Disease Burden and Access to Biologic Therapy in Patients with Severe Asthma, 2017-2022: An Analysis of the International Severe Asthma Registry

Tham T Le¹, David B Price^{2

3

4}, Clement Erhard⁵, Bill Cook⁶, Anna Quinton⁷, Rohit Katial⁸, George C Christoff⁹, Luis Perez-de-Llano¹⁰, Alan Altraja^{11

12}, Celine Bergeron¹³, Arnaud Bourdin¹⁴, Mariko Siyue Koh^{15

16}, Lauri Lehtimäki^{17

18}, Bassam Mahboub¹⁹, Nikolaos G Papadopoulos^{20

21}, Paul Pfeffer^{22

23}, Chin Kook Rhee²⁴, Victoria Carter^{2

3}, Neil Martin^{25

26}, Trung N Tran¹; EVEREST Study Working Group

Affiliations

¹ BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
² Observational and Pragmatic Research Institute, Singapore.
³ Optimum Patient Care Global, Cambridge, UK.
⁴ Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
⁵ BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
⁶ Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
⁷ BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
⁸ Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
⁹ Faculty of Public Health, Medical University Sofia, Sofia, Bulgaria.
¹⁰ Department of Respiratory Medicine, University Hospital Lucus Augusti, Lugo, Spain.
¹¹ Department of Pulmonology, University of Tartu, Tartu, Estonia.
¹² Lung Clinic, Tartu University Hospital, Tartu, Estonia.
¹³ Centre for Lung Health, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
¹⁴ PhyMedExp, University of Montpellier, CNRS, INSERM, University Hospital of Montpellier, Montpellier, France.
¹⁵ Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore.
¹⁶ Duke-NUS Medical School, Singapore.
¹⁷ Allergy Centre, Tampere University Hospital, Tampere, Finland.
¹⁸ Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
¹⁹ Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates.
²⁰ Division of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester, UK.
²¹ Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.
²² Department of Respiratory Medicine, Barts Health NHS Trust, London, UK.
²³ Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
²⁴ Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Seoul St. Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, South Korea.
²⁵ Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
²⁶ University of Leicester, Leicester, UK.

PMID: 39479509
PMCID: PMC11522015
DOI: 10.2147/JAA.S468068

Disease Burden and Access to Biologic Therapy in Patients with Severe Asthma, 2017-2022: An Analysis of the International Severe Asthma Registry

Tham T Le et al. J Asthma Allergy. 2024.

. 2024 Oct 25:17:1055-1069.

doi: 10.2147/JAA.S468068. eCollection 2024.

Authors

Affiliations

¹ BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
² Observational and Pragmatic Research Institute, Singapore.
³ Optimum Patient Care Global, Cambridge, UK.
⁴ Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
⁵ BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
⁶ Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
⁷ BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
⁸ Global Medical Respiratory, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA.
⁹ Faculty of Public Health, Medical University Sofia, Sofia, Bulgaria.
¹⁰ Department of Respiratory Medicine, University Hospital Lucus Augusti, Lugo, Spain.
¹¹ Department of Pulmonology, University of Tartu, Tartu, Estonia.
¹² Lung Clinic, Tartu University Hospital, Tartu, Estonia.
¹³ Centre for Lung Health, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
¹⁴ PhyMedExp, University of Montpellier, CNRS, INSERM, University Hospital of Montpellier, Montpellier, France.
¹⁵ Respiratory and Critical Care Medicine, Singapore General Hospital, Singapore.
¹⁶ Duke-NUS Medical School, Singapore.
¹⁷ Allergy Centre, Tampere University Hospital, Tampere, Finland.
¹⁸ Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
¹⁹ Rashid Hospital, Dubai Health Authority, Dubai, United Arab Emirates.
²⁰ Division of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester, UK.
²¹ Allergy Department, 2nd Pediatric Clinic, University of Athens, Athens, Greece.
²² Department of Respiratory Medicine, Barts Health NHS Trust, London, UK.
²³ Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
²⁴ Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Seoul St. Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, South Korea.
²⁵ Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
²⁶ University of Leicester, Leicester, UK.

PMID: 39479509
PMCID: PMC11522015
DOI: 10.2147/JAA.S468068

Abstract

Introduction: Patients with severe asthma may be prescribed biologic therapies to improve disease control. The EVEREST study aimed to characterize the global disease burden of patients with severe asthma without access to biologics and those who have access but do not receive biologics, as well as the remaining unmet need despite use of these therapies.

Methods: This was a historical cohort study of patients with severe asthma (aged ≥18 years) in the International Severe Asthma Registry receiving Global Initiative for Asthma (GINA) 2018 step 5 treatment, or with uncontrolled disease at GINA step 4. Prospective data on patient clinical characteristics, healthcare resource utilization, and medication use over a 12-month period between December 2017 and May 2022 were assessed for the following five groups: biologics accessible (omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab); biologics inaccessible; biologics accessible but not received; biologics accessible and received; and biologic recipients whose asthma remained suboptimally controlled.

Results: Overall, 9587 patients from 21 countries were included. Among patients in the biologics accessible (n=5073), biologics inaccessible (n=3041), and biologics accessible but not received (n=382) groups, 41.4%, 18.7%, and 49.6% experienced at least two exacerbations, 11.5%, 10.5%, and 6.2% required at least one hospitalization, 47.9%, 54.6%, and 71.2% had uncontrolled asthma, and 23.9%, 8.6%, and 11.0% received long-term oral corticosteroids (LTOCS), respectively. Following biologic therapy, among patients who received biologics overall (n=2666) and among those whose asthma remained suboptimally controlled (n=1780), 19.1% and 23.0% experienced at least two exacerbations, 2.7% and 2.9% required at least one hospitalization, and 16.7% and 22.0% received LTOCS, respectively.

Conclusion: There is a substantial disease burden in both patients without access to biologics and those with access who do not receive these therapies, although specific outcomes may vary between these groups. There also remains a high unmet need among biologic recipients, many of whom have a suboptimal response to treatment.

Keywords: biologic; disease burden; healthcare resource utilization; severe asthma.

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Conflict of interest statement

Tham T. Le, Clement Erhard, Bill Cook, Anna Quinton, Neil Martin, and Trung N. Tran are employees of AstraZeneca and may own stock or stock options in AstraZeneca. David B Price has participated in advisory boards with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mundipharma, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Thermo Fisher, and Viatris; has consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GSK, Medscape, Mundipharma, Novartis, Pfizer, Teva Pharmaceuticals, Theravance, and Viatris; has received grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, the UK National Health Service, and Viatris; has received payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GSK, Mundipharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals, and Viatris; has received payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma, Novartis, Teva Pharmaceuticals, and Thermo Fisher; has received funding for patient enrollment or completion of research from Novartis; has stock or stock options with AKL Research and Development Ltd; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); owns 5% shareholding in Timestamp; is a peer reviewer for Health Technology Assessment and the grant committees of the UK Efficacy and Mechanism Evaluation Programme; and was an expert witness for GSK. Rohit Katial is a former employee of AstraZeneca and has been an advisory board participant and speaker for GSK and Sanofi/Regeneron. Luis Perez-de-Llano has received grants from AstraZeneca, Chiesi, and Teva Pharmaceuticals; personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Esteve, FAES, GEBRO, GSK, Mundipharma, Novartis, Sanofi, and Teva Pharmaceuticals; and nonfinancial support from Boehringer Ingelheim, Esteve, GSK, Menarini, Mundipharma, Novartis, and Teva Pharmaceuticals. Alan Altraja has received lecture fees from AstraZeneca, Berlin-Chemie Menarini, Boehringer Ingelheim, CSL Behring, GSK, MSD, Norameda, Novartis, Orion, Sanofi Regeneron, and Zentiva; sponsorships from AstraZeneca, Berlin-Chemie Menarini, Boehringer Ingelheim, CSL Behring, GSK, MSD, Norameda, Novartis, and Sanofi Regeneron; and has participated in advisory boards for AstraZeneca, Boehringer Ingelheim, CSL Behring, GSK, Novartis, Sanofi Regeneron, and Teva Pharmaceuticals. Celine Bergeron has participated in advisory boards for GSK, Sanofi-Regeneron, AstraZeneca, Amgen, Takeda, and Valeo Pharma; has received honoraria for presentations for AstraZeneca, Amgen, Grifols, GSK, Sanofi-Regeneron, and Valeo Pharma; and her institution has received grants from AstraZeneca, Biohaven, GSK, OPRI/ISAR, Novartis, Sanofi-Regeneron and Teva. Arnaud Bourdin has received industry-sponsored grants from AstraZeneca, Boehringer Ingelheim, Cephalon/Teva, GSK, Novartis, and Sanofi-Regeneron; and been a consultant for Actelion, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, MedinCell, Merck, Novartis, Regeneron-Sanofi, and Roche. Mariko Siyue Koh has received grants from AstraZeneca; and honoraria for lectures and advisory board meetings paid to her hospital (Singapore General Hospital) from GSK, AstraZeneca, Boehringer Ingelheim, Novartis, Roche, and Sanofi. Lauri Lehtimäki has received personal fees from ALK, AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, GSK, Menarini, Novartis, Orion Pharma, and Sanofi. Nikolaos G Papadopoulos has been a speaker and/or advisory board member for Abbott, AbbVie, ALK, Asit Biotech, AstraZeneca, Biomay, Boehringer Ingelheim, GSK, HAL, Faes Farma, Medscape, Menarini, MSD, Mylan, Novartis, Nutricia, OM Pharma, Regeneron, Sanofi, Takeda, and Viatris. Paul Pfeffer has attended advisory boards for AstraZeneca, GSK, and Sanofi; has given lectures at meetings supported by AstraZeneca and GSK; has taken part in clinical trials sponsored by AstraZeneca, GSK, Novartis, and Sanofi, for which his institution received remuneration; has received speaker fee from Chiesi for an educational webinar and has a current research grant funded by GSK. Chin Kook Rhee received consulting/lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, GSK, MSD, Mundipharma, Novartis, Sanofi, Takeda, and Teva. Victoria Carter is an employee of Optimum Patient Care, a co-funder of ISAR. The authors report no other conflicts of interest in this work.

Figures

**Figure 1**
Patient groups evaluated during the baseline period and follow-up period (following biologic therapy).

**Figure 2**
Proportions of patients with severe asthma who experienced at least two exacerbations (A), who had uncontrolled asthma (B), or who were receiving LTOCS (C) during the baseline period and follow-up period (following biologic therapy), by biologic accessibility and use.

See this image and copyright information in PMC

References

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Disease Burden and Access to Biologic Therapy in Patients with Severe Asthma, 2017-2022: An Analysis of the International Severe Asthma Registry

Affiliations

Disease Burden and Access to Biologic Therapy in Patients with Severe Asthma, 2017-2022: An Analysis of the International Severe Asthma Registry

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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