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Reduced risk of clinically important deteriorations by ICS in COPD is eosinophil dependent: a pooled post-hoc analysis

  • Bafadhel, Mona1
  • Singh, Dave2
  • Jenkins, Christine3
  • Peterson, Stefan4
  • Bengtsson, Thomas4
  • Wessman, Peter5
  • Fagerås, Malin5
  • 1 University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK , Oxford (United Kingdom)
  • 2 Manchester University NHS Foundation Trust, University of Manchester, Manchester, UK , Manchester (United Kingdom)
  • 3 The George Institute for Global Health, University of New South Wales, Sydney, Australia , Sydney (Australia)
  • 4 StatMind, Lund, Sweden , Lund (Sweden)
  • 5 AstraZeneca, Gothenburg, Sweden , Gothenburg (Sweden)
Published Article
Respiratory Research
BioMed Central
Publication Date
Jan 10, 2020
DOI: 10.1186/s12931-020-1280-y
Springer Nature


BackgroundClinically Important Deterioration (CID) is a novel composite measure to assess treatment effect in chronic obstructive pulmonary disease (COPD). We examined the performance and utility of CID in assessing the effect of inhaled corticosteroids (ICS) in COPD.MethodsThis post-hoc analysis of four budesonide/formoterol (BUD/FORM) studies comprised 3576 symptomatic moderate-to-very-severe COPD patients with a history of exacerbation. Analysis of time to first CID event (exacerbation, deterioration in forced expiratory volume in 1 second [FEV1] or worsening St George’s Respiratory Questionnaire [SGRQ] score) was completed using Cox proportional hazards models.ResultsThe proportion of patients with ≥1 CID in the four studies ranged between 63 and 77% and 69–84% with BUD/FORM and FORM, respectively, with an average 25% reduced risk of CID with BUD/FORM. All components contributed to the CID event rate. Experiencing a CID during the first 3 months was associated with poorer outcomes (lung function, quality of life, symptoms and reliever use) and increased risk of later CID events. The effect of BUD/FORM versus FORM in reducing CID risk was positively associated with the blood eosinophil count.ConclusionsOur findings suggest that BUD/FORM offers protective effects for CID events compared with FORM alone, with the magnitude of the effect dependent on patients’ eosinophil levels. CID may be an important tool for evaluation of treatment effect in a complex, multifaceted, and progressive disease like COPD, and a valuable tool to allow for shorter and smaller future outcome predictive trials in early drug development.

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