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The aim of this study was to characterize the real-world treatment patterns of omalizumab among adult patients with chronic urticaria in China using data from a regional electronic healthcare (rEHR) database. This included assessing the frequency and proportion of prescriptions across different dosages of omalizumab in real-world clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Urticaria Cohort | Chronic urticaria patients with at least one prescription of omalizumab after March 2023 in the selected database. | ||
| Chronic Spontaneous Urticaria (CSU) Cohort | A subgroup of the Chronic Urticaria Cohort. Adult patients diagnosed with CSU with at least one prescription of omalizumab after March 2023 in the selected database. | ||
| Chronic Inducible Urticaria (CIndU) Cohort | A subgroup of the Chronic Urticaria Cohort. Adult patients diagnosed with CIndU with at least one prescription of omalizumab after March 2023 in the selected database. |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Dose of Omalizumab Per Patient-Year | Up to approximately 2 years and 10 months | |
| Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage | Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and >450 mg. | Up to approximately 2 years and 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Dose of Omalizumab Per Patient-Year by Calendar Year | Calendar years: 2023, 2024, and 2025. | 1 year |
| Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage and Calendar Year |
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Inclusion criteria:
Patients with at least one diagnosis of chronic urticaria during the study period. A chronic urticaria diagnosis is defined as including "chronic urticaria" but without any rule-out terms in the diagnosis name.
Patients treated with omalizumab during the identification period. The date of first omalizumab prescription is defined as the index date.
Patients aged 18 years or older at index.
Patients with at least one medical record ≥12 months prior to index date.
Additional inclusion criterion for patients included in healthcare resource utilization (HCRU) outcomes:
Patients with at least one medical record ≥12 months post index date.
Exclusion criteria:
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Adult patients diagnosed with chronic urticaria with at least one prescription of omalizumab in the database.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Shanghai | 201203 | China |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D000094482 | Chronic Inducible Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and >450 mg. Calendar years: 2023, 2024, and 2025.
| 1 year |
| Time to Omalizumab Treatment Discontinuation | Up to approximately 2 years and 10 months |
| Number and Percentage of Patients Re-treated With Omalizumab After Omalizumab Discontinuation | Up to approximately 2 years and 10 months |
| Number and Percentage of Patients Re-treated With Other Urticaria-related Treatment After Omalizumab Discontinuation by Type of Medication | Up to approximately 2 years and 10 months |
| Time From Omalizumab Discontinuation to Re-treatment | Up to approximately 2 years and 10 months |
| Duration of Omalizumab Re-treatment | Up to approximately 2 years and 10 months |
| Number and Percentage of Patients by Concomitant Treatment With Omalizumab | Concomitant treatment includes:
| Up to approximately 2 years and 10 months |
| Number of Patients by Demographic Category | Demographics include age and gender. | Baseline |
| Number of Patients by Clinical Characteristic | Clinical characteristics include:
| Baseline |
| Number of Patients by Type of Treatment Used Before Omalizumab | Baseline |
| Number of AH Drugs Used Prior to Omalizumab Initiation | Baseline |
| Time From AH Initiation to Omalizumab Initiation | Baseline |
| Time From Other Urticaria-related Medication Initiation to Omalizumab Initiation | Baseline |
| Number of Medicine Switches Prior to Omalizumab Initiation | Baseline |
| Number of All-cause Healthcare Visits Prior to Omalizumab Initiation | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Number of Urticaria-related Healthcare Visits Prior to Omalizumab Initiation | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Number of Angioedema-related Inpatient Admissions Prior to Omalizumab Initiation | 12 months |
| Number of All-cause Healthcare Visits After Omalizumab Initiation | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Number of Urticaria-related Healthcare Visits After Omalizumab Initiation | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Number of Angioedema-related Inpatient Admissions After Omalizumab Initiation | 12 months |
| Duration of Inpatient Admissions Prior to Omalizumab Initiation | Admissions include all-cause and urticaria-related inpatient admissions. | 12 months |
| Duration of Inpatient Admissions After Omalizumab Initiation | Admissions include all-cause and urticaria-related inpatient admissions. | 12 months |
| Cost for All-cause Healthcare Visits Prior to Omalizumab Initiation | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Cost for Urticaria-related Healthcare Visits Prior to Omalizumab Initiation | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Cost for All-cause Healthcare Visits After Omalizumab Initiation | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Cost for Urticaria-related Healthcare Visits After Omalizumab Initiation | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. | 12 months |
| Cost for Urticaria-related Medications Prior to Omalizumab Initiation | 12 months |
| Cost for Urticaria-related Medications After Omalizumab Initiation | 12 months |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |