Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial.
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-contr...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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2011
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| _version_ | 1797094187671224320 |
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| author | Holgate, S Noonan, M Chanez, P Busse, W Dupont, L Pavord, I Hakulinen, A Paolozzi, L Wajdula, J Zang, C Nelson, H Raible, D |
| author_facet | Holgate, S Noonan, M Chanez, P Busse, W Dupont, L Pavord, I Hakulinen, A Paolozzi, L Wajdula, J Zang, C Nelson, H Raible, D |
| author_sort | Holgate, S |
| collection | OXFORD |
| description | 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. |
| first_indexed | 2024-03-07T04:10:35Z |
| format | Journal article |
| id | oxford-uuid:c7b35146-3717-4052-ab99-b4cadeb00d4c |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T04:10:35Z |
| publishDate | 2011 |
| record_format | dspace |
| spelling | oxford-uuid:c7b35146-3717-4052-ab99-b4cadeb00d4c2022-03-27T06:46:58ZEfficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:c7b35146-3717-4052-ab99-b4cadeb00d4cEnglishSymplectic Elements at Oxford2011Holgate, SNoonan, MChanez, PBusse, WDupont, LPavord, IHakulinen, APaolozzi, LWajdula, JZang, CNelson, HRaible, DIncreased 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. |
| spellingShingle | Holgate, S Noonan, M Chanez, P Busse, W Dupont, L Pavord, I Hakulinen, A Paolozzi, L Wajdula, J Zang, C Nelson, H Raible, D Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. |
| title | Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. |
| title_full | Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. |
| title_fullStr | Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. |
| title_full_unstemmed | Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. |
| title_short | Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. |
| title_sort | efficacy and safety of etanercept in moderate to severe asthma a randomised controlled trial |
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