Clinical and economic impact of inhaled corticosteroid withdrawal in Spanish COPD patients treated with triple therapy

Abstract

<b>Background and aim:</b> Determine the clinical and economic impact of inhaled corticosteroid (ICS) withdrawal in Spanish COPD patients receiving treatment with triple therapy (TT). <b>Methods:</b> An observational retrospective study using electronic medical records from BIG-PAC Spanish database. Patients aged ≥40 years receiving TT during 2016–2018 were followed for 1 year. Two cohorts were identified: continuous TT (ICS+LABA+LAMA), and ICS withdrawal (LABA+LAMA). Outcomes assessed included medication, exacerbations, pneumonia, mortality, health resource use and cost/patient-year. Cohorts were compared using Propensity Score Matching (PSM) and multi-variate statistical analysis. <b>Results:</b> 5740 (87.8%) patients continued TT, while the ICS component was withdrawn in 801 (12.2%). Patients with ICS withdrawal had lower age and disease burden, higher ICS doses and less exacerbations. After PSM, 795 patients in each study cohort were matched. The mean age was 68.4 (SD: 11.2) years, 69.9% male, and the mean Charlson index was 2.0. Patients with ICS withdrawal had more total exacerbations (36.6% vs 31.4%; p=0.030). No significant differences were found between groups for pneumonia (3.3% vs 3.6%; p=0.583) and mortality (9.9% vs 7.5%; p=0.092). The hazard ratio for time to first exacerbation of TT vs ICS withdrawal was 0.69 (95% CI: 0.57–0.83; p&lt;0.001). The mean health cost per patient-year with ICS withdrawal was higher (€2993 vs €2130; p&lt;0.001). <b>Conclusions:</b> ICS withdrawal in TT patients was associated with more exacerbations, increasing health resource use and costs for the National Health System. Pneumonia and mortality rates were similar between groups. <b>Funding:</b> GSK (study 213389)