This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.
Adults (≥ 18 years old) diagnosed with severe uncontrolled eosinophilic asthma.
Benralizumab has been prescribed according to the approved label and local reimbursement criteria
Provision of signed Informed Consent Form (ICF) prior to any study-related activities
Benralizumab has been initiated within 7 days prior to study enrollment or is planned to be initiated within 7 days after enrollment (in the latter case, provided that the decision to prescribe benralizumab is made prior to the decision to enroll the patient in the study).
Benralizumab treatment within the 12 months prior to study enrollment and up to 8 days before enrollment
Previous participation (in the 12 months before enrollment), current participation or plan to participate within the follow up period to any other clinical trial.
Contraindication to benralizumab as per current Summary of Product Characteristics (SmPC).
Pregnant or lactating women.
Severe eosiniphilic asthma patients treated with benralizumab as per clinical practices
Cohort
Prospective
benralizumab
Biological/Vaccine30mg s.c. as per SmPC
Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition
Number and percentage of patient who met the 4 remission criteria (complete or partial) at 12 months and maintained up to 24months
Number and percentage of patients achieving the criteria for clinical remission
Number and percentage of patient with the criteria for complete or partial remission according to the following criteria: No need to use OCS; Absence of asthma symptoms (ACT score from 20/25 to 25/25); Absence of asthma exacerbations; Stable lung function (FEV1 decline of no more than 100 mL).
Rate of any and SA exacerbations
annualized exacerbations rate
Mean change in Asthma Control Test (ACT) score
mean (SD) changes (min - max) overtime in ACT score
Mean changes in Asthma Control Questionnaire (ACQ) score
mean (SD) changes (min - max) overtime in ACQ score
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