Efficacy and Safety of Omalizumab in Chinese Children Under 12 with Chronic Urticaria

Overview

This retrospective case series of 13 Chinese pediatric patients under 12 years with refractory chronic urticaria demonstrated rapid symptom improvement and excellent safety with omalizumab treatment. Significant reduction in disease activity was observed within one week, with most patients achieving well-controlled disease by week 4.

Background

Chronic urticaria (CU) in children is characterized by recurrent wheals and/or angioedema lasting more than six weeks, with chronic spontaneous urticaria (CSU) being the most common subtype. First-line treatment involves second-generation H1-antihistamines, but many children remain symptomatic despite high-dose therapy. Omalizumab, an anti-IgE monoclonal antibody, is approved for patients aged 12 years and older, but data on its use in younger children are limited. This study aimed to evaluate the efficacy and safety of omalizumab in Chinese children under 12 with CU.

Data Highlights

Key Findings

• All 13 pediatric patients showed rapid clinical improvement within one week after the initial omalizumab dose.
• Oral antihistamines were discontinued in all patients within four weeks of treatment initiation.
• The median UAS7 score significantly decreased from 20.0 at baseline to 4.0 at week 4 (p = 0.001).
• Eleven patients (84.6%) achieved well-controlled disease (UAS7 ≤6) by week 4.
• No adverse events were reported across 74 omalizumab injections, indicating excellent tolerability.
• Nearly half of the cohort had comorbid allergic conditions such as atopic dermatitis, allergic rhinitis, or asthma.

Clinical Implications

Omalizumab appears to be an effective and safe second-line treatment option for children under 12 years with chronic urticaria refractory to high-dose antihistamines. Rapid symptom control and the ability to discontinue oral antihistamines within a month can improve patient quality of life. Clinicians should consider omalizumab for younger pediatric patients with moderate-to-severe CU, especially those with comorbid allergic diseases.

Conclusion

This case series supports the use of omalizumab as a well-tolerated and efficacious therapy for chronic urticaria in Chinese children under 12 years, demonstrating rapid symptom relief and significant disease control. Further larger studies are warranted to confirm these findings.

References

1. Second Hospital of Hebei Medical University, 2024 -- Efficacy and Safety of Omalizumab in Chinese Pediatric Patients Under 12 with Chronic Urticaria: A Case Series Analysis