Triple therapy (TT) is associated with a decreased risk of moderate/severe exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a blood eosinophil count (EC) of at least 300 cells/µL, according to study results presented at the American College of Chest Physicians (CHEST) 2022 Annual Meeting, held from October 16 to 19, 2022, in Nashville, Tennessee.
Previous real-world research has shown that at least 55% of COPD patients receive inhaled corticosteroids as first-line therapy, even though such therapy has been recommended only for those with a history of exacerbations, asthma, or high blood EC (≥300 cells/µL).
Investigators for the current study assessed the value of triple therapy for patients with and without elevated blood eosinophil counts (EC ≥300 cells/µL vs <300 cells/µL) using data from the AIRWISE trial (ClinicalTrials.gov Identifier: NCT03265145) — a study comparing the real-world efficacy and safety of tiotropium/olodaterol (T/O) vs TT for COPD that was terminated early due slow recruitment. The AIRWISE trial included patients at least 40 years of age with uncontrolled COPD who received long-acting muscarinic antagonist, long-acting β2-agonist (LABA), or inhaled corticosteroid/LABA maintenance therapy from September 2017 to September 2020. The participants were randomized 1:1 to T/O or TT and were followed for 12 months.
The AIRWISE trial’s primary endpoint was the time to the first moderate/severe COPD exacerbation; the secondary endpoint was the annual rate of moderate/severe exacerbations. In the current post hoc subgroup analysis of AIRWISE data, investigators assessed these endpoints for patients with blood EC of less than 300 cells/µL vs those with an EC of 300 cells/µL or more.
A total of 714 patients were randomly assigned to the T/O group (n=356) and the TT group (n=358). The overall mean [SD] age of the cohort was 69.5 [9.6] years and 49.7% were men; in the previous 12 months, 49.4% of patients had at least 1 moderate exacerbation and 16.9% had at least 1 severe exacerbation. Of the cohort, 509 (71.3%) patients had an EC of less than 300 cells/µL, 175 (24.5%) had an EC of 300 cells/µL or more, and 30 (4.2%) had no baseline EC data.
The time to the first moderate/severe exacerbation of COPD was comparable between the treatments for participants who had a baseline EC of less than 300 cells/µL (hazard ratio [HR], 1.02; 95% CI, 0.68-1.53). A HR that was favorable for TT was found only in patients who had an EC of 300 cells/µL or more (HR, 2.16; 95% CI, 1.12-4.16).
The results were similar regarding the annual rate of moderate/severe exacerbations (relative risk, 1.12; 95% CI, 0.71-1.76) for an EC of less than 300 cells/µL and 2.70 (95% CI, 1.36-5.36) for an EC of 300 cells/µL or more.
The researchers concluded that “TT initiation in patients with COPD should be determined by the patient’s phenotype as it may be more beneficial in reducing exacerbation risk in patients with an EC ≥300 cells/µL (inflammatory/allergic component).”
Disclosure: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Mina BA, Averill F, Shaikh A, et al. Exacerbation risk in COPD patients based on eosinophil count: post hoc analysis of the randomized pragmatic trial, AIRWISE, comparing tiotropium/olodaterol with triple therapy. Abstract presented at: CHEST 2022 Annual Meeting; October 16-19, 2022; Nashville, TN.