Clinical burden of disease in COPD patients on double and triple therapy – a retrospective, longitudinal German claims study

<bold>Background:</bold> COPD patients on triple therapy (TT, or double therapy, DT, if ICS is contraindicated) may continue to experience moderate or severe exacerbations. <bold>Objectives:</bold> This claims data analysis was designed to describe the pharmacological treatment and clinical burden of disease in this patient population. <bold>Methods:</bold> Patients diagnosed with COPD initiating TT/DT and aged ≥40 years in 2017, were analyzed from 2014 to 2019 in anonymized claims data. Treatments, including defined daily dose (DDD), across 2-years follow-up, compliance (≥70% proportion of days covered, PDC) as well as number of exacerbations (0, 1, 2, 3, 4+), as defined in GOLD report, were evaluated. <bold>Results:</bold> Of the 3,458,989 insured patients in 2017, 6,769 initiated TT/DT, of these 4,529 (67%) did not experience an exacerbation during the follow-up; 18% had one exacerbation, 7% had two, 3% had three and 5% had four or more. The PDC patient population showed decreased use of antibiotics independent of the number of exacerbations. Azithromycin and roflumilast were prescribed more with increasing follow-up exacerbations; 12% and 1% with no exacerbations, to 18% and 15% with 4+ exacerbations, respectively. Azithromycin mean DDD per patient year was highest in patients with 4+ follow-up exacerbations (10.0 days, SD 42.7), however, roflumilast DDD was highest in patients with one exacerbation (222.9 days, SD 317.0). Between 66% to 71% of patients discontinued roflumilast during follow-up. <bold>Conclusion:</bold> A high proportion of COPD patients treated with TT/DT continue to experience exacerbations, as reflected by prescriptions of azithromycin and roflumilast, indicating a major unmet medical need in this population.