Cekic Sukru, Canitez Yakup, Ozceker Deniz, Uysal Pınar, Ozdemir Oner, Filiz Serkan, Bologur Hamit, Karali Yasin, Yuksel Hale, Sapan Nihat
Department of Pediatric Allergy and Clinical Immunology, Bursa Uludag University School of Medicine, Bursa, Turkey,
Department of Pediatric Allergy and Clinical Immunology, Bursa Uludag University School of Medicine, Bursa, Turkey.
Int Arch Allergy Immunol. 2025 Jun 4:1-10. doi: 10.1159/000545336.
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.
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).
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.
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.
关于不同奥马珠单抗给药策略在儿童慢性自发性荨麻疹（CSU）中的有效性，现有数据有限。本研究旨在基于真实生活数据，调查不同剂量起始的奥马珠单抗在儿童和青少年CSU患者中的疗效。
本研究在土耳其的五个学术医学中心进行。患者数据从其病历资料中获取。37例（60.7%）患者（第1组）起始奥马珠单抗治疗的剂量为每4周150mg，24例（39.3%）患者（第2组）起始剂量为300mg。
患者的平均年龄为14.4±2.6岁（6.3 - 18岁），女性与男性比例为2.2（42/19）。第1组和第2组的平均初始UAS7评分之间无差异（分别为34±8.8和34.6±9.1）（p = 0.854）。在治疗期间，第1组和第2组分别有75.7%（n = 28）和87.5%（n = 21）的患者达到无荨麻疹或病情得到良好控制的状态（p = 0.334）。第2组达到无荨麻疹或病情得到良好控制状态的时间比第1组短（中位数：分别为1个月[1 - 3个月]和2个月[1 - 4个月]）（p = 0.036）。在研究期间，第1组和第2组分别有59.5%（n = 22）和87.5%（n = 21）的患者达到无荨麻疹状态（p = 0.023）。第1组有7例患者（31.8%）和第2组有2例患者（9.5%）出现复发（p = 0.132）。在最后一次评估时，第2组无荨麻疹的患者（83.3%，n = 20）比第1组（48.6%，n = 18）多（p = 0.008）。有1例患者在首剂后的前24小时内出现与奥马珠单抗相关的荨麻疹加重，但该并发症未再次出现。除1例患者出现头晕外，在我们的患者队列中未观察到其他不同的副作用。
奥马珠单抗是儿童CSU的一种有效且可靠的治疗选择。通过每4周300mg的治疗方案起始治疗，可在更短时间内达到无荨麻疹或病情得到良好控制的状态。尽管在大多数情况下可能需要增加该剂量，但相当一部分患者使用每4周150mg的剂量也可实现病情控制。
