Exacerbation benefit by blood eosinophil counts with budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) at two ICS dose levels in the ETHOS trial: a subgroup analysis

Background: For patients who experience COPD exacerbations on LAMA/LABA, GOLD recommends step-up to ICS/LAMA/LABA triple therapy for those with blood eosinophil counts (EOS) ≥ 100 cells/mm³. In the 52-week ETHOS trial (NCT02465567), triple therapy with BGF MDI at two ICS dose levels reduced the rate of moderate/severe COPD exacerbations vs. dual therapies.

Objective: To assess exacerbation rates in patients with EOS < 100 and ≥ 100 cells/mm³ in ETHOS.

Methods: Patients with moderate-to-very severe COPD and ≥ 1 moderate/severe exacerbation in the prior year were randomised to BGF MDI 320/14.4/10 µg or 160/14.4/10 µg, glycopyrronium/formoterol (GFF) MDI 14.4/10 µg or budesonide/formoterol (BFF) MDI 320/10 µg (all treatments administered twice-daily in a single Aerosphere inhaler).

Results: In the modified ITT population (n = 8509), 82.6% of patients had EOS ≥ 100. In these patients, both doses of BGF MDI reduced moderate/severe exacerbations vs. GFF MDI (by 28 – 29%, both p < 0.0001) and BFF MDI (by 11 – 12%, both p < 0.03; Table). In patients with EOS < 100, both BGF MDI doses reduced exacerbations vs. BFF MDI (p < 0.04) but not vs. GFF MDI.

Conclusions: BGF MDI reduced exacerbations vs. GFF MDI and BFF MDI in patients with EOS ≥ 100 but only vs. BFF MDI in EOS < 100, suggesting this cut-off may be a useful guide for step-up from LAMA/LABA to triple therapy.

Publication History

Article published online:
30 April 2021