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Review
. 2025 Aug 13;15(8):370.
doi: 10.3390/jpm15080370.

Established and Emerging Asthma Biomarkers with a Focus on Biologic Trials: A Narrative Review

Philip F Lavere  1 , Kaitlin M Phillips  1 , Nicola A Hanania  1 , Muhammad Adrish  1
Affiliations
Review

Established and Emerging Asthma Biomarkers with a Focus on Biologic Trials: A Narrative Review

Philip F Lavere et al. J Pers Med. .

Abstract

Chronic airway inflammation with variable airflow obstruction is clinical asthma, and it arises from distinct molecular and pathological mechanisms called endotypes. Biomarkers allow for precise endotype characterization and have been used in clinical trials to design, monitor, and evaluate outcomes for asthma biologic therapies. This review will highlight the central and evolving role of biomarkers for past, present, and future asthma, with a focus on regulatory-approved biologic therapies and emerging biomarkers. Established biomarkers, including serum immunoglobulin E (IgE), blood eosinophils, the fraction of exhaled nitric oxide (FeNO), and serum periostin, helped elucidate the complex pathophysiology of the eosinophilic type 2 (T2) asthma endotype. Emerging biomarkers, or older biomarkers with emerging utility, include sputum inflammatory cells (eosinophils, neutrophils, interleukins), thymus and activation-regulated chemokine (TARC), plasma eotaxin-3, eosinophil peroxidase (EPX), Clara/club cell secretory protein (CC16), and quantitative computerized tomography (QCT) imaging biomarkers (evaluating mucus plugging, air trapping, airway wall thickness, small airway remolding) and are increasingly used in clinical trials as secondary endpoints in evaluating efficacy, as well as in the clinical setting at specialized centers. The rapid advances in asthma research, due in part to biomarkers and biologic therapies, may soon standardize an end goal: symptom-free asthma remission without exacerbations.

Keywords: FeNO; IgE; asthma endotypes; asthma remission; benralizumab; biomarkers; blood eosinophils; dupilumab; mepolizumab; omalizumab; tezepelumab.

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Conflict of interest statement

N.A.H. received honoraria for serving as an advisor or consultant for GSK, AstraZeneca, Sanofi, Regeneron, Amgen, Genentech, Novartis, and Teva. His institution received research grant support on his behalf from GSK, Genentech, Sanofi, Teva, Novartis, and AstraZeneca. M.A. serves as a consultant for AstraZeneca. No financial compensation has been received for this role. Other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Key highlights of T2-mediated inflammation in eosinophilic asthma [5,6,7]. (created with biorender.com).
See this image and copyright information in PMC

References

    1. FDA-NIH Biomarker Working Group . BEST (Biomarkers, EndpointS, and other Tools) Resource. Food and Drug Administration; Silver Spring, MD, USA: 2016. - PubMed
    1. Chung K.F., Wenzel S.E., Brozek J.L., Bush A., Castro M., Sterk P.J., Adcock I.M., Bateman E.D., Bel E.H., Bleecker E.R., et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur. Respir. J. 2014;43:343–373. doi: 10.1183/09031936.00202013. - DOI - PubMed
    1. Holguin F., Cardet J.C., Chung K.F., Diver S., Ferreira D.S., Fitzpatrick A., Gaga M., Kellermeyer L., Khurana S., Knight S., et al. Management of severe asthma: A European Respiratory Society/American Thoracic Society guideline. Eur. Respir. J. 2020;55:1900588. doi: 10.1183/13993003.00588-2019. - DOI - PubMed
    1. Global Initiative for Asthma 2025 GINA Main Report. Global Strategy for Asthma Management and Prevention. [(accessed on 3 June 2025)]. Available online: https://ginasthma.org/reports/
    1. Kuruvilla M.E., Lee F.E.H., Lee G.B. Understanding Asthma Phenotypes, Endotypes, and Mechanisms of Disease. Clin. Rev. Allergy Immunol. 2019;56:219–233. doi: 10.1007/s12016-018-8712-1. - DOI - PMC - PubMed

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