Effect of Inhaled Corticosteroid Withdrawal on Chronic Obstructive Pulmonary Disease Exacerbations in Patients Taking Triple Therapy at Baseline

• Published in: International journal of chronic obstructive pulmonary disease Vol. 15; pp. 2879 - 2888
• Main Authors: Ferguson, Gary T, Shaikh, Asif, Tetzlaff, Kay, Mueller, Achim, Magnussen, Helgo, Watz, Henrik
• Format: Journal Article
• Language: English
• Published: London Dove Medical Press Limited 01.01.2020; Dove Medical Press Ltd; Dove; Dove Medical Press
• Subjects: Analysis; Asthma; Care and treatment; Chronic obstructive pulmonary disease; copd; Corticosteroids; dual bronchodilator; glucocorticoid; Inhalers; Lung diseases, Obstructive; Original Research; Pharmaceutical industry; Population; Steroids; Tiotropium; triple therapy; United States; Germany
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S237408

Purpose: In the Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial, inhaled corticosteroid (ICS) withdrawal in patients with chronic obstructive pulmonary disease receiving triple therapy (long-acting [[beta].sub.2]-agonist+long-acting muscarinic antagonist+ICS) did not change moderate/severe exacerbation risk. However, many patients were not taking triple therapy before study participation. This analysis was conducted to eliminate the impact of non-ICS users on WISDOM results by re-analyzing the data using only the subset of patients who were taking triple therapy at screening. Patients and Methods: The effect of ICS withdrawal on moderate/severe exacerbation risk in the subgroup of WISDOM patients taking triple therapy before enrolling in the study was evaluated in this post hoc analysis. Additionally, the effect of ICS withdrawal in patients with a history of [greater than or equal to]2 exacerbations in the previous year and various blood eosinophil counts was assessed. Results: Overall, 39.0% (n=970: ICS continuation, 479; ICS withdrawal, 491) of the WISDOM trial population were taking triple therapy at screening. Baseline characteristics were generally similar between groups. Moderate/severe exacerbation risk between the ICS withdrawal and continuation groups (hazard ratio [HR], 1.05; 95% confidence interval [CI]: 0.89-1.25) was not increased in patients taking triple therapy at screening versus the overall trial population (HR [95% CI]: 1.06 [0.94-1.19]). However, in patients with a history of [greater than or equal to]2 exacerbations, exacerbation risk (HR [95% CI]) increased nominally with blood eosinophil count from 1.07 [0.81-1.41] ([greater than or equal to]100 cells/[micro]L) to 1.45 [0.58-3.60] ([greater than or equal to]400 cells/[micro]L). Conclusion: Consistent with results from the overall WISDOM trial population, ICS withdrawal did not increase exacerbation risk in patients taking triple therapy at screening. Patients with a history of frequent exacerbations and higher blood eosinophil counts could benefit from continuation of ICS-based therapy. Keywords: COPD, dual bronchodilator, glucocorticoid, triple therapy