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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with benralizumab | 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 | Baseline/Index date |
| Background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation and treatment duration with benralizumab | 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 | Baseline, 3, 6, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes after initiation of benralizumab theraoy in severe eosinophilic asthma patients | 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% |
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Inclusion Criteria:
Adults patients with severe asthma treated with benralizumab, who had their first benralizumab dose between July 2019 and October 2020
Exclusion Criteria:
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Severe eosinophilic asthma patients aged 18 and above, treated with benralizumab and who have had their first benralizumab dose between July 2019 and October 2020 and who have at least 1 benralizumab injection and with at least 3 months follow-up data from the first injection.
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Fernandes | Hospital Pedro Hispano | Principal Investigator |
| Claudia Loureiro | CHUC Pneumo | Principal Investigator |
| Carlos Loureiro | CHUC Imuno | Principal Investigator |
| Ulisses Brito | CHUA - Faro | Principal Investigator |
| Inês Belchior | CHUA - Portimão | Principal Investigator |
| Ana Mendes | CHLN- HSM - Imuno | Principal Investigator |
| Gonçalo Portugal | CHLN - HSM - Pneumo | Principal Investigator |
| Rita Boaventura | Hospital S. João- Pneumo | Principal Investigator |
| José Plácido | Hospital S. João - Imuno | Principal Investigator |
| Cecília Pardal | Hospital Prof. Dr. Fernando Fonseca |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Prof. Dr. Fernando Fonseca | Amadora | 2720-276 | Portugal | |||
| HSMM |
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| Label | URL |
|---|---|
| D3250R00088\_CSR Synopsis\_Redacted | View source |
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No IPD is planned to be shared.
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| Baseline, 3, 6, 12 and 24 months |
| Asthma-related Healthcare resource utilization (HCRU) among severe eosinophilic asthma patients before and after initiation of benralizumab therapy | Number of emergency room visits, Number of schedule medical visits for asthma, Number of unscheduled medical visits for asthma, Number of hospitalizations | Baseline, 3, 6, 12 and 24 months |
| Principal Investigator |
| Gustavo Reis | Hospital Distrital de Santarém | Principal Investigator |
| Ricardo Lima | CHVNGE | Principal Investigator |
| Liliana Ribeiro | Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro | Principal Investigator |
| Nuno Pires | HSMM- Barcelos | Principal Investigator |
| Nuno Sousa | Hospital Leiria | Principal Investigator |
| Filipa Carriço | Hospital São João - CRI | Principal Investigator |
| Barcelos |
| 4750-275 |
| Portugal |
| CHUC - Imunoalergologia | Coimbra | 3000 -076 | Portugal |
| CHUC - Pneumologia | Coimbra | 3000 -076 | Portugal |
| CHUA | Faro | 8000-368 | Portugal |
| Hospital Leiria | Leiria | 2410-197 | Portugal |
| Chln - Hsm | Lisbon | 1649-035 | Portugal |
| Chuln - Hsm | Lisbon | 1649-035 | Portugal |
| Hospital Pedro Hispano | Matosinhos Municipality | 4464-513 | Portugal |
| CHUA | Portimão | 8500-338 | Portugal |
| CHUSJ - Imuno | Porto | 4200 - 319 | Portugal |
| CHUSJ - Pneumo | Porto | 4200 - 319 | Portugal |
| Chusj - Cri | Porto | 4200-319 | Portugal |
| Hospital Distrital de Santarém | Santarém | 2005-177 | Portugal |
| CHVNGE | Vila Nova de Gaia | 4430 - 999 | Portugal |
| CHTMAD | Vila Real | 5000-508 | Portugal |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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