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

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

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 Overview

• Status: Completed
• Conditions: Chronic Urticaria

• Study Type: Observational
• Enrollment (Actual): 3485

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201203
    • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with chronic urticaria with at least one prescription of omalizumab in the database.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: Antihistamines (AH); Traditional Chinese medicine (TCM)-Lei-Gong-Teng; Other TCM; Corticosteroids	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: 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	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Actual): March 23, 2026
• Study Completion (Actual): March 23, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Urticaria; Healthcare resource utilization; Omalizumab; Chronic Spontaneous Urticaria; Treatment pattern; Chronic Inducible Urticaria; Dosing pattern
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria; Chronic Inducible Urticaria
• Other Study ID Numbers: CIGE025ECN02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO