Abstract
Introduction: Studies suggest that high blood EOS count may be a marker of increased exacerbation risk in COPD patients (pts) with a history of exacerbations. We investigated the effect of blood EOS count on the efficacy of roflumilast (ROF) on COPD exacerbation rate.
Methods: A post-hoc analysis was performed on two trials (REACT [NCT01329029], RE2SPOND [NCT01443845]) in which pts with severe COPD and ≥2 exacerbations in the previous year were randomised to ROF 500μg od or placebo (PBO) added to ICS/LABA±LAMA for 52 weeks. Primary endpoint was rate of moderate or severe COPD exacerbations/pt/year. Exacerbation rates were analysed by baseline EOS cell count strata (<150 and ≥150 cells/mm3).
Results: Of 4287 pts, 2146 had an EOS count ≥150 cells/mm3 at entry. ROF reduced moderate or severe exacerbations rates by 19.1% (p=0.002) in pts with EOS ≥150 cells/mm3 and by 3.8% (p=0.605) in pts with EOS <150 cells/mm3 vs PBO (Table). Baseline demographics were balanced across EOS strata, including history of COPD exacerbations and hospitalisation for COPD exacerbation in the year prior.
Conclusions: In this post-hoc analysis, PBO-treated COPD pts with higher blood baseline EOS counts had more exacerbations. Pts with higher blood baseline EOS counts derived greater benefit from ROF in exacerbation risk reduction compared to PBO.
- Copyright ©the authors 2017