Efficacy/safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial

Holgate, S.T., Noonan, M., Chanez, P., Busse, W., Dupont, L., Pavord, I., Hakulinen, A., Paolozzi, L., Wajdula, J., Zang, C., Nelson, H. and Raible, D. (2010) Efficacy/safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial European Respiratory Journal, 37, (6), pp. 1352-1359. (doi:10.1183/09031936.00063510). (PMID:21109557).


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Increased tumour necrosis factor (TNF)-? 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.

Item Type: Article
Digital Object Identifier (DOI): doi:10.1183/09031936.00063510
ISSNs: 0903-1936 (print)
Keywords: asthma, etanercept, forced expiratory volume

ePrint ID: 183177
Date :
Date Event
25 November 2010e-pub ahead of print
June 2011Published
Date Deposited: 28 Apr 2011 14:43
Last Modified: 18 Apr 2017 02:23
Further Information:Google Scholar
URI: http://eprints.soton.ac.uk/id/eprint/183177

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