Halpin, DMG; Dransfield, MT; Han, MK; Jones, CE; Kilbride, S; Lange, P; Lipson, DA; ... Criner, GJ; + view all Halpin, DMG; Dransfield, MT; Han, MK; Jones, CE; Kilbride, S; Lange, P; Lipson, DA; Lomas, DA; Martinez, FJ; Pascoe, S; Singh, D; Wise, R; Criner, GJ; - view fewer (2020) The Effect of Exacerbation History on Outcomes in the IMPACT Trial. European Respiratory Journal , 55 , Article 1901921. 10.1183/13993003.01921-2019.

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Abstract

IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations.Subgroup analyses assessed whether the efficacy of FF/UMEC/VI versus FF/VI or UMEC/VI, and UMEC/VI versus FF/VI, varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 [30%]), frequent moderate (≥2 moderate/no severe; n=4628 [45%]) and severe (≥1 severe/any moderate; n=2671 [26%]). Endpoints included annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function, and health status (both post hoc).Moderate/severe exacerbation rates were reduced in the FF/UMEC/VI group versus FF/VI (% reduction [95% confidence interval]: single moderate: 20% [10-29]; frequent moderate: 11% [2-19]; severe: 17% [7-26]) and versus UMEC/VI (single moderate: 18% [5-29]; frequent moderate: 29% [21-37]; severe: 26% [14-35]). Moderate/severe exacerbation rates were reduced in the FF/VI group versus UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate: 2% [-12-18]; frequent moderate: 21% [11-29]; severe: 11% [-3-22]). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status versus both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function versus FF/VI in all subgroups.Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.Funding: GSK (CTT116855/NCT02164513).

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