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Management of Pediatric Chronic Spontaneous Urticaria: Current Evidence and Emerging Therapies
Micol Tedeschi1, Maria Gnarra Buethe2,3,4, Gian Luigi Marseglia1
1Pediatric Unit, Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Viale Camillo Golgi 19, 27100, Pavia, Italy.
Abstract:
Pediatric chronic spontaneous urticaria is a heterogeneous, mast cell-driven inflammatory disorder characterized by recurrent pruritic wheals, angioedema, or both persisting for more than 6 weeks, with a significant impact on patient and family quality of life. Although most children achieve disease control with second-generation H1-antihistamines, a substantial proportion remains symptomatic despite dose escalation and requires advanced treatment. Based on a structured search of PubMed/MEDLINE, Google Scholar, ClinicalTrials.gov, and regulatory sources covering publications from 2010 to 2026, this narrative review synthesizes current evidence on established and emerging therapeutic options for pediatric chronic spontaneous urticaria, with particular emphasis on age-specific efficacy, safety, regulatory status, practical treatment positioning, and the translation of adult evidence to pediatric practice. Omalizumab remains the most established second-line biologic in adolescents (aged ≥ 12 years). The recent approval of dupilumab for children aged ≥ 2 years, based on pharmacokinetic extrapolation from adult and adolescent trials, represents the first biologic option for younger children with antihistamine-refractory chronic spontaneous urticaria. Emerging therapies, including Bruton tyrosine kinase inhibitors (remibrutinib, now US Food and Drug Administration and European Commission approved for adults), anti-KIT antibodies (barzolvolimab), and Mas-related G-protein coupled receptor X2 antagonists, are expanding the therapeutic paradigm, although pediatric data remain limited. We also propose an age-adapted treatment algorithm integrating current regulatory approvals, evidence quality, and age-specific safety considerations. The availability of approved biologic therapy from 2 years of age marks a paradigm shift in this rapidly evolving field; however, dedicated pediatric trials, validated biomarkers for endotype-guided treatment, and long-term safety data in children remain critical unmet needs.
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