Inhaled Corticosteroid-Related Tuberculosis in the Real World Among Patients with Asthma and COPD: A 10-Year Nationwide Population-Based Study

Abstract

Background: There have been concerns about the risk of inhaled corticosteroid (ICS)-related tuberculosis (TB) development.

Objective: We investigated the occurrence of TB among ICS users according to underlying respiratory diseases and type of ICS.

Methods: A 12-year population cohort comprising approximately 1 million subjects collected from the Korean claims database were used. Adult ICS users (budesonide or fluticasone) were enrolled. The temporal relationship between TB development and the last ICS prescription before TB development was evaluated. A nested case-control study was performed with 1:4 matching for age, sex, and the initiation date of the ICS.

Results: There were 17,991 ICS users, and 175 developed TB during the study period. Approximately 80% (140/175) of patients who developed TB were diagnosed within 3 years after the last ICS prescription. In the nested case-control study, the occurrence of TB was not related to the type of ICS, but was related to a higher annual admission rate and a higher comorbidity score. The risk of TB was higher in patients with chronic obstructive pulmonary disease (COPD) than in those with asthma (odds ratio: 2.31; CI 95%: 1.39-3.38; P = .0011) after adjusting for covariates. The subgroup analysis revealed no difference between budesonide and fluticasone with respect to the risk of developing TB in patients with asthma, COPD, or asthma-COPD overlap syndrome.

Conclusion: An increased risk of TB development may persist for 3 years after stopping the ICS and the risk is higher in patients with COPD regardless of the type of ICS used.

Keywords: Asthma; Budesonide; COPD; Fluticasone; Tuberculosis.