The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice.
This non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice. This study was designed to use secondary data from medical charts of 25 hospitals. Medical records were reviewed to collect information such as demographics, clinical characteristics, treatment patterns, effectiveness, and AEs for retrospective analysis. Patients with allergic asthma aged 6 -\<12 years treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction.
Study Type
OBSERVATIONAL
Enrollment
200
Patients with confirmed diagnosis of allergic asthma, who were prescribed omalizumab
Novartis Investigative Site
East Hanover, New Jersey, United States
Proportion of patients who responded to omalizumab
The responders were defined as patients with: 1. Investigator's Global Evaluation of Treatment Effectiveness (GETE) are Excellent or Good; or 2. C-ACT2 improvement ≥3 points before and after omalizumab treatment
Time frame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Number of adverse events and serious adverse events
To evaluate safety of omalizumab among children with allergic asthma in China.
Time frame: Throughout the study, approximately 2 years
Proportion of patients with positive investigator's Global Evaluation of Treatment Effectiveness (GETE)
Positive investigator's GETE is defined as restrospectively evaluated GETE are Excellent or Good.
Time frame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in moderate-to-severe Asthma exacerbation
Moderate-to-severe asthma exacerbation is defined as worsening of asthma symptoms requiring doubling of baseline ICS dose and/or treatment with rescue systemic corticosteroids for ≥ 3 days.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in severe Asthma exacerbation
Severe asthma exacerbation is defined as requiring ER admission /hospitalization/ICU admission/mechanical ventilation with systemic corticosteroids for ≥ 3 days.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Average change from baseline in daily inhaled corticosteroids (ICS) dose
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The dosage of inhaled corticosteroids (ICS) was reported to evaluate the effectiveness of omalizumab among children aged 6 -\<12 years with allergic asthma in China.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Average change from baseline in daily oral corticosteroids (OCS) dose
The dosage of oral corticosteroids (OCS) was reported to evaluate the effectiveness of omalizumab among children aged 6 -\<12 years with allergic asthma in China.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Percentage of patients that successfully stopped Oral Corticosteroids
Percentage of patients that successfully stopped Oral Corticosteroids after 4 to 6 months of treatment were reported
Time frame: After 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Lung function using Forced Expiratory Volume in 1 Second (FEV1)
Lung function was assessed using Forced Expiratory Volume in 1 Second (FEV1) to evaluate the effectiveness of omalizumab among children aged 6 -\<12 years with allergic asthma in China. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in FEV1% pred
Ratio of patient's actual results compared to predicted normal values, expressed as a percentage.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in FEV1/FVC
The FEV1/FVC ratio indicates how much air you can forcefully exhale.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) is an objective measure of how well the lungs are functioning and can measure airway narrowing.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Change from baseline in Maximal mid-expiratory flow (MMEF)
Maximal mid-expiratory flow (MMEF) is a spirometric parameter reflecting airflow of large and small airways.
Time frame: Baseline, after 4-6 months of treatment (Between July 6, 2018 to September 30, 2020)
Number of patients who received the recommended dosage instructions during the identification period
To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Time frame: Throughout the study, approximately 2 years
Median time to discontinuation of the treatment
To describe the treatment pattern of Xolair among children with allergic asthma in China.
Time frame: Throughout the study, approximately 2 years
Percentage of patients using Omalizumab for more than 4, 16, 24 and 52 weeks
To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Time frame: Week 4, 16, 24 and 52 (Between July 6, 2018 to September 30, 2020)
Number of patients who discontinued omalizumab
To describe the treatment pattern of omalizumab among children with allergic asthma in China.
Time frame: Throughout the study, approximately 2 years