Change in measured Patient-Reported Outcomes in severe eosinophilic asthma patients treated with benralizumab under real life conditions in Germany (imPROve asthma study) – Study Design

Rationale: Patients with severe eosinophilic asthma (SEA) often have poor disease control with recurrent exacerbations leading to impaired health-related quality of life. Benralizumab is approved in the EU as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dosage inhaled corticosteroids plus long-acting β-agonists. Data on the therapeutic effects of benralizumab in real-word settings are limited. Here we describe the design of imPROve asthma, a real-world study that aims to capture data that is patient-relevant for both endpoints and time points.

Methods: The imPROve asthma study is a prospective, observational, multicentre, 12-month study in patients treated with benralizumab therapy in pulmonary care settings in Germany. Patients will be initiated on benralizumab treatment according to routine care as provided by their physician and study visits will occur in line with clinic visits, approximately every month (visits 1 – 3), then every 2 months (visits 4 and 5), then at 12 months (follow-up visit) ([Fig. 1]).

Fig. 1 ImPROve asthma study design.

Results: Approximately 250 anti-interleukin-5 (IL5)/anti-IL5Rα treatment naïve adult patients and up to 250 biologic-experienced patients will be enrolled at approximately 40 sites in clinics and by field-based pulmonologists. The study is due to commence by the end of 2019. Validated questionnaires (Asthma Control Test (ACT), Asthma Control Questionnaire-6, St Georgeʼs Respiratory Questionnaire) and exploratory Visual Analogue Scale assessments will be used, as well as an objective measure of physical activity (step counts per day by activity tracker). In addition to results captured at clinic visits, outcomes will be also measured at home during the first 2 weeks (to assess early treatment response). The primary endpoint is change in ACT score after 6 months treatment.

Conclusions: The imPROve asthma study will provide patient-relevant outcome data in patients with SEA and will be the first study to measure real-life physical activity throughout the study. These results should aid physician decisions about disease management in this asthma population.

Sponsor: AstraZeneca