Characteristics of patients with severe asthma in primary and secondary care settings considered eligible for biological therapy – the Bulgarian RECOGNISE study

Abstract

Introduction: Asthma is a major non-communicable disease. It affects both children and adults, but is the most common chronic condition among the former. While inhaled controller drugs stabilize the disease in most asthma patients, there are a certain number of people who suffer from severe asthma, which requires treatment escalation. Oral corticosteroids are usually added, but they are associated with various side effects that may limit their application. The introduction of biologicals targeting inflammatory mediators has opened a new era of asthma treatment highlighting the importance of patient characterization. Aim: The RECOGNISE study sought to provide real-world insight into the characteristics of patients deemed eligible for biological therapy based on the judgment of the clinical investigator in primary and secondary care settings. Materials and methods: The RECOGNISE study was a multicenter, observational, cross-sectional, one-visit study to characterize those severe asthma patients who are considered eligible for biological therapy among asthma patients in primary and secondary care settings in Bulgaria. Female and male asthma patients over 18 years of age were enrolled at four sites across the country. Severe asthma diagnosis had to be in agreement with the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Patients provided patient-reported outcomes on asthma control and health-related quality of life (HRQoL). Investigators completed specifically designed electronic case report forms (eCRFs), which included demographics and medical history. Medical history included lung function, biomarkers, comorbidities, exacerbations, Healthcare Resource Utilization (HRU), and prescribed asthma medication in the last 12 months as well as adherence to medication. Results: Ninety-two severe asthma patients were enrolled in the Bulgarian RECOGNISE study (females prevailing – 65.22%). The median age (range) at diagnosis was 40 (18, 74) years. Most patients were never-smokers (n=72, 78.26%). For eligible patients, the median total EOS blood count was 431.0 cells/µl (n=19) and the blood EOS percentage was 5.95% (n=64). Chronic OCS use (treatment maintenance with OCS for ≥50% of the previous year) was documented for 30.1% of eligible patients. The results from the Bulgarian RECOGNISE cohort show that 90.2% of the severe asthma patients from the primary and secondary care sites are eligible for treatment with the approved biologicals. Conclusions: The current findings emphasize how crucial it is for patients with severe asthma to be monitored by an asthma specialist who can determine when it is time to switch to biologicals.