Only 58.8% of at-risk COPD patients with a history of frequent or severe exacerbations received any maintenance therapy over a mean follow-up of 24.2 months.
Observational (n=845,882)
Despite guideline recommendations, a large proportion of at-risk COPD patients in the US do not receive appropriate maintenance therapy, highlighting a significant gap in real-world practice.
Abstract Rationale COPD exacerbations are a driver of significant burden, contribute to disease progression, and increase risk for future cardiopulmonary events. GOLD 2025 recommends maintenance treatment with dual (i.e., long-acting beta agonist LABA/long-acting muscarinic antagonist LAMA) or triple (i.e., inhaled corticosteroid ICS/LABA/LAMA) therapy to reduce exacerbation frequency and severity among patients with a history of exacerbations. This study provides a contemporary assessment of maintenance therapy use in this at-risk population in the US. Methods A retrospective analysis of COPD patients ≥40 years old was conducted using the Komodo Research Data (KRD+; 01/01/2021-06/30/2024). The index date was defined as 01/01/2022 or the date of first observed COPD diagnosis if after 01/01/2022, and patients were followed until end of data/enrollment or death. Continuous health insurance enrollment was required for ≥12 months pre-index (i.e., baseline) and ≥6 months post-index, unless death occurred. At-risk patients were those with ≥1 severe exacerbation (i.e., leading to hospitalization) or ≥ 2 moderate exacerbations (i.e., leading to an outpatient or emergency room visit with intravenous theophylline/aminophylline, corticosteroids, or antibiotics treatment) during baseline. Maintenance therapy use and treatment sequences (up to 3 lines of therapy LOT) were assessed during follow-up. LOT regimens were defined based on agents received within the first 30 days; treatment changes were identified as initiation of ≥ 1 new agent or discontinuation of ≥ 1 agent (i.e., ≥90-day gap without supply). Results Among 1,421,278 eligible patients with COPD, 845,882 (59.5%) were at-risk (mean age: 68.3 years; 53.3% female, 67.9% White, 46.4% on Medicare Advantage). Over a mean follow-up of 24.2 months, only 58.8% of at-risk patients received any maintenance therapy (monotherapy: 13.2%, dual therapy: 37.0%, triple therapy: 27.8%). Among patients receiving maintenance therapy, the most commonly observed first LOT was ICS/LABA (40.4%). ICS/LABA was also commonly observed in second (16.1%) and third (6.3%) LOT. Many patients restarted the same treatment in the subsequent LOT following a discontinuation, although substantial proportions did not initiate any new regimen after discontinuing the first (18.2%) and second (26.9%) LOTs. Conclusions Despite experiencing frequent or severe exacerbations, a large proportion of at-risk patients did not receive maintenance therapy. Among those who received maintenance therapy, monotherapy and ICS/LABA remained common, despite GOLD recommending LABA/LAMA or ICS/LABA/LAMA over ICS/LABA since 2023. These findings highlight a gap between real-world practice and guideline-recommend treatment. Further research is needed to understand drivers of underutilization and support optimized maintenance therapy that could meaningfully reduce the burden associated with COPD exacerbations. This abstract is funded by: AstraZeneca
Siddharthan et al. (2026) conducted an observational in Chronic Obstructive Pulmonary Disease (COPD) (n=845,882). Maintenance therapy (monotherapy, dual, or triple therapy) was evaluated on Receipt of any maintenance therapy. Only 58.8% of at-risk COPD patients with a history of frequent or severe exacerbations received any maintenance therapy over a mean follow-up of 24.2 months.