Occurrence of Exacerbations and Mortality in High-Risk Chronic Obstructive Pulmonary Disease Patients While on Treatment With Dual or Triple Inhaled Therapy: Results From the SIRIUS Observational Study in the US
Author(s)
Josefine Persson, PhD1, Mike Pollack, MS2, Hayley D. Germack, MS, RN, PhD2, Malin Fageras, PhD1, Timothy L. Barnes, MBA, MPH, PhD3, Meredith C. McCormack, MD4.
1AstraZeneca, Gothenburg, Sweden, 2AstraZeneca, Wilmington, DE, USA, 3Optum Life Sciences, Minneapolis, MN, USA, 4Johns Hopkins School of Medicine, Baltimore, MD, USA.
1AstraZeneca, Gothenburg, Sweden, 2AstraZeneca, Wilmington, DE, USA, 3Optum Life Sciences, Minneapolis, MN, USA, 4Johns Hopkins School of Medicine, Baltimore, MD, USA.
OBJECTIVES: To evaluate the 3-year occurrence of chronic obstructive pulmonary disease (COPD) exacerbations and mortality among high-risk COPD patients while on dual or triple inhaled maintenance therapy.
METHODS: We conducted a retrospective cohort study using Optum’s deidentified Market Clarity Data (2015-2019). Subjects aged ≥40 years with a COPD diagnosis were included. The index date started after the following criteria were met: patients had (1) a continuous 12-month baseline period of treatment with dual/triple maintenance inhalers between 2016-2018; (2) evidence of either ≥2 moderate or ≥1 severe exacerbation during that baseline period. Moderate exacerbations required an emergency department or outpatient visit with a primary COPD diagnosis and steroid or antibiotic prescription within ±7 days; severe exacerbations involved an overnight hospital admission. Exacerbations and all-cause mortality were analyzed using the Kaplan-Meier method.
RESULTS: A total of 16,968 subjects were identified; mean (SD) age was 62.56 (10.15) years, 63% were female, and mean (SD) follow-up was 20.42 (12.18) months. At index, 29% and 71% were on triple and dual therapy, respectively. Among patients with ≥2 moderate exacerbations at index, the probabilities of moderate exacerbations in years 1, 2, and 3 were 0.64, 0.78, and 0.85, respectively; the probabilities of severe exacerbations were 0.13, 0.22, and 0.30, respectively. For patients with ≥1 severe exacerbations at index, probabilities were 0.47, 0.61, and 0.69 for moderate exacerbations, and 0.34, 0.48, and 0.56 for severe exacerbations over the three years. The 3-year mortality was higher among patients with severe exacerbations (26.9%) than moderate exacerbations (13.7%).
CONCLUSIONS: COPD patients with a history of exacerbations while on dual or triple inhaled therapy remain at significant risk of future exacerbations and mortality. This underscores the necessity for innovative therapeutic approaches and targeted interventions to reduce events and improve patient outcomes, thereby reducing the overall burden associated with COPD.
METHODS: We conducted a retrospective cohort study using Optum’s deidentified Market Clarity Data (2015-2019). Subjects aged ≥40 years with a COPD diagnosis were included. The index date started after the following criteria were met: patients had (1) a continuous 12-month baseline period of treatment with dual/triple maintenance inhalers between 2016-2018; (2) evidence of either ≥2 moderate or ≥1 severe exacerbation during that baseline period. Moderate exacerbations required an emergency department or outpatient visit with a primary COPD diagnosis and steroid or antibiotic prescription within ±7 days; severe exacerbations involved an overnight hospital admission. Exacerbations and all-cause mortality were analyzed using the Kaplan-Meier method.
RESULTS: A total of 16,968 subjects were identified; mean (SD) age was 62.56 (10.15) years, 63% were female, and mean (SD) follow-up was 20.42 (12.18) months. At index, 29% and 71% were on triple and dual therapy, respectively. Among patients with ≥2 moderate exacerbations at index, the probabilities of moderate exacerbations in years 1, 2, and 3 were 0.64, 0.78, and 0.85, respectively; the probabilities of severe exacerbations were 0.13, 0.22, and 0.30, respectively. For patients with ≥1 severe exacerbations at index, probabilities were 0.47, 0.61, and 0.69 for moderate exacerbations, and 0.34, 0.48, and 0.56 for severe exacerbations over the three years. The 3-year mortality was higher among patients with severe exacerbations (26.9%) than moderate exacerbations (13.7%).
CONCLUSIONS: COPD patients with a history of exacerbations while on dual or triple inhaled therapy remain at significant risk of future exacerbations and mortality. This underscores the necessity for innovative therapeutic approaches and targeted interventions to reduce events and improve patient outcomes, thereby reducing the overall burden associated with COPD.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
SA73
Topic
Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)