Burden, characteristics and outcomes of COPD patients experiencing moderate or severe exacerbations on triple therapy (ANTLIA NOVELTY)

<bold>Background:</bold> Patients with COPD can experience exacerbations while on inhaled triple therapy. <bold>Objective:</bold> To characterize this patient population and their outcomes in the NOVELTY study. <bold>Methods:</bold> Patients with a physician assigned COPD diagnosis from an observational multi-country study (NOVELTY; <ext-link>NCT02760329</ext-link>) were stratified at baseline as having ≥2 moderate or ≥1 severe exacerbation(s) in prior 12 months while on inhaled triple therapy (EXAC+TT); or as not fulfilling either exacerbation and/or triple therapy criteria (nonEXAC and/or nonTT). Adjusted regression models were used to estimate associations with exacerbations, lung function and mortality over 3 years. <bold>Results:</bold> Patients with COPD split into EXAC+TT (484/4674) vs. nonEXAC and/or nonTT (4190/4674) groups, were of similar age (mean: 67 vs 66 yrs) and sex (female: 42% vs 41%). Patients in EXAC+TT vs nonEXAC and/or nonTT group were more likely to be ex-smokers (75% vs 64%), have CV comorbidities (major CVD: 30% vs 23%), worse respiratory symptoms (mMRC dyspnoea grade ≥2: 72% vs 50%; frequent productive cough 51% vs 37%), poorer HRQoL (CAAT mean: 21 vs 17), worse airflow obstruction and higher blood eosinophils ≥300 cells/µl (26% vs 21%). Over 3 years, EXAC+TT (vs non EXAC and/or nonTT) group experienced a higher rate of exacerbations [IRRadj 3.23, 95% CI 2.69, 3.88], and mortality [HRadj 1.69, 95%CI 1.25, 2.28]. No difference was observed for FEV₁ change. <bold>Conclusion:</bold> There is substantially higher morbidity and mortality among patients with COPD with frequent exacerbations while on inhaled TT vs other patients with COPD. This warrants further interventions including potential add-on treatments.