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Impact of season and geography on CompEx Asthma: a composite end-point for exacerbations

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Jauhiainen, A, Scheepers, LEJM ORCID: 0000-0001-6792-8506, Fuhlbrigge, AL, Harrison, T, Zangrilli, J, Garcia Gil, E, Gustafson, P, Fageras, M and Da Silva, CA 2020 , 'Impact of season and geography on CompEx Asthma: a composite end-point for exacerbations' , ERJ open research, vol. 6, no. 4 , pp. 1-9 , doi: 10.1183/23120541.00246-2020.

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Abstract

Background: CompEx Asthma, a novel composite end-point combining severe exacerbations (SevEx) withasthma-worsening events, was recently developed. Further characterisation of CompEx Asthma is neededto illustrate the applicability of this end-point. The objective was to evaluate CompEx Asthma as a rateend-point to determine how seasonal and geographical factors impact this novel outcome.Methods: Seven 24–56-week randomised controlled trials of budesonide/formoterol (BUD/FORM) andbenralizumab were analysed. Annualised event rates (AERs) and treatment effects (hazard ratio (HR)) wereanalysed with Poisson and Andersen–Gill models, respectively. Seasonality was analysed by month andfive geographical regions were evaluated.Results: The studies included 10815 patients (63% female, mean age 42–49 years). CompEx Asthma AERmirrored seasonal variations in SevEx AER. CompEx Asthma AERs were higher versus SevEx in BUD/FORMand benralizumab trials (range 2.7–4.5-fold and 1.3–2.0-fold increase, respectively) and were less variableversus SevEx between regions (ratios of greatest:smallest AERs: 1.36 for CompEx versus 2.28 for SevEx (BUD/FORM); 1.81 for CompEx versus 2.22 for SevEx (benralizumab)). Treatment effects for CompEx Asthma andSevEx were generally similar across regions and months. However, in Eastern Europe, where SevEx rates werelowest, treatment effect was greater with CompEx Asthma versus SevEx, reaching statistical significance in thebenralizumab studies (HR (95% CI): 0.67 (0.53–0.85) versus 0.87 (0.65–1.15)).Conclusion: This study confirmed the reliability of CompEx Asthma as a rate end-point and alloweddetection of variations in seasonal SevEx rates, reduction of variation in rates across regions and potentialgreater sensitivity to treatment effects.

Item Type: Article
Authors/Creators:Jauhiainen, A and Scheepers, LEJM and Fuhlbrigge, AL and Harrison, T and Zangrilli, J and Garcia Gil, E and Gustafson, P and Fageras, M and Da Silva, CA
Keywords: drug development, asthma, exacerbations, statistics, epidemiology
Journal or Publication Title: ERJ open research
Publisher: European Respiratory Society
ISSN: 2312-0541
DOI / ID Number: 10.1183/23120541.00246-2020
Copyright Information:

Copyright 2020 ERS. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.

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