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Victoria Neches García,1 Laura Amanda Vallejo-Aparicio,1 Afisi S Ismaila,2,3 Antoni Sicras-Mainar,4 Aram Sicras-Navarro,4 Cruz González,5 Rafael Cuervo,6 Soham Shukla,2 Marcos García-Peñuela6 1Market Access, GlaxoSmithKline, Madrid, Spain; 2Value Evidence and Outcomes, GlaxoSmithKline, Collegeville, PA, USA; 3Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada; 4Real Life Data, Atrys Health, Barcelona, Spain; 5Pneumology Unit, Hospital Clínico Universitario de Valencia, Valencia, Spain; 6Medical Affairs, GlaxoSmithKline, Madrid, SpainCorrespondence: Victoria Neches García, Market Access, GlaxoSmithKline, P.T.M Severo Ochoa, 2 28760 Tres Cantos, Madrid, Spain, Tel +34 677 50 37 57, Email victoria.x.neches@gsk.comPurpose: To determine the clinical and economic impact of inhaled corticosteroid (ICS) withdrawal in Spanish patients with COPD receiving triple therapy (TT) with ICS, long-acting β2-agonist (LABA), and long-acting muscarinic antagonist (LAMA).Patients and Methods: This was an observational, retrospective study of BIG-PAC database medical records. Patients aged ≥ 40 years receiving TT from 2016 to 2018 were followed for 1 year. Two cohorts were identified: patients continuing TT (ICS+LABA+LAMA), and patients receiving TT with ICS withdrawn (LABA+LAMA). Variables included medication, exacerbations (moderate and severe), pneumonia, mortality, health resource use (HRU), and cost per patient/year. Cohorts were compared using propensity score matching (PSM). Multivariate statistical analysis using analysis of covariance and Cox proportional risks was conducted.Results: Of 6541 patients included, 5740 (87.8%) continued TT and 801 (12.2%) had ICS withdrawn. Patients with ICS withdrawal were younger, had lower disease burden, higher ICS doses, and more exacerbations compared with those continuing ICS. PSM matched 795 patients in each cohort. Mean age was 68.5 years (SD: 11.2), 69.9% were male, and mean Charlson index was 2.0. Patients with ICS withdrawal had more total exacerbations in the 12 months following withdrawal compared with patients continuing TT (36.6% vs 31.4%; p=0.030). No significant differences were found for pneumonia (3.3% vs 3.6%; p=0.583) and mortality (9.9% vs 7.5%; p=0.092). Median time to first exacerbation was shorter in patients with ICS withdrawal compared with those continuing ICS (HR: 0.69, 95% CI: 0.57– 0.83; p< 0.001). Mean health cost per patient/year among patients with ICS withdrawal was higher than those continuing TT (€ 2993 vs € 2130; p< 0.001).Conclusion: ICS withdrawal in patients with COPD receiving TT was associated with increased exacerbations, HRU, and costs compared with continuing TT, with health and economic impacts on patients and the Spanish National Healthcare System, respectively. Pneumonia and mortality rates were similar between groups.Keywords: inhaled corticosteroid withdrawal, COPD, exacerbations, resource use, health costs