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.

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.

The study will recruit 57 adult patients with confirmed SEA who meet all inclusion criteria and none of the exclusion criteria. Approximately 8 hospitals will participate in the study which have experience with biologic treatment, can initiate treatment with benralizumab, and have a good oversight on the severe asthma population.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.