Clinical profiles of patients referred for biological therapy and major limitations in the qualification paths in a specialist asthma centre.

Introduction: Despite the proven efficacy of biologics in the treatment of severe asthma, still a limited number of patients are included in the Polish therapeutic programme. Aim: To identify major limitations in the qualification paths and predominant reasons leading to exclusion from available biologic treatments. The clinical profiles of patients referred for biologics were also examined. Material and methods: Data on demographic characteristics, clinical profile, biomarkers, and medical history from one visit of patients that had been referred for qualification for biologics in 2018/2019 to the Barlicki Hospital (Poland) were collected. A comparison between eligible and ineligible patients was made. Results: Within 2 years, only 116 patients had been referred to the biologic therapy of whom 93 (80%) had been suitable for the biologic programme. Criteria for the omalizumab programme included major limitations such as: frequent use of oral corticosteroids in the past, and serum total-IgE 30-1000 IU/ml, and for mepolizumab were blood eosinophil count (EOScount) > 350/μl and spirometric criterion. Ineligible patients had a significantly lower EOScount and better lung function than eligible individuals despite no significant differences in the number of exacerbations or quality of life between groups. A high percentage of ineligible patients had been referred to re-verify the diagnosis of severe asthma. Conclusions: Potential limitations for biologic therapy include restrictive criteria limiting the group of patients to the most severe cases and referring patients with difficult-to-treat asthma without a differential diagnosis. Low awareness and knowledge among physicians who often are not familiar with qualification criteria require extensive education.