A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in China

Novartis Pharmaceuticals3,485 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,485

Conditions

Chronic Urticaria

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

Shanghai, China

Outcomes

Primary Outcomes

Average Dose of Omalizumab Per Patient-Year

Time frame: 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.

Time frame: Up to approximately 2 years and 10 months

Secondary Outcomes

Average Dose of Omalizumab Per Patient-Year by Calendar Year

Calendar years: 2023, 2024, and 2025.

Time frame: 1 year

Number and Percentage of Omalizumab Prescriptions by Omalizumab Dosage and Calendar Year

Omalizumab dosage includes 150 mg, 300 mg, 450 mg, and \>450 mg. Calendar years: 2023, 2024, and 2025.

Time frame: 1 year

Time to Omalizumab Treatment Discontinuation

Time frame: Up to approximately 2 years and 10 months

Number and Percentage of Patients Re-treated With Omalizumab After Omalizumab Discontinuation

Time frame: 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

Time frame: Up to approximately 2 years and 10 months

Time From Omalizumab Discontinuation to Re-treatment

Time frame: Up to approximately 2 years and 10 months

Duration of Omalizumab Re-treatment

Data from ClinicalTrials.gov

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Time frame: Up to approximately 2 years and 10 months

Number and Percentage of Patients by Concomitant Treatment With Omalizumab

Concomitant treatment includes: * Antihistamines (AH) * Traditional Chinese medicine (TCM)-Lei-Gong-Teng * Other TCM * Corticosteroids

Time frame: Up to approximately 2 years and 10 months

Number of Patients by Demographic Category

Demographics include age and gender.

Time frame: Baseline

Number of Patients by Clinical Characteristic

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

Time frame: Baseline

Number of Patients by Type of Treatment Used Before Omalizumab

Time frame: Baseline

Number of AH Drugs Used Prior to Omalizumab Initiation

Time frame: Baseline

Time From AH Initiation to Omalizumab Initiation

Time frame: Baseline

Time From Other Urticaria-related Medication Initiation to Omalizumab Initiation

Time frame: Baseline

Number of Medicine Switches Prior to Omalizumab Initiation

Time frame: Baseline

Number of All-cause Healthcare Visits Prior to Omalizumab Initiation

All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

Time frame: 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.

Time frame: 12 months

Number of Angioedema-related Inpatient Admissions Prior to Omalizumab Initiation

Time frame: 12 months

Number of All-cause Healthcare Visits After Omalizumab Initiation

All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

Time frame: 12 months

Number of Urticaria-related Healthcare Visits After Omalizumab Initiation

Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

Time frame: 12 months

Number of Angioedema-related Inpatient Admissions After Omalizumab Initiation

Time frame: 12 months

Duration of Inpatient Admissions Prior to Omalizumab Initiation

Admissions include all-cause and urticaria-related inpatient admissions.

Time frame: 12 months

Duration of Inpatient Admissions After Omalizumab Initiation

Admissions include all-cause and urticaria-related inpatient admissions.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Cost for All-cause Healthcare Visits After Omalizumab Initiation

All-cause healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

Time frame: 12 months

Cost for Urticaria-related Healthcare Visits After Omalizumab Initiation

Urticaria-related healthcare visits include inpatient admissions, outpatient visits, and emergency room visits.

Time frame: 12 months

Cost for Urticaria-related Medications Prior to Omalizumab Initiation

Time frame: 12 months

Cost for Urticaria-related Medications After Omalizumab Initiation

Time frame: 12 months