Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma

Abstract Background Omalizumab is approved for treating severe allergic asthma from age 6, but the definition of severe asthma including a systematic assessment to rule out difficult-to-treat asthma has changed since the drug was approved in 2003. Methods We conducted a systematic review and meta-an...

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Main Authors: Daniel P. Henriksen, Uffe Bodtger, Kirsten Sidenius, Niels Maltbaek, Lars Pedersen, Hanne Madsen, Ehm A. Andersson, Ole Norgaard, Louise K. Madsen, Bo L. Chawes
Format: Article
Language:English
Published: BMC 2020-06-01
Series:Allergy, Asthma & Clinical Immunology
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13223-020-00442-0
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author Daniel P. Henriksen
Uffe Bodtger
Kirsten Sidenius
Niels Maltbaek
Lars Pedersen
Hanne Madsen
Ehm A. Andersson
Ole Norgaard
Louise K. Madsen
Bo L. Chawes
author_facet Daniel P. Henriksen
Uffe Bodtger
Kirsten Sidenius
Niels Maltbaek
Lars Pedersen
Hanne Madsen
Ehm A. Andersson
Ole Norgaard
Louise K. Madsen
Bo L. Chawes
author_sort Daniel P. Henriksen
collection DOAJ
description Abstract Background Omalizumab is approved for treating severe allergic asthma from age 6, but the definition of severe asthma including a systematic assessment to rule out difficult-to-treat asthma has changed since the drug was approved in 2003. Methods We conducted a systematic review and meta-analysis of two critical (exacerbation rate, oral corticosteroid (OCS) treatment) and eight important clinical outcomes in children, adolescents and adults, and specifically searched papers for systematic assessment of severe asthma. Results Adults: seven studies (n = 2159) ascertaining exacerbation rate showing a 37% (95% CI 21–50) reduction in favor of omalizumab, larger than the pre-specified minimal clinically important difference (MCID) of 25%. Only one open-label study (n = 82) was identified assessing the percentage of patients experiencing reduction of OCS-maintenance treatment showing a significantly greater decrease in the omalizumab group (− 45% vs. + 18.3%, p = 0.002). Children and adolescents: four studies (n = 1551) reported data on exacerbations (no meta-analysis conducted), showed overall improvements in exacerbation rate and some passed MCID. No OCS studies were identified. No included studies provided systematic assessment of severe asthma according to current guidelines. Conclusions Omalizumab provides clinically relevant improvements in exacerbation rate among children, adolescents, and adults and in OCS-reduction among adults. New studies incorporating a guideline-approached definition of severe asthma are warranted.
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spelling doaj.art-dad67435d1f64bf09391deb0f44ce9952022-12-22T03:40:34ZengBMCAllergy, Asthma & Clinical Immunology1710-14922020-06-0116111210.1186/s13223-020-00442-0Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthmaDaniel P. Henriksen0Uffe Bodtger1Kirsten Sidenius2Niels Maltbaek3Lars Pedersen4Hanne Madsen5Ehm A. Andersson6Ole Norgaard7Louise K. Madsen8Bo L. Chawes9Department of Clinical Biochemistry and Pharmacology, Odense University HospitalDepartment of Respiratory Medicine, Næstved HospitalAllergi og Lungeklinikken HelsingørDepartment of Medicine, Zealand University HospitalDepartment of Respiratory Medicine, Bispebjerg HospitalDepartment of Respiratory Medicine, Odense University HospitalThe Danish Medicines Council SecretariatThe Danish Medicines Council SecretariatThe Danish Medicines Council SecretariatCOPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte University Hospital, University of CopenhagenAbstract Background Omalizumab is approved for treating severe allergic asthma from age 6, but the definition of severe asthma including a systematic assessment to rule out difficult-to-treat asthma has changed since the drug was approved in 2003. Methods We conducted a systematic review and meta-analysis of two critical (exacerbation rate, oral corticosteroid (OCS) treatment) and eight important clinical outcomes in children, adolescents and adults, and specifically searched papers for systematic assessment of severe asthma. Results Adults: seven studies (n = 2159) ascertaining exacerbation rate showing a 37% (95% CI 21–50) reduction in favor of omalizumab, larger than the pre-specified minimal clinically important difference (MCID) of 25%. Only one open-label study (n = 82) was identified assessing the percentage of patients experiencing reduction of OCS-maintenance treatment showing a significantly greater decrease in the omalizumab group (− 45% vs. + 18.3%, p = 0.002). Children and adolescents: four studies (n = 1551) reported data on exacerbations (no meta-analysis conducted), showed overall improvements in exacerbation rate and some passed MCID. No OCS studies were identified. No included studies provided systematic assessment of severe asthma according to current guidelines. Conclusions Omalizumab provides clinically relevant improvements in exacerbation rate among children, adolescents, and adults and in OCS-reduction among adults. New studies incorporating a guideline-approached definition of severe asthma are warranted.http://link.springer.com/article/10.1186/s13223-020-00442-0Severe asthmaAnti-IgEOmalizumabSystematic review
spellingShingle Daniel P. Henriksen
Uffe Bodtger
Kirsten Sidenius
Niels Maltbaek
Lars Pedersen
Hanne Madsen
Ehm A. Andersson
Ole Norgaard
Louise K. Madsen
Bo L. Chawes
Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma
Allergy, Asthma & Clinical Immunology
Severe asthma
Anti-IgE
Omalizumab
Systematic review
title Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma
title_full Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma
title_fullStr Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma
title_full_unstemmed Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma
title_short Efficacy of omalizumab in children, adolescents, and adults with severe allergic asthma: a systematic review, meta-analysis, and call for new trials using current guidelines for assessment of severe asthma
title_sort efficacy of omalizumab in children adolescents and adults with severe allergic asthma a systematic review meta analysis and call for new trials using current guidelines for assessment of severe asthma
topic Severe asthma
Anti-IgE
Omalizumab
Systematic review
url http://link.springer.com/article/10.1186/s13223-020-00442-0
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