Chronic Urticaria
Conditions
Keywords
Chronic Urticaria, Chronic Spontaneous Urticaria, Chronic Inducible Urticaria, Omalizumab, Dosing pattern, Treatment pattern, Healthcare resource utilization
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patients treated with omalizumab during the identification period. The date of first omalizumab prescription is defined as the index date. 3. Patients aged 18 years or older at index. 4. 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: 5. Patients with at least one medical record ≥12 months post index date.
Exclusion criteria
1. Patients with a diagnosis of allergic asthma during the study period. 2. Patients without any dosing information (raw or derived) for omalizumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Dose of Omalizumab Per Patient-Year | Up to approximately 2 years and 10 months | — |
| Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage | Up to approximately 2 years and 10 months | Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and \>450 mg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Dose of Omalizumab Per Patient-Year by Calendar Year | 1 year | Calendar years: 2023, 2024, and 2025. |
| Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage and Calendar Year | 1 year | Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and \>450 mg. Calendar years: 2023, 2024, and 2025. |
| 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 | Up to approximately 2 years and 10 months | Concomitant treatment includes: * Antihistamines (AH) * Traditional Chinese medicine (TCM)-Lei-Gong-Teng * Other TCM * Corticosteroids |
| Number of Patients by Demographic Category | Baseline | Demographics include age and gender. |
| Number of Patients by Clinical Characteristic | Baseline | Clinical characteristics include: * Insurance type * Department (dermatology, allergy, others) * Types of chronic urticaria (CSU, CIndU, both CSU and CIndU) * Presence of angioedema * Charlson comorbidity index score * Laboratory test results * Comorbidities |
| 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 | 12 months | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Number of Urticaria-related Healthcare Visits Prior to Omalizumab Initiation | 12 months | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Number of Angioedema-related Inpatient Admissions Prior to Omalizumab Initiation | 12 months | — |
| Number of All-cause Healthcare Visits After Omalizumab Initiation | 12 months | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Number of Urticaria-related Healthcare Visits After Omalizumab Initiation | 12 months | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Number of Angioedema-related Inpatient Admissions After Omalizumab Initiation | 12 months | — |
| Duration of Inpatient Admissions Prior to Omalizumab Initiation | 12 months | Admissions include all-cause and urticaria-related inpatient admissions. |
| Duration of Inpatient Admissions After Omalizumab Initiation | 12 months | Admissions include all-cause and urticaria-related inpatient admissions. |
| Cost for All-cause Healthcare Visits Prior to Omalizumab Initiation | 12 months | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Cost for Urticaria-related Healthcare Visits Prior to Omalizumab Initiation | 12 months | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Cost for All-cause Healthcare Visits After Omalizumab Initiation | 12 months | All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Cost for Urticaria-related Healthcare Visits After Omalizumab Initiation | 12 months | Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits. |
| Cost for Urticaria-related Medications Prior to Omalizumab Initiation | 12 months | — |
| Cost for Urticaria-related Medications After Omalizumab Initiation | 12 months | — |
Countries
China
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed