Meta-Analysis Examines Omalizumab for Urticaria in Children

Medscape

26-06-2025

TOPLINE:
Omalizumab yielded a high response rate and had an acceptable safety profile in children with chronic spontaneous urticaria (CSU), including those younger than 12 years, a meta-analysis showed. Clinicians should monitor for rare adverse reactions such as serum sickness, the researchers said.
METHODOLOGY:
Since 2014, omalizumab, a recombinant monoclonal anti-immunoglobulin E antibody, has been approved by the FDA for the treatment of CSU in patients aged 12 years or older. Safety and efficacy data in children, particularly those younger than 12 years, have been limited.
Researchers conducted a systematic review and meta-analysis of 36 studies that assessed the efficacy and safety of omalizumab in children with CSU.
TAKEAWAY:
In a pooled analysis of 16 studies, the proportion of children whose symptoms improved with omalizumab was 88% (95% CI, 80.7%-95.2%). In a pooled analysis of 12 studies, 51% (95% CI, 32.7%-69.2%) had a complete resolution of symptoms.
Data from seven studies demonstrated a significant reduction in symptoms as measured by Urticaria Activity Score over 7 days (UAS7).
Adverse events occurred in 3.4% of patients treated with omalizumab, including urticaria, angioedema, headaches, fatigue, flu-like symptoms, or mild joint pain.
Of 21 children younger than 12 years treated with omalizumab, 18 had complete resolution of symptoms (one later experienced a relapse after stopping treatment). The others had well-controlled symptoms or mild itching.
In one case, a 12-year-old patient 'experienced malaise, joint pain, cervical and axillary lymphadenopathy, and mild thrombocytopenia with each injection, later diagnosed as serum sickness,' according to the report.
IN PRACTICE:
'The findings of this meta-analysis support the efficacy and safety of omalizumab in pediatric patients, demonstrating its potential as a safe treatment option for antihistamine-resistant CSU,' the study authors wrote.
SOURCE:
Omar Alomari, with the University of Health Sciences, Istanbul, Turkey, was the corresponding author of the study, which was published online on June 23 in Pediatric Allergy and Immunology.
LIMITATIONS:
This study relied on UAS7 to assess efficacy. The researchers had insufficient data to identify predictors of omalizumab response.
DISCLOSURES:
The authors reported having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.