Science and Research

Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial

RATIONALE: Post hoc analyses suggest that blood eosinophils have potential as a predictive biomarker of inhaled corticosteroid efficacy in the management of chronic obstructive pulmonary disease (COPD). OBJECTIVES: We prospectively investigated the value of blood eosinophils as a predictor of responsiveness to an inhaled corticosteroid/long-acting beta2-agonist combination versus a long-acting beta2-agonist/long-acting muscarinic antagonist combination for exacerbation prevention. METHODS: We conducted prespecified analyses of data from the FLAME (Effect of Indacaterol Glycopyronium vs Fluticasone Salmeterol on COPD Exacerbations) study, which compared once-daily long-acting beta2-agonist/long-acting muscarinic antagonist indacaterol/glycopyrronium 110/50 mug with twice-daily long-acting beta2-agonist/inhaled corticosteroid salmeterol/fluticasone combination 50/500 mug in patients with one or more exacerbations in the preceding year. Subsequent post hoc analyses were conducted to address further cutoffs and endpoints. MEASUREMENTS AND MAIN RESULTS: We compared treatment efficacy according to blood eosinophil percentage (<2% and >/=2%, <3% and >/=3%, and <5% and >/=5%) and absolute blood eosinophil count (<150 cells/mul, 150 to <300 cells/mul, and >/=300 cells/mul). Indacaterol/glycopyrronium was significantly superior to salmeterol/fluticasone for the prevention of exacerbations (all severities, or moderate or severe) in the <2%, >/=2%, <3%, <5%, and <150 cells/mul subgroups, and at no cutoff was salmeterol/fluticasone superior to indacaterol/glycopyrronium. Furthermore, the rate of moderate or severe exacerbations did not increase with increasing blood eosinophils. The incidence of pneumonia was higher in patients receiving salmeterol/fluticasone than indacaterol/glycopyrronium in both the <2% and >/=2% subgroups. CONCLUSIONS: Our prospective analyses indicate that indacaterol/glycopyrronium provides superior or similar benefits over salmeterol/fluticasone regardless of blood eosinophil levels in patients with COPD. Clinical trial registered with

  • Roche, N.
  • Chapman, K. R.
  • Vogelmeier, C. F.
  • Herth, F. J. F.
  • Thach, C.
  • Fogel, R.
  • Olsson, P.
  • Patalano, F.
  • Banerji, D.
  • Wedzicha, J. A.

Keywords

  • Adrenal Cortex Hormones/administration & dosage/therapeutic use
  • Adrenergic beta-2 Receptor Agonists/administration & dosage/therapeutic use
  • Aged
  • Biomarkers/blood
  • Double-Blind Method
  • Drug Therapy, Combination
  • *Eosinophils/drug effects
  • Female
  • Fluticasone-Salmeterol Drug Combination/therapeutic use
  • Humans
  • Indans/therapeutic use
  • Leukocyte Count
  • Male
  • Middle Aged
  • Pulmonary Disease, Chronic Obstructive/*blood/drug therapy
  • Quinolones/therapeutic use
  • Treatment Outcome
  • *qva149
  • *bronchodilation
  • *chronic obstructive pulmonary disease
  • *exacerbations
  • *inhaled corticosteroids
Publication details
DOI: 10.1164/rccm.201701-0193OC
Journal: Am J Respir Crit Care Med
Pages: 1189-1197 
Number: 9
Work Type: Original
Location: TLRC, UGMLC
Disease Area: COPD
Partner / Member: Thorax, UMR
Access-Number: 28278391
See publication on PubMed

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