RT Journal Article
SR Electronic
T1 Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1352
OP 1359
DO 10.1183/09031936.00063510
VO 37
IS 6
A1 S.T. Holgate
A1 M. Noonan
A1 P. Chanez
A1 W. Busse
A1 L. Dupont
A1 I. Pavord
A1 A. Hakulinen
A1 L. Paolozzi
A1 J. Wajdula
A1 C. Zang
A1 H. Nelson
A1 D. Raible
YR 2011
UL http://erj.ersjournals.com/content/37/6/1352.abstract
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.