Background
Biologic therapies improve outcomes in severe asthma, but eligibility criteria vary globally, influencing the proportion of patients who qualify. We systematically reviewed studies to estimate the global prevalence of biologic eligibility in patients aged ≥12 years with American Thoracic Society / European Respiratory Society (ATS/ERS)-defined severe asthma and the proportion eligible for each biologic.
Methods
Following PRISMA guidelines (PROSPERO CRD42023393897), we searched MEDLINE, EMBASE, Web of Science, and ClinicalTrials.gov for studies published between 2000 and 2025 that reported the proportion of biologic-naïve, severe asthma patients eligible for omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab, or tezepelumab. Two reviewers independently screened studies, extracted data on eligibility proportions and criteria, and assessed quality using the AXIS tool.
Results
Ten observational studies, including 3500 patients with ATS/ERS-defined severe asthma, met the inclusion criteria. Across all studies, 1770 patients (51%) were eligible for at least 1 biologic, though estimates ranged widely from 24% to 91%, largely reflecting differences in national eligibility criteria. Omalizumab eligibility was reported in 8 studies (16%, range 6%–66%), mepolizumab in 9 studies (27%, 19%–78%), benralizumab in 6 studies (25%, 19%–53%), reslizumab in 6 studies (17%, 6%–41%), and dupilumab in 2 studies (41%, 37%–75%). No study assessed tezepelumab. Overall, the lowest eligibility (24%) was reported in the European IDEAL cohort due to stringent exacerbation and biomarker criteria, whereas the highest (91%) was observed in a Canadian single-centre cohort using less restrictive national regulatory criteria.
Conclusion
Globally, approximately 51% of adults with severe asthma are eligible for biologic therapy, excluding tezepelumab. Among available biologics, eligibility is generally higher for anti-IL5/IL5Rα therapies than for anti-IgE, and appears highest for anti-IL4Rα, although data for the latter remain limited.
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