D2.359 - Safety and effectiveness of Omalizumab for Cold Urticaria in pediatric age

Cold Urticaria (ColdU) is a chronic inducible urticaria triggered by cold exposure, that can significantly affect quality of life. Treatment typically follows a stepwise approach with cold exposure avoidance and with escalating doses of nonsedating antihistamines. Omalizumab (OMA), an anti-IgE monoclonal, approved for chronic spontaneous urticaria, has been reported to be safe and effective in adults with ColdU, but data in pediatric patients is still lacking.

This report describes an 11-year-old boy with house dust mites allergic rhinitis who began experiencing frequent episodes of pruritic maculopapular lesions, edema of the hands, and auricles, at the age of 10. These episodes were linked to exposure to cold water, for example in water sports, pool and sea; and cold weather, resolving within one hour without treatment and leaving no residual lesions. He denied spontaneous lesions, systemic symptoms, Raynaud’s phenomenon, or musculoskeletal complaints.

The cold stimulation test (CST) was positive (fig. 1). Analytical studies included blood count, sedimentation rate, protein electrophoresis, complement system, cryoglobulins and autoimmune study, which were unremarkable. The patient’s total IgE was of 233 KU/L.

Antihistamine treatment was initiated and escalated until 40mg of bilastine, with no improvement. Despite this, symptoms persisted almost daily, significantly affecting the boy's quality of life and causing social discomfort.

At the age of 11, OMA 150 mg was initiated every 4 weeks. After the first dose, a significant reduction in symptoms was observed. Four weeks later, the CST showed only erythema without papules (fig.2). After 5 months, the boy was completely asymptomatic while practicing water sports or when exposed to cold weather requiring no antihistamines, and no complications were reported.

This case demonstrates that off-label OMA treatment led to symptom resolution and improved quality of life in a child under 12 years with antihistamine-resistant ColdU, highlighting its safety and efficacy as an adjunct therapy.