ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab

AstraZeneca217 enrolled

Overview

This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program or as per normal clinical practice in Italy.

A retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation: in fact, since the Italian Sampling Program on benralizumab was active since July 2018, clinical data on patients exposed to benralizumab are already available. No treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. In order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.

Study Type

OBSERVATIONAL

Enrollment

217

Conditions

Severe Asthma

Interventions

No interventionOTHER

Patients currently in treatment with benralizumab as per approved indication and clinical practice

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date"). 2. Patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment). 3. Patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice. 4. Patients who signed the informed consent and privacy form at enrollment visit. 5. Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date"). Exclusion Criteria: 1. Patients who, during the observation period, received benralizumab in a clinical experimental trial. 2. Patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.

Locations (18)

Research Site

Acquaviva delle Fonti, Italy

Research Site

Bergamo, Italy

Research Site

Cassano Murge, Italy

Outcomes

Primary Outcomes

key features at benralizumab treatment start)

Total IgE and eosinophils count in peripheral blood as measured at index date Lung function assessments Presence of comorbidities Previous severe exacerbations in the 12 months before index date. Previous treatments with biologics for asthma before index date. Maintenance asthma treatment(s) ongoing at index date.

Time frame: At baseline

Secondary Outcomes

severe exacerbations during benralizumab treatment

Proportion of patients experiencing at least 1 severe exacerbation during benralizumab treatment. Severe exacerbation incidence rate during benralizumab treatment, calculated as the number of patients with at least one exacerbation occurred during benralizumab treatment (cases) divided by the person-time at risk considering the duration of observation while the patient was receiving benralizumab. Annual severe exacerbation rate, which will be calculated as the ratio between the total number of severe exacerbations occurred in the sample and the total number of person-years (i.e. the actual time-at-risk that all evaluable patients contributed to the study while they were in treatment with benralizumab).

Time frame: at 16 weeks

ICS and OCS change during benralizumab treatment

ICS dose change of any extent Change of OCS dose (final dose\* with respect to index date; if applicable)

Time frame: at 16 weeks

IgE and eosinophils count during benralizumab treatment, and changes over time with respect to benralizumab treatment start

Descriptive statistics of total IgE and eosinophils count in peripheral blood as measured at the time points specified. Descriptive statistics of intra-patient changes over time in total IgE and eosinophils count in peripheral blood, at each time points specified with respect to index date (according to data availability).

Time frame: at 16 weeks

lung function parameters during benralizumab treatment, and changes over time with respect to benralizumab treatment start

Data from ClinicalTrials.gov

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