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Published on: November 4, 2010
First analysis of the Severe Paediatric Asthma Collaborative in Europe registry
Norrice M Liu1, Karin C L Carlsen2,3, Steve Cunningham4
1Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.
Insights
The Severe Paediatric Asthma Collaborative in Europe (SPACE) registry found that most children with severe asthma have suboptimal control, even on biologics. This highlights the need for new trial designs for pediatric asthma biologics.
Area of Science:
- Pediatric Pulmonology
- Clinical Trials
Background:
- Biologics are emerging for pediatric asthma, but trial recruitment is uncertain due to patient numbers.
- Severe pediatric asthma requires effective treatment strategies and robust clinical trial data.
Purpose of the Study:
- To assess the feasibility of recruiting children with severe asthma for clinical trials.
- To analyze the control status and treatment of severe pediatric asthma in Europe.
Main Methods:
- The Severe Paediatric Asthma Collaborative in Europe (SPACE) registry collected data from 80 children with severe asthma across 10 European centers.
- Data were gathered between January 2019 and January 2020, focusing on high-dose inhaled corticosteroid and long-acting β2-agonist use.
- Suboptimal control was defined by specific criteria, including exacerbations and asthma control scores.
Main Results:
- 77% (62/80) of children exhibited suboptimal asthma control.
- Among those with suboptimal control, 29 were not on biologics, while 33 were on omalizumab, mepolizumab, or dupilumab.
- Many children on biologics still had poor control, indicating a need for treatment optimization or switching strategies.
Conclusions:
- The SPACE registry provides valuable data for planning pediatric asthma biologic trials.
- Current biologic therapies do not ensure optimal control for all children with severe asthma.
- There is a clear need for innovative trial designs to evaluate biologic switching in pediatric severe asthma.
Abstract:
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.
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