Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium

Prior treatment

• Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment. Acceptable wash-out periods for other asthma biologics:
• ≥30 days from last dose of previous biologic

Other illness

• Patients with other documented lung disease other than asthma and not within reimbursed label.

Other

• Patients currently enrolled in an interventional clinical study in parallel (i.e. have not completed) including those with biologic treatment, will be excluded from the study except for patients who are in parallel documented in the Belgian Severe Asthma Registry (BSAR).

• Male or female patients 18 years or older with physician's confirmed diagnosis of severe, uncontrolled asthma
• Asthma requiring high dose inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment
• A decreased lung function (FEV1 \<80%), demonstrated by spirometry in the 12 months before initiation of treatment
• Patients need to fulfil one of the criteria:
  • at least 2 hospitalizations or ER treatments for severe asthma during last 12 months, or
  • at least 2 asthma exacerbations during last 12 months (worsening of asthma with need of systemic corticotherapy for at least 3 days for non cortico-dependent patients, and/or an ER visit and or a hospitalization),
  • or cortico-dependent (at least 6 months treatment with OCS at a daily dose of 4 mg or more of methylprednisolone or 5 mg or more of prednisolone for adults)
• Peripheral blood eosinophil count ≥300cells/μl at initiation of benralizumab treatment and in the year before.
• Obtained reimbursement for treatment with benralizumab
• Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation in the study.
• Patients must be able and willing to read and comprehend written instructions and comprehend and complete the questionnaires required by the protocol.
• Benralizumab naïve and have not previously received benralizumab prior to the start of this study.