TNFα antagonists for acute exacerbations of COPD: a randomised double-blind controlled trial
- Shawn D Aaron1,
- Katherine L Vandemheen1,
- François Maltais2,
- Stephen K Field3,
- Don D Sin4,
- Jean Bourbeau5,
- Darcy D Marciniuk6,
- J Mark FitzGerald4,
- Parameswaran Nair7,
- Ranjeeta Mallick1
- 1Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
- 2Centre de Recherche, Institut Universitaire de cardiologie et de pneumologie de Québec, Quebec, Canada
- 3The Department of Medicine, University of Calgary, Calgary, Canada
- 4Department of Medicine, The University of British Columbia, Vancouver, Alberta, Canada
- 5Department of Medicine, McGill University, Montreal, Quebec, Canada
- 6Respiratory Medicine, The Department of Medicine, University of Saskatchewan, Saskatoon, Canada
- 7Department of Medicine, McMaster University, Hamilton, Ontario, Canada
- Correspondence to Dr Shawn D Aaron, Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, General Campus, 501 Smyth Road, Ottawa, Ontario, Canada K1H 8L6;
- Received 16 July 2012
- Revised 14 September 2012
- Accepted 19 October 2012
- Published Online First 17 November 2012
Background The purpose of this randomised double-blind double-dummy placebo-controlled trial was to investigate whether etanercept, a tumour necrosis factor α (TNFα) antagonist, would provide more effective anti-inflammatory treatment for acute exacerbations of chronic obstructive pulmonary disease (COPD) than prednisone.
Methods We enrolled 81 patients with acute exacerbations of COPD and randomly assigned them to treatment with either 40 mg oral prednisone given daily for 10 days or to 50 mg etanercept given subcutaneously at randomisation and 1 week later. Both groups received levofloxacin for 10 days plus inhaled bronchodilators. The primary endpoint was the change in the patient's forced expiratory volume in 1 s (FEV1) 14 days after randomisation. Secondary endpoints included 90-day treatment failure rates and dyspnoea and quality of life.
Results At 14 days the mean±SE change in FEV1 from baseline was 20.1±5.0% and 15.2±5.7% for the prednisone and etanercept groups, respectively. The mean between-treatment difference was 4.9% (95% CI −10.3% to 20.2%), p=0.52. Rates of treatment failure at 90 days were similar in the prednisone and etanercept groups (32% vs 40%, p=0.44), as were measures of dyspnoea and quality of life. Subgroup analysis revealed that patients with serum eosinophils >2% at exacerbation tended to experience fewer treatment failures if treated with prednisone compared with etanercept (22% vs 50%, p=0.08).
Conclusions Etanercept was not more effective than prednisone for treatment of acute exacerbations of COPD. Efficacy of prednisone was most apparent in patients who presented with serum eosinophils >2%.
Clinical Trials gov number NCT 00789997.