Development of an asthma health-care burden score as a measure of severity and predictor of remission in SARP III and U-BIOPRED: results from two major longitudinal asthma cohorts

Joe G Zein; Nazanin Zounemat-Kerman; Ian M Adcock; Bo Hu; Amy Attaway; Mario Castro; Sven-Erik Dahlén; Loren C Denlinger; Serpil C Erzurum; John V Fahy; Benjamin Gaston; Annette T Hastie; Elliot Israel; Nizar N Jarjour; Bruce D Levy; David T Mauger; Wendy Moore; Michael C Peters; Kaharu Sumino; Elizabeth Townsend; Prescott Woodruff; Victor E Ortega; Sally E Wenzel; Deborah A Meyers; Kian Fan Chung; Eugene R Bleecker; Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) Consortium and the the US National Heart, Lung, and Blood Institute Severe Asthma Research Program (SARP III)

doi:10.1016/S2213-2600(24)00250-9

Development of an asthma health-care burden score as a measure of severity and predictor of remission in SARP III and U-BIOPRED: results from two major longitudinal asthma cohorts

Lancet Respir Med. 2024 Nov 22:S2213-2600(24)00250-9. doi: 10.1016/S2213-2600(24)00250-9. Online ahead of print.

Authors

Joe G Zein¹, Nazanin Zounemat-Kerman², Ian M Adcock², Bo Hu³, Amy Attaway⁴, Mario Castro⁵, Sven-Erik Dahlén⁶, Loren C Denlinger⁷, Serpil C Erzurum⁴, John V Fahy⁸, Benjamin Gaston⁹, Annette T Hastie¹⁰, Elliot Israel¹¹, Nizar N Jarjour⁷, Bruce D Levy¹¹, David T Mauger¹², Wendy Moore¹⁰, Michael C Peters⁸, Kaharu Sumino¹³, Elizabeth Townsend⁷, Prescott Woodruff⁸, Victor E Ortega¹⁴, Sally E Wenzel¹⁵, Deborah A Meyers¹⁴, Kian Fan Chung², Eugene R Bleecker¹⁴; Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) Consortium and the the US National Heart, Lung, and Blood Institute Severe Asthma Research Program (SARP III)

Affiliations

¹ Division of Pulmonary Medicine, Department of Medicine, Mayo Clinic, Scottsdale, AZ, USA. Electronic address: Zein.Joe@mayo.edu.
² Data Science Institute and National Heart & Lung Institute, Imperial College London, London, UK.
³ Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA.
⁴ Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; Respiratory Institute, Cleveland Clinic, Cleveland, OH, USA.
⁵ Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.
⁶ The National Institute of Environmental Medicine, Karolinska Institutet, Solna, Sweden.
⁷ Department of Medicine, University of Wisconsin School of Medicine, Madison, WI, USA.
⁸ Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California at San Francisco, San Francisco, CA, USA.
⁹ Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
¹⁰ Department of Medicine, Wake Forest University, Winston-Salem, NC, USA.
¹¹ Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
¹² Center for Biostatistics and Epidemiology, Pennsylvania State University School of Medicine, Hershey, PA, USA.
¹³ Division of Pulmonary and Critical Care Medicine, Washington University College of Medicine, Saint Louis, MO, USA.
¹⁴ Division of Pulmonary Medicine, Department of Medicine, Mayo Clinic, Scottsdale, AZ, USA.
¹⁵ Department of Environmental and Occupational Health, University of Pittsburgh, Pittsburgh, PA, USA.

PMID: 39586307
DOI: 10.1016/S2213-2600(24)00250-9

Abstract

Background: Current asthma guidelines, including those of the European Respiratory Society (ERS) and American Thoracic Society (ATS), suboptimally predict asthma remission, disease severity, and health-care utilisation. We aimed to establish a novel approach to assess asthma severity based on asthma health-care burden data.

Methods: We analysed prospectively collected data from the Severe Asthma Research Program III (SARP III; USA) and the European Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED; 11 European countries) to calculate a composite burden score based on asthma exacerbations and health-care utilisation, which was modified to include the use of short-acting beta agonists (SABAs) to reflect asthma symptom burden.

Findings: In SARP III, 528 adult participants with asthma were followed up for a mean of 4·4 (SD 1·6) years, and 312 (59%) had severe asthma according to the ERS-ATS definition. Among the 205 participants with asthma who used rescue SABAs daily, 90 used these two or more times a day. In U-BIOPRED, 509 adult participants with asthma were followed up for 1 year, and 421 (83%) had severe asthma. The burden score was less than 1·29 per patient-year in 106 (34%) of 312 SARP III participants and in 80 (19%) of 421 U-BIOPRED participants with severe asthma. By contrast, the burden score was above the median value in 58 (28%) SARP III and 24 (27%) U-BIOPRED participants with non-severe asthma. In both cohorts, the burden score negatively correlated with lung function, asthma control, and quality of life. A burden score of 0·15 or lower predicted asthma remission with a sensitivity greater than 91% and a specificity of 99%.

Interpretation: Our findings highlight considerable discrepancies between the current definition of asthma severity and our burden score. Although the definition of severe asthma proposed by the ERS-ATS and the and Global Initiative for Asthma (GINA) is based on prescribed asthma medications, our personalised health-care burden score includes patient-centred data that reflect disease severity and accurately predicts asthma remission. Subject to prospective validation, the burden score could help to optimise the management of high-risk individuals with asthma.

Funding: SARP III: US National Heart, Lung, and Blood Institute; AstraZeneca; Boehringer Ingelheim; Genentech; GlaxoSmithKline; Sanofi Genzyme/Regeneron; and Teva Pharmaceuticals.

U-biopred: Innovative Medicines Initiative Joint Undertaking (EU's Seventh Framework Programme and European Federation of Pharmaceutical Industries and Associations) and eTRIKS project.