Severe Asthma
Conditions
Brief summary
Benralizumab is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β2-agonists. It has been reimbursed in Portugal as an add-on therapy since May 2019. In order of this, there is crucial need in Portugal to provide key real-word evidence on benralizumab therapy.
Detailed description
This is a real-world retrospective, multicentric, observational study, utilizing secondary data collection from medical records of adults patients (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who, at the discretion of the physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults patients with severe asthma treated with benralizumab, who had their first benralizumab dose between July 2019 and October 2020 * Patients who have at least 1 benralizumab injection and with at least 3 months follow-up data from the first injection. * Give voluntary signed informed consent
Exclusion criteria
* Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with benralizumab | Baseline/Index date | Demographic: Gender, age, BMI, smoking history Clinical: age of asthma diagnosis, ACT score, CARAT score, blood eosinophil count, FeNO, Lung function, FVC, Reversibility of FEV1, Total IgE in peripheral blood, Skin PRICK test |
| Background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation and treatment duration with benralizumab | Baseline, 3, 6, 12 and 24 months | Medication history: asthma treatment type, doses and treatment duration Proportion of patients with biologic discontinued and reason for discontinuation Benralizumab treatment patterns: benralizumab treatment duration, frequency of benralizumab treatment discontinuation, time to treatment discontinuation and frequency and type of concurrent respiratory medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes after initiation of benralizumab theraoy in severe eosinophilic asthma patients | Baseline, 3, 6, 12 and 24 months | Frequency of asthma exacerbations, annual rate of severe exacerbation, mean change in lung function (FEV1), FVC, reversibility of FEV1, blood eosinophil count, FeNO, Total IgE in peripheral blood, CARAT and ACT scores, proportion of patients achieving an improvement in CARAT ACT, percentage of patients with OCS ≤5mg/day, percentage change in daily OCS dose, percentage of patients experiencing reduction daily OCS use from index date by \>0%, ≥25%, ≥50%, ≥75%, ≥90% and 100% |
| Asthma-related Healthcare resource utilization (HCRU) among severe eosinophilic asthma patients before and after initiation of benralizumab therapy | Baseline, 3, 6, 12 and 24 months | Number of emergency room visits, Number of schedule medical visits for asthma, Number of unscheduled medical visits for asthma, Number of hospitalizations |
Countries
Portugal
Outcome results
None listed