Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.

AstraZeneca221 enrolled

Overview

Primary Objectives: 1. To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization 2. To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation) This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in 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 in Spain, on January 1st 2019.

Study Type

OBSERVATIONAL

Enrollment

221

Conditions

Severe Asthma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (age ≥18 years) * Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller. * Patients with at least 12-month data available before index date (starting benralizumab treatment) * Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date") * Informed consent signed. Exclusion Criteria: * Patients who received benralizumab in a clinicaltrial, during the observation period.

Locations (1)

Outcomes

Primary Outcomes

Age

Specifically, at the time of taking the first dose of study drug

Time frame: Up to 12 months (Baseline period)

Gender

Specifically, at the time of taking the first dose of study drug

Time frame: Up to 12 months (Baseline period)

Smoking Habits

Time frame: Up to 12 months (Baseline period)

Age at athma diagnosis

Time frame: Up to 12 months (Baseline period)

Blood eosinophils count

Time frame: Baseline period

Total IgE

Time frame: Baseline period

Number of patients with positive Prick test

Time frame: Baseline period

FeNo

Time frame: Baseline period

Lung function (FEV1 and FVC)

Time frame: Baseline period

ACT (or ACQ) score

Asthma Control Test (ACT), the scores range from 5 to 25, with higher scores reflecting greater asthma control. Asthma Control Questionnaire (ACQ), the total score range between 0 (well controlled asthma) and 6 (extremely poorly controlled)

Time frame: Baseline period

AQLQ score

Asthma Quality of Life Questionnaire (AQLQ), it scores from 1 (minimum) to 7 (maximum) where the higher the score, the better the quality of life is

Time frame: Baseline period

Severe asthma exacerbations

Time frame: In the previous 12 months

Key comorbidities

Time frame: Baseline period

OCS-related comorbidities

Time frame: Baseline period

Concomitant asthma medications

Time frame: Baseline period

Physician office visits

Split by primary care and specialist (asthma related)

Time frame: Baseline period

Emergency room visits

Time frame: Baseline period

Hospitalisations

Number and duration

Time frame: Baseline period

Number of laboratory tests per patient

Time frame: Baseline period

Number of conventional radiology procedures per patient

Time frame: Baseline period

Number of diagnostic/therapeutic tests per patient

Asthma related only

Time frame: Baseline period

Number of spirometries per patient

Time frame: Baseline period

Number of allergy tests per patient

Time frame: Baseline period

Number of computed axial tomographies per patient

Time frame: Baseline period

Number of magnetic resonance imaging procedures per patient

Time frame: Baseline period

Asthma treatment

Including previous biologic treatment, type of treatment and reasons for discontinuation or switching

Time frame: Up to 24 months (study duration)