Abstract
Background: Fluticasone furoate (FF)/vilanterol (VI) reduces COPD exacerbations when compared with treatment with VI alone. There is a need for a simple biomarker to allow targeted treatment.
Objective: To compare exacerbation rates between FF/VI and VI in patients with moderate to very severe COPD, stratified by blood eosinophil level.
Methods: We evaluated the use of blood eosinophil count through post-hoc analysis of pooled data from two randomised, double-blind, placebo-controlled 1-year trials (Dransfield MT et al, Lancet Resp Med 2013;1:210–23) comparing FF/VI (50/25mcg, 100/25mcg or 200/25mcg once daily) to VI (25mcg once daily) in patients with COPD and a history of exacerbations in the last year. We evaluated the FF-related reduction in exacerbation rates in patients with eosinophil counts <2% and ≥2%.
Results: 3177 patients provided blood samples at study entry; 2083 (66%) had eosinophils ≥2%. Exacerbation rates were higher in the subgroup treated with VI alone (1.28 vs 0.91/patient/yr). Baseline eosinophil count was significantly associated with reduced exacerbation rates with the three doses of FF/VI combined. Exacerbations were reduced by 29% (p<0.001) in patients with eosinophils ≥2% and 10% (p=0.283) in those with <2%. Treatment differential increased with increasing FF dose. In patients with eosinophils ≥2% receiving FF/VI 50/25mcg, 100/25mcg and 200/25mcg, exacerbations reductions were, respectively: 21%, 33%, 33% (all p<0.01). For eosinophils <2%, the corresponding reductions were 9%, 18%, 3%.
Conclusion: Blood eosinophil level is a promising biomarker of response for ICS treatment in patients with COPD.
Funding: GSK (HZC102871 [NCT01009463] and HZC102970 [NCT01017952])
- © 2014 ERS