Asthma
Conditions
Brief summary
An open-label, single-arm, non-interventional, prospective, multicenter study involving primary data collection within real-world settings for patients who receive benralizumab for treatment of severe uncontrolled eosinophilic asthma
Detailed description
Benralizumab (Fasenra®) is a respiratory biologic agent targeting interleukin-5 (IL-5), an important member of the inflammatory cascade responsible for the pathogenesis of severe asthma. In 2019, Taiwan Food and Drug Administration (TFDA) approved benralizumab for the treatment of severe eosinophilic asthma (SEA). Since March 2020, benralizumab has been reimbursed by Taiwan National Health Insurance (NHI). This prospective study (BEAT) aims to understand the use, effectiveness, and patient reported outcomes (PRO) of reimbursed benralizumab treatment in a real-world setting in Taiwan.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Subjects eligible for enrolment in the study and treated with benralizumab according to Taiwan label and reimbursement criteria must meet ALL the following criteria: 1. Male or female patients ≥ 18 years of age (or ≥ 20 years of age for patients enrolled before January 1st, 2023, according to age of majority as defined by Taiwan regulations), with physician's confirmed diagnosis of severe uncontrolled asthma 2. Asthma requiring medium- or high-dose inhaled corticosteroid plus long-acting β-adrenoceptor agonist as maintenance treatment 3. Patients who have been prescribed but not yet initiated\* treatment with reimbursed benralizumab (Fasenra®) according to the SmPC, prior to signed informed consent, and for whom the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study. \*Note: Treatment may be initiated (administration of first injection) at or after enrolment. Benralizumab Taiwan reimbursement criteria: * ≥ 2 acute exacerbations in the last 12 months, including at least 1 associated with emergency department (ED) visit or hospitalization; AND * At least 6 months of maintenance OCS use at ≥ 5 mg/day of prednisolone or equivalent dose; AND * Peripheral blood eosinophil ≥ 300 cells/μL in the last 12 months within the year before the initiation of benralizumab. 4. Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation 5. Patients must be able and willing to read, comprehend written instructions, and complete the paper questionnaires required by the protocol (ACQ-5, PGI-C, and PGI-S). In case a patient does not own a smartphone or is not willing to perform the home spirometer, enrolment into the study is up to the physicians' discretion. We anticipate that 90% of patients will participate the home spirometer assessment.
Exclusion criteria
Subject must not meet ANY
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting | after 8 weeks of benralizumab treatment | Primary outcome measure: Changes from baseline in Asthma Control Questionnaire, five-question version (ACQ-5) scored from 0 (totally controlled) to 6 (severely uncontrolled) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess change in overall asthma status and disease severity after initiation of benralizumab | at Week 1, 2, 3, 4, 8, 24, and 56 in asthma | Patient Global Impression of Change (PGI-C) response and PGI-C responder endpoint (a little better, moderately better, much better) The PGI-C is a single item designed to capture the participant's perception in change in overall disease status since the first dose of benralizumab using a 7-point scale (1- much better to 7- much worse) |
| To determine the change on lung function after treatment with benralizumab | after 24 and 56 weeks of treatment with benralizumab | Pre-bronchodilator changes in FEV1 and FVC assessed by standard hospital spirometry (if available) |
| To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting | from baseline at Week 24 and 56 | Annualized acute exacerbation rate and changes |
| To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting | at Week 4, 8, 24, and 56 | Mean and median OCS daily dose reductions |
| To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting | known at the time of baseline data collection | Baseline asthma disease history and commodities |
Countries
Taiwan
Contacts
STUDY_DIRECTORClara Tsai
AstraZeneca
Outcome results
None listed