Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy

The efficacy of omalizumab has been extensively investigated in clinical trials in patients with severe persistent allergic (pre-treatment total immunoglobulin E 30–700 IU·mL–1) asthma including the Investigation of Omalizumab in Severe Asthma Treatment (INNOVATE) study, which enrolled patients with...

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Main Author: R. Buhl
Format: Article
Language:English
Published: European Respiratory Society 2007-09-01
Series:European Respiratory Review
Subjects:
Online Access:http://err.ersjournals.com/cgi/content/full/16/104/73
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author R. Buhl
author_facet R. Buhl
author_sort R. Buhl
collection DOAJ
description The efficacy of omalizumab has been extensively investigated in clinical trials in patients with severe persistent allergic (pre-treatment total immunoglobulin E 30–700 IU·mL–1) asthma including the Investigation of Omalizumab in Severe Asthma Treatment (INNOVATE) study, which enrolled patients with inadequately controlled severe persistent allergic asthma despite receiving high-dose inhaled corticosteroid in combination with a long-acting beta2-agonist, and also additional controller medication if required. In the INNOVATE study, add-on omalizumab significantly reduced clinically significant exacerbation rates by 26% (0.68 versus 0.91), severe exacerbation rates by 50% (0.24 versus 0.48) and emergency visit rates by 44% (0.24 versus 0.43) and significantly improved asthma-related quality of life (QoL) compared with placebo. In a pooled analysis of data from seven studies, add-on omalizumab significantly reduced asthma exacerbation rates by 38% (0.91 versus 1.47) and total emergency visits by 47% (0.332 versus 0.623). In addition, omalizumab significantly improved QoL versus current asthma therapy in a pooled analysis of data from six studies. Omalizumab has demonstrated a good safety and tolerability profile in completed phase-I, -II and -III studies involving >7,500 patients with asthma, rhinitis or related conditions. Omalizumab represents a major advance for the treatment of severe persistent allergic asthma that is inadequately controlled despite treatment with inhaled corticosteroids and a long-acting beta2-agonist.
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spelling doaj.art-913c90e601c7493180a90374bfc2d0d02022-12-22T03:32:56ZengEuropean Respiratory SocietyEuropean Respiratory Review0905-91801600-06172007-09-01161047377Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapyR. BuhlThe efficacy of omalizumab has been extensively investigated in clinical trials in patients with severe persistent allergic (pre-treatment total immunoglobulin E 30–700 IU·mL–1) asthma including the Investigation of Omalizumab in Severe Asthma Treatment (INNOVATE) study, which enrolled patients with inadequately controlled severe persistent allergic asthma despite receiving high-dose inhaled corticosteroid in combination with a long-acting beta2-agonist, and also additional controller medication if required. In the INNOVATE study, add-on omalizumab significantly reduced clinically significant exacerbation rates by 26% (0.68 versus 0.91), severe exacerbation rates by 50% (0.24 versus 0.48) and emergency visit rates by 44% (0.24 versus 0.43) and significantly improved asthma-related quality of life (QoL) compared with placebo. In a pooled analysis of data from seven studies, add-on omalizumab significantly reduced asthma exacerbation rates by 38% (0.91 versus 1.47) and total emergency visits by 47% (0.332 versus 0.623). In addition, omalizumab significantly improved QoL versus current asthma therapy in a pooled analysis of data from six studies. Omalizumab has demonstrated a good safety and tolerability profile in completed phase-I, -II and -III studies involving >7,500 patients with asthma, rhinitis or related conditions. Omalizumab represents a major advance for the treatment of severe persistent allergic asthma that is inadequately controlled despite treatment with inhaled corticosteroids and a long-acting beta2-agonist.http://err.ersjournals.com/cgi/content/full/16/104/73Allergyanti-immunoglobulin Easthmaexacerbationomalizumabtherapy
spellingShingle R. Buhl
Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy
European Respiratory Review
Allergy
anti-immunoglobulin E
asthma
exacerbation
omalizumab
therapy
title Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy
title_full Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy
title_fullStr Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy
title_full_unstemmed Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy
title_short Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy
title_sort anti ige lessons from clinical trials in patients with severe allergic asthma symptomatic despite optimised therapy
topic Allergy
anti-immunoglobulin E
asthma
exacerbation
omalizumab
therapy
url http://err.ersjournals.com/cgi/content/full/16/104/73
work_keys_str_mv AT rbuhl antiigelessonsfromclinicaltrialsinpatientswithsevereallergicasthmasymptomaticdespiteoptimisedtherapy