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. (2011) Efficacy/safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. European Respiratory Journal, 37, (6), 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.
|Digital Object Identifier (DOI):||doi:10.1183/09031936.00063510|
|Keywords:||asthma, etanercept, forced expiratory volume|
|Subjects:||R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
R Medicine > RF Otorhinolaryngology
R Medicine > RM Therapeutics. Pharmacology
|Divisions :||University Structure - Pre August 2011 > School of Medicine > Infection, Inflammation and Repair
|Accepted Date and Publication Date:||
|Date Deposited:||28 Apr 2011 14:43|
|Last Modified:||31 Mar 2016 13:37|
|RDF:||RDF+N-Triples, RDF+N3, RDF+XML, Browse.|
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