Progression from GOLD A/B to GOLD E: a claims analysis of patients with COPD newly initiating inhaled therapy

Abstract Background Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with substantial morbidity and mortality. Acute COPD exacerbations are a primary driver of significant burden and contribute to disease progression. Methods This retrospective, observational cohort study used the Optum Clinformatics® Data Mart database to identify patients with COPD who were classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) A/B0 or A/B1 based on exacerbation history (i.e., they had either 0 [GOLD A/B0] or 1 [GOLD A/B1] moderate exacerbation and 0 severe exacerbations in a 12-month baseline period). Patients were required to be aged ≥ 40 years and to have newly initiated inhaled maintenance therapy for COPD from January 2016 to June 2023. The rates of and time to progression to GOLD E (defined in the claims data as experiencing 2 moderate exacerbations within a 12-month period or 1 severe exacerbation) were estimated using the Kaplain-Meier method. Predictors of progression to GOLD E were analyzed using multivariable Cox proportional hazard models. Results Of the 156,462 included patients, the largest proportion of patients (46.6%) were initiated on long-acting beta-agonists/inhaled corticosteroids. The majority of patients progressed to GOLD E over 5 years. The risk of progressing to GOLD E was approximately 3 times higher in the GOLD A/B1 versus GOLD A/B0 group (hazard ratio [HR] 2.92; 95% CI 2.84–3.00; P < 0.001). The strongest predictor of progressing to GOLD E was history of having a moderate exacerbation. Other independent predictors included older age, having Medicare versus commercial insurance, and the presence of Elixhauser comorbidities. Conclusions Despite use of inhaled maintenance treatments for COPD, most patients still progressed to a frequent or severe exacerbator phenotype. New therapies are needed to modify the disease trajectory in COPD.