First analysis of the Severe Paediatric Asthma Collaborative in Europe registry.


Journal

ERJ open research
ISSN: 2312-0541
Titre abrégé: ERJ Open Res
Pays: England
ID NLM: 101671641

Informations de publication

Date de publication:
Oct 2020
Historique:
received: 11 08 2020
accepted: 14 08 2020
entrez: 2 12 2020
pubmed: 3 12 2020
medline: 3 12 2020
Statut: epublish

Résumé

New biologics are being continually developed for paediatric asthma, but it is unclear whether there are sufficient numbers of children in Europe with severe asthma and poor control to recruit to trials needed for registration. To address these questions, the European Respiratory Society funded the Severe Paediatric Asthma Collaborative in Europe (SPACE), a severe asthma registry. We report the first analysis of the SPACE registry, which includes data from 10 paediatric respiratory centres across Europe. Data from 80 children with a clinical diagnosis of severe asthma who were receiving both high-dose inhaled corticosteroid and long-acting β2-agonist were entered into the registry between January 2019 and January 2020. Suboptimal control was defined by either asthma control test, or Global Initiative for Asthma criteria, or ≥2 severe exacerbations in the previous 12 months, or a combination. Overall, 62 out of 80 (77%) children had suboptimal asthma control, of whom 29 were not prescribed a biologic. However, in 24 there was an option for starting a licensed biologic. 33 children with suboptimal control were prescribed a biologic (omalizumab (n=24), or mepolizumab (n=7), or dupilumab (n=2)), and for 29 there was an option to switch to a different biologic. We conclude that the SPACE registry provides data that will support the planning of studies of asthma biologics. Not all children on biologics achieve good asthma control, and there is need for new trial designs addressing biologic switching.

Identifiants

pubmed: 33263064
doi: 10.1183/23120541.00566-2020
pii: 00566-2020
pmc: PMC7682719
pii:
doi:

Types de publication

Journal Article

Langues

eng

Informations de copyright

Copyright ©ERS 2020.

Déclaration de conflit d'intérêts

Conflict of interest: N.M. Liu has nothing to disclose. Conflict of interest: K.C.L. Carlsen has nothing to disclose. Conflict of interest: S. Cunningham has nothing to disclose. Conflict of interest: G. Fenu reports advisory board fees from GSK, clinical trial sponsorship from Sanofi, expenses for congresses and meetings from Novartis, personal fees for teaching a course from Chiesi, and expenses for congresses and meetings from Lusofarmaco, outside the submitted work. Conflict of interest: L.J. Fleming reports grants from Asthma UK, and fees for expert consultation and speakers fees from AstraZeneca, GSK, Novartis, Teva, Bohringer Ingelheim, Respiri and Sanofi paid direct to her institution and outside of the submitted work Conflict of interest: M. Gappa reports that she has received honoraria for lectures and/or consultancy from Boehringer Ingelheim, GSK, Novartis and Sanofi. She believes that this has not influenced any of the submitted work. Conflict of interest: B. Karadag reports for the multicentre, phase III dupilumab study EFC14153 from Sanofi, outside the submitted work. Conflict of interest: F. Midulla has nothing to disclose. Conflict of interest: L. Petrarca has nothing to disclose. Conflict of interest: M.W.H. Pijnenburg reports a consultancy fee paid to her department by Sanofi Genzyme during the conduct of the study. Conflict of interest: T. Reier-Nilsen has nothing to disclose. Conflict of interest: N.W. Rutjes has nothing to disclose. Conflict of interest: F. Rusconi has nothing to disclose. Conflict of interest: J. Grigg reports personal fees for asthma advisory boards from AstraZeneca and GSK, personal fees for a continuing professional development lecture from Novartis, and personal fees for an asthma advisory board from Vifor Pharma, outside the submitted work.

Références

Lancet Respir Med. 2018 Aug;6(8):581-583
pubmed: 30070256
Eur Respir J. 2018 Oct 18;52(4):
pubmed: 30337488
Ann Am Thorac Soc. 2014 May;11(4):531-6
pubmed: 24606022
Eur Respir J. 2005 Aug;26(2):319-38
pubmed: 16055882
J Allergy Clin Immunol. 2006 Mar;117(3):549-56
pubmed: 16522452
Am J Respir Crit Care Med. 2011 Sep 1;184(5):602-15
pubmed: 21885636
Breathe (Sheff). 2018 Mar;14(1):59-62
pubmed: 29515670
Eur Respir J. 2014 Feb;43(2):343-73
pubmed: 24337046
Pediatr Pulmonol. 2019 Jun;54(6):778-787
pubmed: 30884194
Eur Respir J. 2012 Dec;40(6):1324-43
pubmed: 22743675
Cochrane Database Syst Rev. 2014 Jan 13;(1):CD003559
pubmed: 24414989
J Allergy Clin Immunol. 1995 Nov;96(5 Pt 1):580-7
pubmed: 7499673
Breathe (Sheff). 2018 Jun;14(2):93-98
pubmed: 29875828

Auteurs

Norrice M Liu (NM)

Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.

Karin C L Carlsen (KCL)

Dept of Paediatrics, Faculty of Medicine, University of Oslo, Oslo, Norway.
Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.

Steve Cunningham (S)

Centre for Inflammation Research, University of Edinburgh, Queen's Medical Research Institute, Edinburgh, UK.

Grazia Fenu (G)

Paediatrics Pulmonology Unit, Anna Meyer Children's Hospital, Florence, Italy.

Louise J Fleming (LJ)

National Heart and Lung Institute, Imperial College, London, UK.

Monika Gappa (M)

Children's Hospital, Evangelisches Krankenhaus Duesseldorf, Düsseldorf, Germany.

Bülent Karadag (B)

Division of Pediatric Pulmonology, Marmara University, Istanbul, Turkey.

Fabio Midulla (F)

Dept of Maternal Science, Sapienza University of Rome, Rome, Italy.

Laura Petrarca (L)

Dept of Maternal Science, Sapienza University of Rome, Rome, Italy.

Marielle W H Pijnenburg (MWH)

Dept of Pediatrics, Division of Respiratory Medicine and Allergology, Erasmus MC-Sophia Children's Hospital, Erasmus University Medical Centre, Rotterdam, The Netherlands.

Tonje Reier-Nilsen (T)

Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo, Norway.

Niels W Rutjes (NW)

Dept of Paediatric Respiratory Medicine, Emma Children's Hospital/Amsterdam UMC, Amsterdam, The Netherlands.

Franca Rusconi (F)

Epidemiology Unit, Anna Meyer Children's University Hospital, Florence, Italy.

Jonathan Grigg (J)

Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.

Classifications MeSH