plough, Synairgen, Novartis, and Roche / Genentech) for which his institution was remunerated. R. C. J. declares grants from AstraZeneca, GlaxoSmithKline, and Novartis; and personal fees for consultancy, speakers fees, or travel support from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Nutricia, Observational & Pragmatic Research Institute, and Pfizer. A. N. M. G. declares grants from AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, and Hoffmann La Roche AG; consultancy agreements with AstraZeneca plc, Sanofi SA, and Vectura Group plc; attendance at advisory boards for AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, Novartis International AG, Sanofi SA, and Teva Pharmaceutical Industries Ltd; speaker fees from AstraZeneca plc, Boehringer Ingelheim, Novartis International AG, Teva Pharmaceutical Industries Ltd, and Vectura Group plc; and attendance at international conferences for Boehringer Ingelheim and Teva Pharmaceutical Industries Ltd. D. J. J. has received advisory board and speaker fees from AstraZeneca plc, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline plc, Napp Pharmaceuticals Limited, Novartis International AG, and Teva Pharmaceutical Industries Ltd and research grant funding from AstraZeneca plc. P. E. P. has attended advisory boards for Novartis International AG; has given lectures at meetings supported by AstraZeneca plc and GlaxoSmithKline plc; and has taken part in clinical trials sponsored by AstraZeneca plc, GlaxoSmithKline plc, and Novartis International AG, for which his institution received remuneration. C. K. R. declares consultancy and lecture fees from AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, Merck Sharp & Dohme Ltd, Mundipharma International Limited, Novartis International AG, Sandoz, Takeda Pharmaceutical Company Limited, and Teva-Handok Pharma Co Ltd. G. W. C. has received research grants and lecture or advisory board fees from A. Menarini Diagnostics Ltd, Allergy Therapeutics PLC, ALK-Abell{\'o} A/S, Anallergo SpA, AstraZeneca plc, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia Pharmaceuticals, Danone SA, Faes Farma, Genentech Inc, Genzyme/Regeneron, GlaxoSmithKline plc, HAL Allergy Group, Laboratori Guidotti spa, Malesci Istituto Farmacobiologico spa, MedImmune LLC, Merck & Co Inc, Merck Sharp & Dohme Ltd, Mundipharma International Limited, Novartis International AG, Orion Pharma Ltd, Sanofi SA, Stallergenes Greer Ltd, Teva Pharmaceutical Industries Ltd, Thermo Fisher Scientific, UCB Pharmaceuticals, Uriach Group, and Valeas SpA. E. H. participates in speaking activities and industry advisory committees for AstraZeneca, Sanofi-Genzyme, GSK, Novartis, TEVA, Circassia and Nestl{\`e} Purina. P. G. G. declares speaker fees and grants to his institution from AstraZeneca plc, GlaxoSmithKline plc, and Novartis International AG for unrelated projects. M. H. has received grants-in-aid, speaker fees, and fees for serving on the advisory boards of; GlaxoSmithKline, AstraZeneca, Novartis, Teva, and Sanofi, all unrelated to the current manuscript, and all paid to his institutional employer Alfred Health. M. P. declares personal fees and nonfinancial support from AstraZeneca and GlaxoSmithKline. L. B., V. A. C., I. C., N. E., and N. H. are employees of Optimum Patient Care Global Ltd, a cofunder of the International Severe Asthma Registry. D. B. P. has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. None declared (J. B., Y. S. C., E. S. H., R. B. M.). ",

year = "2020",

month = apr,

day = "1",

doi = "10.1016/j.chest.2019.10.053",

language = "English",

volume = "157",

pages = "790--804",

journal = "Chest",

issn = "0012-3692",

publisher = "American College of Chest Physicians",

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}

TY - JOUR

T1 - Characterization of severe asthma worldwide

T2 - data from the International Severe Asthma Registry (ISAR)

AU - Eileen, Wang

AU - Wechsler, Michael E

AU - Tran, Trung N

AU - Heaney, Liam G

AU - Jones, Rupert C

AU - Menzies-Gow, Andrew N

AU - Busby, John

AU - Jackson, David J

AU - Pfeffer, Paul E

AU - Rhee, Chin Kook

AU - Cho, You Sook

AU - Canonica, G Walter

AU - Heffler, Enrico

AU - Gibson, Peter G

AU - Hew, Mark

AU - Peters, Matthew

AU - Harvey, Erin S

AU - Alacqua, Mariana

AU - Zangrilli, James

AU - Bulathsinhala, Lakmini

AU - Carter, Victoria A

AU - Chaudhry, Isha

AU - Eleangovan, Neva

AU - Hosseini, Naeimeh

AU - Murray, Ruth B

AU - Price, David B

N1 - Funding Information: Financial/nonfinancial disclosures: The authors have reported to CHEST the following: E. W. has received advisory board fees from AstraZeneca. She has been an investigator on clinical trials sponsored by GlaxoSmithKline, Teva, AstraZeneca, Novartis, National Institute of Allergy and Infectious Diseases (NIAID) for which her institution has received funding. She has received funding for investigator-initiated studies from Self Care Catalysts, Genentech, and GlaxoSmithKline. M. E. W. has received consulting honoraria from AstraZeneca plc, Boehringer Ingelheim, Genentech Inc, GlaxoSmithKline plc, Novartis International AG, Regeneron Pharmaceuticals Inc, Sanofi SA, Teva Pharmaceutical Industries Ltd and Equillium. T. N. T., M. A., and J. Z. are employees of AstraZeneca plc, a cofunder of the International Severe Asthma Registry. L. G. H. is Academic Lead for the UK MRC Consortium for Stratified Medicine in Severe Asthma - Industrial Pharma partners Amgen, AstraZeneca, Medimmune, Janssen, Novartis, Roche / Genentech, GlaxoSmithKline, and Boehringer Ingelheim; prior project grant funding from Medimmune, Novartis UK, Roche / Genentech, and GlaxoSmithKline; has taken part in Advisory Boards / Lectures supported by Novartis,Roche / Evelo Biosciences, Genentech, GlaxoSmithKline, Teva, Theravance and Vectura; has travel funding support to international respiratory meetings (AstraZeneca, Chiesi, Novartis, Boehringer Ingelheim, Teva, and GlaxoSmithKline) and has taken part in asthma clinical trials (GlaxoSmithKline, Schering Plough, Synairgen, Novartis, and Roche / Genentech) for which his institution was remunerated. R. C. J. declares grants from AstraZeneca, GlaxoSmithKline, and Novartis; and personal fees for consultancy, speakers fees, or travel support from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Nutricia, Observational & Pragmatic Research Institute, and Pfizer. A. N. M. G. declares grants from AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, and Hoffmann La Roche AG; consultancy agreements with AstraZeneca plc, Sanofi SA, and Vectura Group plc; attendance at advisory boards for AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, Novartis International AG, Sanofi SA, and Teva Pharmaceutical Industries Ltd; speaker fees from AstraZeneca plc, Boehringer Ingelheim, Novartis International AG, Teva Pharmaceutical Industries Ltd, and Vectura Group plc; and attendance at international conferences for Boehringer Ingelheim and Teva Pharmaceutical Industries Ltd. D. J. J. has received advisory board and speaker fees from AstraZeneca plc, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline plc, Napp Pharmaceuticals Limited, Novartis International AG, and Teva Pharmaceutical Industries Ltd and research grant funding from AstraZeneca plc. P. E. P. has attended advisory boards for Novartis International AG; has given lectures at meetings supported by AstraZeneca plc and GlaxoSmithKline plc; and has taken part in clinical trials sponsored by AstraZeneca plc, GlaxoSmithKline plc, and Novartis International AG, for which his institution received remuneration. C. K. R. declares consultancy and lecture fees from AstraZeneca plc, Boehringer Ingelheim, GlaxoSmithKline plc, Merck Sharp & Dohme Ltd, Mundipharma International Limited, Novartis International AG, Sandoz, Takeda Pharmaceutical Company Limited, and Teva-Handok Pharma Co Ltd. G. W. C. has received research grants and lecture or advisory board fees from A. Menarini Diagnostics Ltd, Allergy Therapeutics PLC, ALK-Abelló A/S, Anallergo SpA, AstraZeneca plc, Boehringer Ingelheim, Chiesi Farmaceutici, Circassia Pharmaceuticals, Danone SA, Faes Farma, Genentech Inc, Genzyme/Regeneron, GlaxoSmithKline plc, HAL Allergy Group, Laboratori Guidotti spa, Malesci Istituto Farmacobiologico spa, MedImmune LLC, Merck & Co Inc, Merck Sharp & Dohme Ltd, Mundipharma International Limited, Novartis International AG, Orion Pharma Ltd, Sanofi SA, Stallergenes Greer Ltd, Teva Pharmaceutical Industries Ltd, Thermo Fisher Scientific, UCB Pharmaceuticals, Uriach Group, and Valeas SpA. E. H. participates in speaking activities and industry advisory committees for AstraZeneca, Sanofi-Genzyme, GSK, Novartis, TEVA, Circassia and Nestlè Purina. P. G. G. declares speaker fees and grants to his institution from AstraZeneca plc, GlaxoSmithKline plc, and Novartis International AG for unrelated projects. M. H. has received grants-in-aid, speaker fees, and fees for serving on the advisory boards of; GlaxoSmithKline, AstraZeneca, Novartis, Teva, and Sanofi, all unrelated to the current manuscript, and all paid to his institutional employer Alfred Health. M. P. declares personal fees and nonfinancial support from AstraZeneca and GlaxoSmithKline. L. B., V. A. C., I. C., N. E., and N. H. are employees of Optimum Patient Care Global Ltd, a cofunder of the International Severe Asthma Registry. D. B. P. has board membership with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermofisher; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; funding for patient enrolment or completion of research from Novartis; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is peer reviewer for grant committees of the Efficacy and Mechanism Evaluation programme, and Health Technology Assessment. None declared (J. B., Y. S. C., E. S. H., R. B. M.).

PY - 2020/4/1

Y1 - 2020/4/1

N2 - BACKGROUND: To date, clinical characteristics of the international severe asthma population are unknown. Inter-country comparisons are hindered by variable data collection within regional/national severe asthma registries. Our aim was to describe demographic and clinical characteristics of patients managed in severe asthma services in the USA, Europe, and Asia/Pacific region.METHODS: The International Severe Asthma Registry (ISAR) retrospectively and prospectively collected data on severe asthma patients (≥18 years old), receiving GINA Step 5 treatment or remaining uncontrolled on GINA Step 4. Baseline demographic and clinical data were collected from the U.S., UK, South Korea, Italy, and the SAWD registry (including Australia, Singapore and New Zealand) from December 2014-December 2017.RESULTS: 4,990 patients were included. Average age was 55.0 (SD: 15.9) years, and age at asthma onset 30.7 (SD: 17.7) years. Patients were predominantly female (59.3%), white (72.6%), had never smoked (60.5%) and were over-weight/obese (70.4%). 34.9% were on GINA Step 5. 57.2% had poorly controlled disease. 51.1% of patients were on regular intermittent OCS and 25.4% were on biologics (72.6% for those on GINA Step 5). Mean exacerbation rate was 1.7 (SD: 2.7) per year. Inter-country variation was observed in clinical characteristics, prescribed treatments and biomarker profiles.CONCLUSIONS: Using a common dataset and definitions, this study is the first to describe severe asthma characteristics of a large cohort of patients included in multiple severe asthma registries, and to identify country differences. Whether these are related to underlying epidemiological, environmental factors, phenotype, asthma management systems, treatment access and/or cultural factors requires further study.

AB - BACKGROUND: To date, clinical characteristics of the international severe asthma population are unknown. Inter-country comparisons are hindered by variable data collection within regional/national severe asthma registries. Our aim was to describe demographic and clinical characteristics of patients managed in severe asthma services in the USA, Europe, and Asia/Pacific region.METHODS: The International Severe Asthma Registry (ISAR) retrospectively and prospectively collected data on severe asthma patients (≥18 years old), receiving GINA Step 5 treatment or remaining uncontrolled on GINA Step 4. Baseline demographic and clinical data were collected from the U.S., UK, South Korea, Italy, and the SAWD registry (including Australia, Singapore and New Zealand) from December 2014-December 2017.RESULTS: 4,990 patients were included. Average age was 55.0 (SD: 15.9) years, and age at asthma onset 30.7 (SD: 17.7) years. Patients were predominantly female (59.3%), white (72.6%), had never smoked (60.5%) and were over-weight/obese (70.4%). 34.9% were on GINA Step 5. 57.2% had poorly controlled disease. 51.1% of patients were on regular intermittent OCS and 25.4% were on biologics (72.6% for those on GINA Step 5). Mean exacerbation rate was 1.7 (SD: 2.7) per year. Inter-country variation was observed in clinical characteristics, prescribed treatments and biomarker profiles.CONCLUSIONS: Using a common dataset and definitions, this study is the first to describe severe asthma characteristics of a large cohort of patients included in multiple severe asthma registries, and to identify country differences. Whether these are related to underlying epidemiological, environmental factors, phenotype, asthma management systems, treatment access and/or cultural factors requires further study.

KW - biologics

KW - co-morbidity

KW - eosinophils

KW - FeNO

KW - IgE

UR - http://www.scopus.com/inward/record.url?scp=85081611905&partnerID=8YFLogxK

U2 - 10.1016/j.chest.2019.10.053

DO - 10.1016/j.chest.2019.10.053

M3 - Article

C2 - 31785254

SN - 0012-3692

VL - 157

SP - 790

EP - 804

JO - Chest

JF - Chest

IS - 4

ER -

Characterization of severe asthma worldwide: data from the International Severe Asthma Registry (ISAR)

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