Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan (BEAT)

Completed

• Conditions: Asthma

• Registration Number: NCT05734339
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2022-12-15
• Study Start: 2023-01-19
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Primary Completion: 2025-02-03
• Study Completion: 2025-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 exclusion criteria:

1. Documented active lung diseases other than asthma and not within reimbursed label

2. Currently enrolled in an interventional clinical study in parallel, except:

   • Patients being in parallel documented in a national asthma registry
   • Patients having completed any other clinical trials including those with biologic treatment.

3. An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires, participate in this study, or impact the interpretations of results.

4. Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥ 30 days from last dose of previous biologics.

5. Patients already started benralizumab treatment are not allowed. If the patients had received benralizumab treatment before, there should be an interval of ≥ 6 months from the last dose of prior benralizumab course to the newly initiated benralizumab treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting	at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment	Percentage of patients with well-controlled asthma (ACQ-5 ≤ 0.75), partly controlled asthma (ACQ-5 between \> 0.75 and \< 1.5) and not well-controlled asthma (ACQ-5 ≥ 1.5); scored from 0 (totally controlled) to 6 (severely uncontrolled)

Secondary Outcome Measures

Name	Time	Method
To assess change in overall asthma status and disease severity after initiation of benralizumab	Changes from baseline after 1, 2, 3, 4, 8, 24, and 56 weeks	Patient Global Impression of Severity (PGI-S) in asthma; The PGI-S is a single question designed to capture patient's perception of overall symptom severity on a scale of no symptom to very severe
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 describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting	in the past 12 months	Most recent pre-bronchodilator FEV1 and FVC assessed by standard hospital spirometry
To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting	at Week 24 and 56	Severity of exacerbation (use or temporary increase of systemic corticosteroids, emergency department visit, or hospitalization)
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	Changes from baseline in cumulated OCS dose

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taoyuan City, Taiwan