Pneumonia risk with budesonide-containing therapies in COPD: pooled analysis of three Phase III studies

Objective: To evaluate pneumonia risk in patients with moderate-to-very severe COPD who received budesonide ICS or non-ICS containing therapies. Methods: Safety population data were pooled from 3 Phase III, randomized, double-blind, parallel-group studies: KRONOS (NCT02497001; 24 weeks; N=1896), TELOS (NCT02766608; 24 weeks; N=2361) and SOPHOS (NCT02727660; 12–52 weeks; N=1843). In all studies, pneumonia events were reviewed and confirmed by an external, independent Clinical Endpoint Committee using the same pre-defined criteria. Treatment arms were combined into a budesonide 320 µg group (N=2970), a budesonide 160 µg group (N=1254) and a non-ICS group (N=1876) (Table). Treatment comparisons were performed using a Cox regression model, adjusting for study, post-bronchodilator FEV1 % predicted, baseline age and history of pneumonia in the past 5 years (yes/no) as covariates. Results: In the budesonide 320 µg, budesonide 160 µg and non-ICS groups, 1.4%, 1.8% and 1.8% of patients, respectively, had confirmed pneumonia. The hazard ratios for the time to first confirmed pneumonia for the budesonide 320 µg and budesonide 160 µg groups vs the non-ICS group were 0.80 (95% CI 0.50, 1.26) and 0.88 (95% CI 0.51, 1.51), respectively (Table). Conclusion: In patients with moderate-to-very severe COPD, pneumonia incidence with budesonide-containing therapies was low and was not increased vs non-ICS containing therapies.