■慢性荨麻疹(CU)是一种特征为复发性荨麻疹和/或血管性水肿≥6周的疾病。关于CU的大部分数据来自西方国家,关于CU在亚洲的信息很少,非洲,和中东。
■AWARE-AMAC是24个月的预期,观察,真实世界,来自亚洲的18岁以上患者的非干预性研究,中东,和非洲(AMAC),CU对H1抗组胺药(H1-AH)难治。主要目的是描述CU的真实体验,包括临床特征,血管性水肿的存在,治疗模式(治疗类别之间的转变和治疗类别内的变化),研究者评估的疾病控制,以及对生活质量的影响。感兴趣的亚组是基线和治疗类别的CU类型(基于2013年荨麻疹指南)。除了常规实践之外,没有强制性的访问和诊断/监测程序,除了患者日记(7天荨麻疹活动评分)和患者报告的结果评估。
■当前手稿的重点是慢性自发性荨麻疹(CSU)患者,谁构成了98%的样本。患者以女性为主(69.6%为女性,平均年龄±SD39.8±13.29岁)。自当前诊断以来的时间(平均值±SD)为28.6±49.06个月。在CSU患者中,31.0%患有共病慢性诱导型荨麻疹(CINDU),46.4%有血管性水肿病史。91.9%接受H1-AH治疗(±其他治疗)。基线时最常见的处方治疗类别是任何药物/组合,不属于其他7个治疗类别,命名为“其他”(30.5%),其次是,奥马珠单抗(OMA;23.6%)和第二代H1-AH单一疗法(sgAH;15.1%)。在第12个月,患者的处方治疗类别(>15%)为OMA(23.5%)和“其他”(21.3%);19.7%接受“无药物”。在24个月,OMA(22.5%),和“其他”(17.9%)最常处方;28.6%接受“无药物”。总的来说,79.5%的患者在治疗中有某种类型的改变。在学习期间,自我报告的QoL改善增加,这反映了更好的疾病控制。
■在AMAC国家/地区,非推荐的“其他”治疗类别在CU患者的初始管理中发挥了重要作用.观察到H1-AH(±其他处理)和OMA的高使用率。在大多数患者中观察到治疗变化。从sgAH开始的治疗升级主要是通过OMA。在研究期间实现了疾病控制和QoL的改善。
■观察性研究(NA)。
UNASSIGNED: Chronic urticaria (CU) is a condition characterized by recurrent itchy hives and/or angioedema for ≥6 weeks. Most of the data about CU come from western countries with very little information available about CU in Asia, Africa, and the Middle East.
UNASSIGNED: AWARE-AMAC is a 24-month prospective, observational, real-world, non-interventional study in patients aged ≥18 years from Asia, the Middle East, and Africa (AMAC) with CU refractory to H1-antihistamines (H1-AH). The main objective was to describe the real-world experience with CU, including clinical characteristics, presence of angioedema, treatment patterns (shifts between treatment classes and changes within a treatment class), investigator-assessed disease control, and the impact on quality of life. Subgroups of interest were type of CU at Baseline and treatment class (based on 2013 urticaria guidelines). There were no mandatory visits and diagnostic/monitoring procedures additional to routine practice, except the patient diary (7-day Urticaria Activity Score) and patient reported outcome assessments.
UNASSIGNED: The focus of the current manuscript is on patients with chronic spontaneous urticaria (CSU), who formed 98% of the sample. Patients were predominantly female (69.6% female, mean age ± SD 39.8 ± 13.29 years). Time since current diagnosis (Mean ± SD) was 28.6 ± 49.06 months. Amongst patients with CSU, 31.0% had comorbid chronic inducible urticaria (CINDU) and 46.4% had a history of angioedema. 91.9% received H1-AH therapy (±other treatments). The most frequently prescribed treatment classes at Baseline were any/combination of medications, not classified under the other 7 treatment classes, named \"Others\" (30.5%) followed by, omalizumab (OMA; 23.6%) and second-generation H1-AH monotherapy (sgAH; 15.1%). At Month 12, the most prescribed treatment classes (>15%) for patients were OMA (23.5%) and \"Other\" (21.3%); 19.7% received \"No drug\". At Month 24, OMA (22.5%), and \"Other\" (17.9%) were most frequently prescribed; 28.6% received \"No drug\". Overall, 79.5% of patients had some type of change in treatment. Over the study period, improvement in self-reported QoL increased, which was mirrored by better disease control.
UNASSIGNED: In AMAC countries, the non-recommended \"Other\" treatment class played a major role in the initial management of CU patients. High usage of H1-AH (±other treatments) and OMA was observed. Treatment changes were observed in a majority of patients. Treatment escalation from sgAH was mostly via OMA. Improvement of disease control and QoL was achieved during the study period.
UNASSIGNED: Observational study (NA).