Efficiency of Adding Omalizumab to Standard Therapy for Children with Recurrent Spontaneous Urticaria: Comparative Observational Study

Background. Recurrent spontaneous urticaria (RSU) is rare in children, thus, it is debilitating condition that always requires treatment. There are several limitations on the drugs use in children with RSU. Omalizumab is the effective medication for achieving the control of RSU, used in adolescents over 12 years of age.

The aim of the study is to compare the efficiency of various approaches for RSU management in children.

Methods. The three-year comparative study of patients with RSU aged from 1 to 17 years managed only with 2nd generation antihistamines in standard or increased doses for at least 3 months and patients managed in addition to standard treatment with omalizumab (300 mg once in 4 weeks subcutaneously) was conducted. The essential treatment outcomes are achieving control of the disease (UAS7 = 0) in 6 months and remission maintaining after 36 months of observation. Additional outcomes are decrease in the number of aggravations that required the use of glucocorticosteroids (GCS) during 3 years of followup; analysis of treatment outcomes of patients with severe urticaria in subgroups (including UAS7 levels).

Results. The frequency of disease control (UAS7 = 0) by 6 months of therapy was significantly higher in patients of the omalizumab group — 76%, in the second group — 0%. The UAS7 in the omalizumab group was 0 (0; 1) points, in the group of patients on standard therapy — 13 (10; 16) points (p < 0.05). Remission was observed in 53% of patients (9 people) in the omalizumab group in 36 months, in the comparison group — in 32% (13 people), p = 0.129; UAS7 in the omalizumab group was 0 (0; 8.5) points, in the comparison group — 8 (0; 13) points, p = 0.076. The use of systemic GCS for acute treatment decreased during 3 years of follow-up: in the omalizumab group — from 41 to 5.9%, in the group on 2nd generation antihistamines — from 46 to 19% (p = 0.258). The result of subgroup analysis was similar.

Conclusion. Adding omalizumab to standard RSU therapy makes it possible to achieve control of the disease reliably faster in most cases. There was gradual decrease in RSU activity in the group on standard therapy during the 3-year follow-up: spontaneous remission was mentioned in 32% of children within 3 years.

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