Severe asthma biologic access criteria should consider long-term oral corticosteroid (LTOCS) users with low blood eosinophil counts (BEC): Implications of STAR study
- puiyeelai
- Jun 12
- 3 min read
The real-world study, “Biomarker profile and disease burden associated with intermittent and long-term oral corticosteroid use in patients with severe asthma prior to biologic initiation in real-life (STAR)”, was recently published in World Allergy Organization Journal. It showed that disease burden remained high among LTOCS users, irrespective of BEC (Figure 1). LTOCS users with low BEC (<150 cells/µL) were as likely as those with high BEC (≥150 cells/µL) to have uncontrolled asthma, exacerbations and evidence of irreversible airflow obstruction. This demonstrates the significant unmet need of LTOCS users with low BEC, who represent 29% of the LTOCS group and yet may not qualify for most biologic therapies in many countries. Biologic access criteria should consider LTOCS users with low BEC.
The STAR study included data (2003 – 2023) from 4,305 patients across 23 countries in the International Severe Asthma Registry (ISAR). Of these patients, 41% were LTOCS (>90 days in the last 12 months) users, 54% were intermittent OCS (iOCS: ≤90 days in the last 12 months, usually short courses for exacerbations) users, and 5% were non-OCS users.
OCS use affects biomarker distributions pre-biologic initiation. As shown in Figure 2, median BEC was significantly lower in the LTOCS vs iOCS group (310 vs 400 cells/µL; p <0.001). Similarly, median IgE was significantly lower in the LTOCS vs iOCS group (154 vs 206 IU; p <0.001). FeNO appears to be less susceptible to OCS-induced suppression; median FeNO was significantly higher in the LTOCS vs iOCS group (40 vs 34 ppb; p <0.001). The effect of OCS on biomarkers could potentially lead to phenotype misclassification. OCS use should be considered when characterizing severe asthma, and earlier phenotyping prior to initiation of LTOCS is recommended.
The STAR study findings are valuable in describing the biomarker distributions and disease characteristics according to OCS use in a large, international cohort of patients with severe asthma pre-biologic initiation. They call for earlier phenotyping in the asthma management pathway and for biologic access criteria to consider LTOCS users with low BEC (<150 cells/µL).
To learn more about the STAR study, please read the full publication in the World Allergy Organization Journal, as well as the accompanying slide deck. Citation: Schleich F et al. World Allergy Organ J 2025;18:101066 [Open access license]. The STAR study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global (OPCG), Sanofi and Regeneron Pharmaceuticals, Inc. ISAR is operated by OPCG and co-funded by OPCG and AstraZeneca.
About OPRI
The Observational and Pragmatic Research Institute (OPRI) is an internationally recognized independent research organization dedicated to providing real-world evidence that supports best practices in chronic disease management in primary care. Learn more at https://www.opri.org.uk/. For media inquiries and additional information, please contact https://www.opri.org.uk/contact.
About ISAR
The International Severe Asthma Registry (ISAR) is the first global adult severe asthma registry, providing a rich, standardized dataset to advance research, clinical practice, and policy in severe asthma care. Since its establishment in 2017, ISAR has recruited >34,000 patients from 30 countries, and undertaken 26 research projects with 31 publications and 63 abstracts. ISAR fosters international collaboration to improve outcomes for patients worldwide. Learn more at https://www.isar.opcglobal.org.
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