PT - JOURNAL ARTICLE AU - S.T. Holgate AU - M. Noonan AU - P. Chanez AU - W. Busse AU - L. Dupont AU - I. Pavord AU - A. Hakulinen AU - L. Paolozzi AU - J. Wajdula AU - C. Zang AU - H. Nelson AU - D. Raible TI - Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial AID - 10.1183/09031936.00063510 DP - 2011 Jun 01 TA - European Respiratory Journal PG - 1352--1359 VI - 37 IP - 6 4099 - http://erj.ersjournals.com/content/37/6/1352.short 4100 - http://erj.ersjournals.com/content/37/6/1352.full SO - Eur Respir J2011 Jun 01; 37 AB - Increased tumour necrosis factor-α levels have been observed in bronchial biopsies and induced sputum from subjects with severe asthma. We investigated etanercept (ETN) as a therapeutic option for treating moderate-to-severe persistent asthma. In this 12-week, randomised, double-blind, placebo-controlled, phase 2 trial, subjects (n = 132) with moderate-to-severe persistent asthma received subcutaneous injections of 25 mg ETN or placebo twice weekly, and were evaluated at baseline, and at weeks 2, 4, 8 and 12. The primary end-point was the change from baseline to week 12 in pre-bronchodilator forced expiratory volume in 1 s (FEV1) % predicted. Secondary end-points included morning peak expiratory flow, FEV1 % pred, Asthma Control Questionnaire (5-item version), asthma exacerbations, provocative concentration of methacholine causing a 20% decrease in FEV1, and the Asthma Quality of Life Questionnaire. No significant differences were observed between ETN and placebo for any of the efficacy end-points. ETN treatment was well tolerated, with no unexpected safety findings observed during the study. Clinical efficacy of ETN was not shown in subjects with moderate-to-severe persistent asthma over 12 weeks. However, ETN treatment was a well-tolerated therapy. Studies in specific subsets of patients with asthma with longer-term follow-up may be needed to fully evaluate the clinical efficacy of ETN in this population.