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
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 Type
OBSERVATIONAL
Enrollment
43
Research Site
Changhua, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
New Taipei City, Taiwan
Research Site
Tainan, Taiwan
Research Site
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Primary outcome measure: Changes from baseline in Asthma Control Questionnaire, five-question version (ACQ-5) scored from 0 (totally controlled) to 6 (severely uncontrolled)
Time frame: after 8 weeks of benralizumab treatment
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Secondary outcome measure: Changes from baseline in ACQ-5 scored from 0 (totally controlled) to 6 (severely uncontrolled)
Time frame: after 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Secondary outcome measure: Percentage of patients with an improvement of ≥ 0.5 points (minimal clinically importance differences \[MCID\]) in ACQ-5 scored from 0 (totally controlled) to 6 (severely uncontrolled)
Time frame: at 1, 2, 3, 4, 8, 24, and 56 weeks compared to baseline
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
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)
Time frame: at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment
To assess change in overall asthma status and disease severity after initiation of benralizumab
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Taipei, Taiwan
Research Site
Taoyuan City, Taiwan
Time frame: at Week 1, 2, 3, 4, 8, 24, and 56 in asthma
To assess change in overall asthma status and disease severity after initiation of benralizumab
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
Time frame: Changes from baseline after 1, 2, 3, 4, 8, 24, and 56 weeks
To determine the change on lung function after treatment with benralizumab
Pre-bronchodilator changes in FEV1 and FVC assessed by standard hospital spirometry (if available)
Time frame: after 24 and 56 weeks of treatment with benralizumab
To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
Annualized acute exacerbation rate and changes
Time frame: from baseline at Week 24 and 56
To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
Proportion of patients with 0, 1, and ≥ 2 acute exacerbations
Time frame: at Week 24 and 56
To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
Severity of exacerbation (use or temporary increase of systemic corticosteroids, emergency department visit, or hospitalization)
Time frame: at Week 24 and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Mean and median OCS daily dose reductions
Time frame: at Week 4, 8, 24, and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Proportion of patients with a ≥ 25%, ≥ 50%, ≥ 75%, and 100% OCS daily dose reduction
Time frame: at Week 4, 8, 24, and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Changes from baseline in cumulated OCS dose
Time frame: at Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Baseline asthma disease history and commodities
Time frame: known at the time of baseline data collection
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Background medication
Time frame: at baseline and at Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Biomarker status (blood eosinophil and serum IgE level, if available)
Time frame: at baseline and Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Adherence to benralizumab scheduled dose during study period and investigator-chosen reasons for discontinuation
Time frame: through study completion, up to 56 weeks
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Most recent pre-bronchodilator FEV1 and FVC assessed by standard hospital spirometry
Time frame: in the past 12 months