Cubiró X, Spertino J, Rozas-Muñoz E, Serra-Baldrich E, Puig L
Departamento de Dermatología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, España.
Departamento de Dermatología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, España.
Actas Dermosifiliogr (Engl Ed). 2019 May;110(4):289-296. doi: 10.1016/j.ad.2018.09.009. Epub 2018 Oct 22.
The efficacy of omalizumab in the treatment of chronic spontaneous urticaria has been demonstrated in phase iii clinical trials, but limited information is available regarding real-life effectiveness using the weekly Urticarial Activity Score (UAS7). The aim of the study was to assess clinical response (UAS7≤6) and complete response (UAS7=0) rates at weeks 12 and 24 in a real-life cohort and to identify possible predictors of response to omalizumab.
Clinical records of consecutive patients with moderate-to-severe chronic spontaneous urticaria (UAS≥16) treated with omalizumab at a university-affiliated reference dermatology department in Barcelona, Spain, from February 2014 to September 2017 were retrospectively reviewed. UAS7 values and patients' evolution were assessed according to a predefined protocol. Statistical analysis of data was done using SPSS 18 statistical package (SPSS 18 Inc., Chicago, IL, USA) software.
Forty-eight patients were included in the study. All of them completed at least 24-weeks of treatment and follow-up. At week 12, clinical response rates (UAS7<6) were 70.8% and complete response rates (UAS7=0) were 47.9%. At week 24, clinical response rates were 64.6% and complete response rates were 52.1%.
with long-term urticaria (≥18 months' duration) were less likely to achieve a clinical response at week 12 (odds ratio: 0.25; 95% confidence interval 0.06-0.96). Previous immunosuppressive treatment tended to be associated with a lower probability of complete response at week 12 (odds ratio: 0.27 95% confidence interval: 0.07-1.02). H1-antihistamine treatment was associated with lower probability of response at week 24 (odds ratio: 0.1 95% 95% confidence interval: 0.01-0.88) CONCLUSIONS: The effectiveness and safety of omalizumab in real life are similar to efficacy and safety in clinical trials. Duration of disease, previous immunosuppressive therapy and requirement for concomitant H1-antihistamine treatment may be helpful in predicting response to omalizumab treatment.
奥马珠单抗治疗慢性自发性荨麻疹的疗效已在III期临床试验中得到证实，但关于使用每周荨麻疹活动度评分（UAS7）的实际疗效的信息有限。本研究的目的是评估在一个实际队列中第12周和第24周时的临床反应率（UAS7≤6）和完全反应率（UAS7=0），并确定奥马珠单抗反应的可能预测因素。
回顾性分析2014年2月至2017年9月在西班牙巴塞罗那一家大学附属参考皮肤科接受奥马珠单抗治疗的中度至重度慢性自发性荨麻疹（UAS≥16）连续患者的临床记录。根据预定义方案评估UAS7值和患者的病情进展。使用SPSS 18统计软件包（美国伊利诺伊州芝加哥市SPSS 18公司）对数据进行统计分析。
48例患者纳入研究。所有患者均完成了至少24周的治疗和随访。在第12周时，临床反应率（UAS7<6）为70.8%，完全反应率（UAS7=0）为47.9%。在第24周时，临床反应率为64.6%，完全反应率为52.1%。
患有长期荨麻疹（病程≥18个月）的患者在第12周时获得临床反应的可能性较小（优势比：0.25；95%置信区间0.06-0.96）。既往免疫抑制治疗在第12周时获得完全反应的概率往往较低（优势比：0.27；95%置信区间：0.07-1.02）。H1抗组胺药治疗与第24周时反应概率较低相关（优势比：0.1；95%置信区间：0.01-0.88）。结论：奥马珠单抗在实际应用中的有效性和安全性与临床试验中的疗效和安全性相似。疾病持续时间、既往免疫抑制治疗以及对H1抗组胺药联合治疗的需求可能有助于预测奥马珠单抗治疗的反应。
