Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)

Clementine Nordon,1 Donna Carstens,2 Malin Fagerås,3 Hana Müllerová,1 Phani S Veeranki,4 João André Alves,3 Hayley D Germack,2 Timothy L Barnes,4 Meredith C McCormack5 1Respiratory Evidence Strategy, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK; 2US Medical Evidence, Biopharmaceuticals, As...

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Main Authors: Nordon C, Carstens D, Fagerås M, Müllerová H, Veeranki PS, Alves JA, Germack HD, Barnes TL, McCormack MC
Format: Article
Language:English
Published: Dove Medical Press 2025-06-01
Series:International Journal of COPD
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Online Access:https://www.dovepress.com/characteristics-and-outcomes-of-people-with-copd-who-experience-exacer-peer-reviewed-fulltext-article-COPD
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author Nordon C
Carstens D
Fagerås M
Müllerová H
Veeranki PS
Alves JA
Germack HD
Barnes TL
McCormack MC
author_facet Nordon C
Carstens D
Fagerås M
Müllerová H
Veeranki PS
Alves JA
Germack HD
Barnes TL
McCormack MC
author_sort Nordon C
collection DOAJ
description Clementine Nordon,1 Donna Carstens,2 Malin Fagerås,3 Hana Müllerová,1 Phani S Veeranki,4 João André Alves,3 Hayley D Germack,2 Timothy L Barnes,4 Meredith C McCormack5 1Respiratory Evidence Strategy, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK; 2US Medical Evidence, Biopharmaceuticals, AstraZeneca, Wilmington, DE, USA; 3Global Medical, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden; 4Value & Evidence Solutions, Optum Life Sciences, Eden Prairie, MN, USA; 5School of Medicine, Johns Hopkins Medicine, Baltimore, MA, USACorrespondence: Hana Müllerová, AstraZeneca UK, Academy House, 136 Hills Road, Cambridge, CB2 8PA, UK, Email hana.muellerova@astrazeneca.comPurpose: Many people with chronic obstructive pulmonary disease (COPD) continue to experience frequent moderate/severe exacerbations despite treatment with inhaled triple therapy (TT). We evaluated the baseline characteristics and outcomes (exacerbation rate, mortality, and healthcare resource utilization [HCRU]) of this COPD population, overall and by smoking status.Patients and methods: A retrospective real-world cohort study of US patients was conducted using Optum’s deidentified Market Clarity Data, an integrated claims and electronic health record database (study period: 2015– 2019). Patients eligible for inclusion were aged ≥ 40 years, with a COPD diagnosis, continuous 12-month (baseline) period of treatment with TT, and record of ≥ 2 moderate or ≥ 1 severe exacerbation during baseline. Follow-up was either variable (from end of baseline to death, loss to follow-up, or end of 2019) or fixed (12 months). Baseline characteristics and treatment patterns, crude incidence rates (IRs) for exacerbations and mortality (per 100 person-years [PYs]; variable follow-up), and HCRU and costs (12-month follow-up) were summarized descriptively.Results: Of 4,920 patients in the TT cohort, mean (SD) age was 62.3 (9.7) years, 60.9% were female, and 68.0% were white; 46.5% of TT cohort patients with a history of smoking were current smokers. Hypertension (92.7%), ischemic heart disease (52.1%), and heart failure (40.1%) were the most prevalent cardiovascular comorbidities. Most patients received oral corticosteroids (89.6%) or antibiotics (92.8%) for exacerbation management during baseline. Add-on therapies included phosphodiesterase-4 inhibitors (10.4%) and leukotriene receptor antagonists (26.4%). During follow-up, IRs (95% CI) were 108.2 (104.7– 111.8) per 100 PY for any moderate/severe exacerbation and 8.0 (7.4– 8.6) per 100 PY for mortality. Exacerbation risk was similar by smoking status. During the 12-month follow-up, mean (SD) all-cause and COPD costs were $63,178 ($77,061) and $26,153 ($47,085), respectively.Conclusion: There is high mortality and considerable HCRU and healthcare costs incurred by people with COPD experiencing frequent moderate/severe exacerbations while on TT. Optimization of COPD management and new therapies are needed to reduce disease burden in this population.Keywords: COPD, burden of illness, exacerbation, inhaled triple therapy, mortality, healthcare resource utilization
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series International Journal of COPD
spelling doaj-art-1a5d0b08ec394e67a16428f8cb00e53f2025-08-20T03:29:52ZengDove Medical PressInternational Journal of COPD1178-20052025-06-01Volume 20Issue 118511864103770Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)Nordon C0Carstens D1Fagerås M2Müllerová H3Veeranki PS4Alves JA5Germack HD6Barnes TL7McCormack MC8Respiratory Evidence Strategy, BioPharmaceuticals MedicalUS Medical Affairs, BioPharmaceuticalsGlobal Medical, BioPharmaceuticals MedicalMedical Evidence, BioPharmaceuticals MedicalValue & Evidence SolutionsGlobal Medical, BioPharmaceuticals MedicalUS Medical Evidence, BioPharmaceuticalsValue & Evidence SolutionsSchool of MedicineClementine Nordon,1 Donna Carstens,2 Malin Fagerås,3 Hana Müllerová,1 Phani S Veeranki,4 João André Alves,3 Hayley D Germack,2 Timothy L Barnes,4 Meredith C McCormack5 1Respiratory Evidence Strategy, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK; 2US Medical Evidence, Biopharmaceuticals, AstraZeneca, Wilmington, DE, USA; 3Global Medical, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden; 4Value & Evidence Solutions, Optum Life Sciences, Eden Prairie, MN, USA; 5School of Medicine, Johns Hopkins Medicine, Baltimore, MA, USACorrespondence: Hana Müllerová, AstraZeneca UK, Academy House, 136 Hills Road, Cambridge, CB2 8PA, UK, Email hana.muellerova@astrazeneca.comPurpose: Many people with chronic obstructive pulmonary disease (COPD) continue to experience frequent moderate/severe exacerbations despite treatment with inhaled triple therapy (TT). We evaluated the baseline characteristics and outcomes (exacerbation rate, mortality, and healthcare resource utilization [HCRU]) of this COPD population, overall and by smoking status.Patients and methods: A retrospective real-world cohort study of US patients was conducted using Optum’s deidentified Market Clarity Data, an integrated claims and electronic health record database (study period: 2015– 2019). Patients eligible for inclusion were aged ≥ 40 years, with a COPD diagnosis, continuous 12-month (baseline) period of treatment with TT, and record of ≥ 2 moderate or ≥ 1 severe exacerbation during baseline. Follow-up was either variable (from end of baseline to death, loss to follow-up, or end of 2019) or fixed (12 months). Baseline characteristics and treatment patterns, crude incidence rates (IRs) for exacerbations and mortality (per 100 person-years [PYs]; variable follow-up), and HCRU and costs (12-month follow-up) were summarized descriptively.Results: Of 4,920 patients in the TT cohort, mean (SD) age was 62.3 (9.7) years, 60.9% were female, and 68.0% were white; 46.5% of TT cohort patients with a history of smoking were current smokers. Hypertension (92.7%), ischemic heart disease (52.1%), and heart failure (40.1%) were the most prevalent cardiovascular comorbidities. Most patients received oral corticosteroids (89.6%) or antibiotics (92.8%) for exacerbation management during baseline. Add-on therapies included phosphodiesterase-4 inhibitors (10.4%) and leukotriene receptor antagonists (26.4%). During follow-up, IRs (95% CI) were 108.2 (104.7– 111.8) per 100 PY for any moderate/severe exacerbation and 8.0 (7.4– 8.6) per 100 PY for mortality. Exacerbation risk was similar by smoking status. During the 12-month follow-up, mean (SD) all-cause and COPD costs were $63,178 ($77,061) and $26,153 ($47,085), respectively.Conclusion: There is high mortality and considerable HCRU and healthcare costs incurred by people with COPD experiencing frequent moderate/severe exacerbations while on TT. Optimization of COPD management and new therapies are needed to reduce disease burden in this population.Keywords: COPD, burden of illness, exacerbation, inhaled triple therapy, mortality, healthcare resource utilizationhttps://www.dovepress.com/characteristics-and-outcomes-of-people-with-copd-who-experience-exacer-peer-reviewed-fulltext-article-COPDCOPDburden of illnessexacerbationinhaled triple therapymortalityhealthcare resource utilization
spellingShingle Nordon C
Carstens D
Fagerås M
Müllerová H
Veeranki PS
Alves JA
Germack HD
Barnes TL
McCormack MC
Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)
International Journal of COPD
COPD
burden of illness
exacerbation
inhaled triple therapy
mortality
healthcare resource utilization
title Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)
title_full Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)
title_fullStr Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)
title_full_unstemmed Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)
title_short Characteristics and Outcomes of People With COPD Who Experience Exacerbations While on Inhaled Triple Therapy: Results of the SIRIUS I Cohort Study in the US (2015–2019)
title_sort characteristics and outcomes of people with copd who experience exacerbations while on inhaled triple therapy results of the sirius i cohort study in the us 2015 amp ndash 2019
topic COPD
burden of illness
exacerbation
inhaled triple therapy
mortality
healthcare resource utilization
url https://www.dovepress.com/characteristics-and-outcomes-of-people-with-copd-who-experience-exacer-peer-reviewed-fulltext-article-COPD
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