TY - JOUR T1 - Efficacy/safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/09031936.00063510 SP - erj00635-2010 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 Y1 - 2010/01/01 UR - http://erj.ersjournals.com/content/early/2010/11/25/09031936.00063510.abstract N2 - Increased tumour necrosis factor (TNF)-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 ETN 25 mg 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 second (FEV1) % predicted. Secondary end-points included morning peak expiratory flow; FEV1 % predicted; Asthma Control Questionnaire; asthma exacerbations; PC20 assessed by methacholine challenge; 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. ER -