The Efficacy of Different Dosing Regimens of Omalizumab in Children and Adolescents with Chronic Spontaneous Urticaria Based on Real-Life Data

Abstract

Introduction: Limited data are available regarding the effectiveness of different omalizumab-dosing strategies in childhood chronic spontaneous urticaria (CSU). This study aimed to investigate the efficacy of omalizumab initiated at different doses in children and adolescents with CSU based on real-life data.

Methods: This study was conducted at five academic medical centers in Turkey. Patient data were obtained from their file data. Omalizumab treatment was initiated at a dose of 150 mg every 4 weeks in 37 (60.7%) patients (group 1) and 300 mg in 24 (39.3%) patients (group 2).

Results: The mean age of patients was 14.4 ± 2.6 years (6.3-18 years), and female-to-male ratio was 2.2 (42/19). There was no difference between the mean initial UAS7 scores of groups 1 and 2 (34 ± 8.8 and 34.6 ± 9.1, respectively) (p = 0.854). Groups 1 and 2 achieved an urticaria-free or well-controlled status at rates of 75.7% (n = 28) and 87.5% (n = 21), respectively, during the treatment period (p = 0.334). Group 2 achieved urticaria-free or well-controlled status in a shorter time than group 1 (median: 1 month [1-3 months] and median: 2 months [1-4 months], respectively) (p = 0.036). The rate of patients who achieved urticaria-free status during the study period was 59.5% (n = 22) and 87.5% (n = 21) in groups 1 and 2, respectively (p = 0.023). Seven patients in group 1 (31.8%) and 2 patients in group 2 (9.5%) experienced recurrence (p = 0.132). At the last evaluation, more patients in group 2 (83.3%, n = 20) were urticaria-free than in group 1 (48.6%, n = 18) (p = 0.008). A patient had an exacerbation of urticaria associated with omalizumab within the first 24 h of the first dose, but this complication was not repeated. Other than dizziness in 1 patient, no different side effects were seen in our cohort of patients.

Conclusion: Omalizumab is an effective and reliable treatment option for childhood CSU. Urticaria-free or well-controlled status can be achieved in a shorter time by initiating treatment with a 300 mg/4 week regimen. Although this dose may need to be increased in most cases, control can be achieved with a dose of 150 mg/4 weeks in a considerable number of patients.

Keywords: Children; Chronic spontaneous urticaria; Omalizumab.