Bulur Isil, Bulbul Baskan Emel, Ozdemir Mustafa, Balevi Ali, Kocatürk Göncü Emek, Altunay Ilknur, Gönül Müzeyyen, Ergin Can, Ertam İlgen, Erdoğan Hilal Kaya, Bilgin Muzaffer, Mustafa Teoman Erdem
Department of Dermatology, Faculty of Medicine, Maltepe University, Istanbul, Turkey.
Department of Dermatology, Faculty of Medicine, Uludağ University, Bursa, Turkey.
Acta Dermatovenerol Alp Pannonica Adriat. 2018 Sep;27(3):121-126.
This study used real-world data to evaluate the effectiveness and reliability of omalizumab in treating recalcitrant chronic spontaneous urticaria in Turkish patients.
Study data were collected retrospectively from eight tertiary-care hospitals in Turkey. This study included 132 patients with chronic spontaneous urticaria that were resistant to H1 antihistamine treatment in a dose up to four times the licensed dose and were treated with 300 mg/month of omalizumab for 6 months.
The mean weekly urticarial activity score (UAS7) after omalizumab treatment improved significantly compared to the pre-treatment score (p < 0.001). Treatment response was detected primarily in the 1st and 2nd months after treatment. No significant association was observed between omalizumab's treatment effectiveness and disease-related parameters or laboratory data. The mean dermatology life quality index was 23.12 ± 6.15 before treatment and decreased to 3.55 ± 3.60 6 months after treatment (p < 0.001). No side effects were reported in 89.4% (118) of the patients.
This study showed that UAS7 decreased significantly and quality of life improved in omalizumab-treated patients. Moreover, treatment effectiveness was mainly observed in the first 2 months after treatment. However, no association was observed between omalizumab treatment effectiveness and disease-related parameters or laboratory data.
本研究使用真实世界数据评估奥马珠单抗治疗土耳其患者顽固性慢性自发性荨麻疹的有效性和可靠性。
研究数据从土耳其的八家三级医疗机构回顾性收集。本研究纳入了132例慢性自发性荨麻疹患者，这些患者对高达许可剂量四倍的H1抗组胺药治疗耐药，并接受每月300mg奥马珠单抗治疗6个月。
与治疗前评分相比，奥马珠单抗治疗后的平均每周荨麻疹活动度评分（UAS7）显著改善（p<0.001）。治疗反应主要在治疗后的第1个月和第2个月检测到。未观察到奥马珠单抗的治疗效果与疾病相关参数或实验室数据之间存在显著关联。治疗前平均皮肤病生活质量指数为23.12±6.15，治疗6个月后降至3.55±3.60（p<0.001）。89.4%（118例）的患者未报告副作用。
本研究表明，接受奥马珠单抗治疗的患者UAS7显著降低，生活质量得到改善。此外，治疗效果主要在治疗后的前2个月观察到。然而，未观察到奥马珠单抗治疗效果与疾病相关参数或实验室数据之间存在关联。
