Baseline disease burden in severe asthma patients treated with biologics, and eligible but not treated: Spanish patients in the ISAR Registry

Title: Baseline disease burden in severe asthma patients treated with biologics, and eligible but not treated: Spanish patients in the ISAR Registry.
Background: Despite availability of multiple biologics approved for severe asthma, not all patients eligible in terms of disease burden and biomarkers for these treatments currently receive them. The aim of this analysis is to describe disease burden of patients with severe uncontrolled asthma (SUA) in Spain who were treated with biologics, and those eligible but not treated. Methods This was a historical cohort study of patients from Spain enrolled in the International Severe Asthma Registry (ISAR) using prospective data collected between December 1, 2017 and May 11, 2022. Patients aged ≥18 years, receiving GINA step 5 treatment or step 4 treatment but still uncontrolled were included. Demographics, clinical variables, medication use were collected at baseline, defined as the 12 months period prior to the first ISAR visit when patients treated with biological therapies (group A) and patients who were eligible but not treated with them (group B) met their respective group definitions.
Results: Of 568 patients with SUA eligible for biologic therapy, 514 were treated with biologics (group A) and 54 not (group B). At baseline, group B patients were mostly uncontrolled (52% vs 46% in group A) and showed a higher proportion of patients with ≥2 exacerbations (27,8% vs 23,5%). Similarly, 42.6% of biologic-eligible but untreated patients received long-term OCS against 37% of group A patients. In group A, 9.8% of patients and 7.4% patients in group B experienced at least one hospital admission. In relation to T2 inflammation biomarkers, the median in both groups exceeded the elevated thresholds (IgE ≥ 75 IU/mL, BEC ≥ 300 cells/µL and FeNO ≥ 25 ppb), which indicate high biomarker levels in both groups (Table 1).
Conclusions: Similar to patients treated with biologics, SUA patients eligible but not treated with biologics experienced high disease burden and should be considered for biologics therapy.