Real-world patient characteristics and eligibility for biologics in severe asthma (RECOGNISE)

Background: Despite advances in the field of biologic therapies, clinical management of severe asthma still represents an unmet need. Aims and objectives: The aim of the study was to generate real-world data on the characteristics of severe asthma patients and their eligibility for biologics. Methods: In this cross-sectional study, patient characteristics and patient-reported outcomes were collected from severe asthma patients at a single study visit in primary and secondary care settings in Europe. Investigators were asked to share their judgement on the patients' eligibility for biologics and their suitability for referral to specialized care for further clinical assessment. Results: Between 04/2018 and 07/2020, 1025 severe asthma patients were assessed in 12 European countries. The investigator's specialty differed by region (99% vs 22% specialists in Eastern vs Western Europe) due to different healthcare systems. Most patients were female (69%) and diagnosed at adult age (median 42 years). Median eosinophil counts were 300 cells/µl, IgE levels 158 UI/ml and FeNO 29.5 ppb. Over the previous year, 25% received long-term oral corticosteroid therapy (≥50% of year), 69% received short-course systemic corticosteroids (>3 days) and 78% had exacerbations. Asthma control was poor (mean ACQ-6 score 2.6, 95% CI 2.5–2.6). Per clinical judgement, 75% were considered eligible for biologics; 62% were eligible per label criteria. Label criteria were in agreement with the investigators' judgement in Western Europe. Moreover, 66% were candidates for referral to specialists in Western Europe. Conclusions: In this study, the majority of severe asthma patients were eligible for biologics, highlighting the current shortcomings in the management of severe asthma.