Kalkan Fikriye, Yeşillik Sait, Demirel Fevzi, Sönmez Ezgi, Balaban Yasemin, İnan Mustafa İlker, Kartal Özgür
Department of Immunology and Allergy, University of Health Sciences, Gulhane Training and Research Hospital, Ankara, Turkey.
Department of Immunology and Allergy, University of Health Sciences, Gulhane Training and Research Hospital, Ankara, Turkey.
An Bras Dermatol. 2025 Jan-Feb;100(1):31-37. doi: 10.1016/j.abd.2024.02.006. Epub 2024 Nov 5.
Chronic spontaneous urticaria (CSU) is a clinical condition that affects patients quality of life. Omalizumab is preferred in antihistamines resistant CSU cases. Urticaria activity score-7 (UAS-7) is a scale that shows the severity of the disease.
The authors aimed to compare the long-term (60 months) efficacy and side effects of 150 mg and 300 mg doses of omalizumab in patients with CSU.
108 patients followed up at the clinic with the diagnosis of CSU were included. Omalizumab was started in patients who were resistant to conventional CSU treatment. Two groups were formed to receive 150 mg and 300 mg doses of omalizumab. Urticaria activity score (UAS-7), antihistamine usage, time to achieve disease-free stage, relapse after treatment, and side effects of omalizumab treatment were compared in the two groups.
There were no statistically significant differences between the groups regarding basal characteristics and laboratory findings. Average follow-up time was sixty months. UAS-7 scores were similar in the follow-up. There were no adverse events in both groups.
Retroactive design and single-center nature to reach a more significant number of patients. Lack of patients receiving the lowest dose 75 mg and the highest dose 600 mg of omalizumab. Absence of total body mass indexes of all patients. Besides, the use of distinct drugs may contribute to non confident results and is another limitation of this study.
Since there is no significant difference between 150-300 mg omalizumab doses regarding long-term treatment efficacy and side effects in CSU patients, starting treatment with a 150 mg dose may be suitable. In patients who do not respond to 150 mg, the omalizumab dose can be increased to 300 mg. It will prevent unpredictable dose and time-dependent complications and will be a cost-effective approach even in strong economies.
慢性自发性荨麻疹（CSU）是一种影响患者生活质量的临床病症。对于抗组胺药耐药的CSU病例，奥马珠单抗是首选药物。荨麻疹活动度评分-7（UAS-7）是一种显示疾病严重程度的量表。
作者旨在比较150mg和300mg剂量的奥马珠单抗在CSU患者中的长期（60个月）疗效和副作用。
纳入108例在诊所确诊为CSU并接受随访的患者。奥马珠单抗用于对常规CSU治疗耐药的患者。将患者分为两组，分别接受150mg和300mg剂量的奥马珠单抗。比较两组的荨麻疹活动度评分（UAS-7）、抗组胺药使用情况、达到无病阶段的时间、治疗后的复发情况以及奥马珠单抗治疗的副作用。
两组在基础特征和实验室检查结果方面无统计学显著差异。平均随访时间为60个月。随访期间UAS-7评分相似。两组均未出现不良事件。
采用回顾性设计且为单中心研究，以纳入更多患者。缺乏接受最低剂量75mg和最高剂量600mg奥马珠单抗的患者。未提供所有患者的总体重指数。此外，使用不同药物可能导致结果不可靠，这是本研究的另一个局限性。
由于150 - 300mg剂量的奥马珠单抗在CSU患者的长期治疗疗效和副作用方面无显著差异，起始治疗采用150mg剂量可能是合适的。对于对150mg无反应的患者，可将奥马珠单抗剂量增加至300mg。这将避免不可预测的剂量和时间依赖性并发症，即使在经济发达地区也是一种具有成本效益的方法。
