PMID- 32565844 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220415 IS - 1710-1484 (Print) IS - 1710-1492 (Electronic) IS - 1710-1484 (Linking) VI - 16 DP - 2020 TI - 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. PG - 49 LID - 10.1186/s13223-020-00442-0 [doi] LID - 49 AB - 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. CI - (c) The Author(s) 2020. FAU - Henriksen, Daniel P AU - Henriksen DP AUID- ORCID: 0000-0003-1303-6195 AD - Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark. GRID: grid.7143.1. ISNI: 0000 0004 0512 5013 AD - Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense, Denmark. GRID: grid.10825.3e. ISNI: 0000 0001 0728 0170 FAU - Bodtger, Uffe AU - Bodtger U AD - Department of Respiratory Medicine, Naestved Hospital, Naestved, Denmark. GRID: grid.416369.f. ISNI: 0000 0004 0631 4668 AD - Department of Medicine, Zealand University Hospital, Roskilde, Denmark. GRID: grid.476266.7 FAU - Sidenius, Kirsten AU - Sidenius K AD - Allergi og Lungeklinikken Helsingor, Helsingor, Denmark. FAU - Maltbaek, Niels AU - Maltbaek N AD - Department of Medicine, Zealand University Hospital, Roskilde, Denmark. GRID: grid.476266.7 FAU - Pedersen, Lars AU - Pedersen L AD - Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark. GRID: grid.411702.1. ISNI: 0000 0000 9350 8874 FAU - Madsen, Hanne AU - Madsen H AD - Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark. GRID: grid.7143.1. ISNI: 0000 0004 0512 5013 FAU - Andersson, Ehm A AU - Andersson EA AD - The Danish Medicines Council Secretariat, Copenhagen, Denmark. FAU - Norgaard, Ole AU - Norgaard O AD - The Danish Medicines Council Secretariat, Copenhagen, Denmark. FAU - Madsen, Louise K AU - Madsen LK AD - The Danish Medicines Council Secretariat, Copenhagen, Denmark. FAU - Chawes, Bo L AU - Chawes BL AD - COPSAC, Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte University Hospital, University of Copenhagen, Ledreborg Alle 34, Gentofte, 2820 Copenhagen, Denmark. GRID: grid.5254.6. ISNI: 0000 0001 0674 042X LA - eng PT - Journal Article PT - Review DEP - 20200618 PL - England TA - Allergy Asthma Clin Immunol JT - Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology JID - 101244313 PMC - PMC7302157 OTO - NOTNLM OT - Anti-IgE OT - Omalizumab OT - Severe asthma OT - Systematic review COIS- Competing interestsThe authors declare that they have no competing interests. EDAT- 2020/06/23 06:00 MHDA- 2020/06/23 06:01 PMCR- 2020/06/18 CRDT- 2020/06/23 06:00 PHST- 2019/11/16 00:00 [received] PHST- 2020/05/23 00:00 [accepted] PHST- 2020/06/23 06:00 [entrez] PHST- 2020/06/23 06:00 [pubmed] PHST- 2020/06/23 06:01 [medline] PHST- 2020/06/18 00:00 [pmc-release] AID - 442 [pii] AID - 10.1186/s13223-020-00442-0 [doi] PST - epublish SO - Allergy Asthma Clin Immunol. 2020 Jun 18;16:49. doi: 10.1186/s13223-020-00442-0. eCollection 2020.