Gimenez-Arnau A, Bartra J, Ferrer M, Jauregui I, Borbujo J, Figueras I, Muñoz-Bellido F J, Pedraz J, Serra-Baldrich E, Tejedor-Alonso M A, Velasco M, Terradas P, Labrador M
Hospital del Mar, Barcelona, Spain.
Allergy Section, Pulmonology Department, Hospital Clínic, IDIBAPS, ARADyAL, Universitat de Barcelona, Barcelona, Spain.
J Investig Allergol Clin Immunol. 2022 Jun 20;32(3):191-199. doi: 10.18176/jiaci.0661. Epub 2020 Dec 22.
During its first year, the AWARE study assessed disease activity, patient quality of life (QOL), and treatment patterns in chronic urticaria (CU) refractory to H1-antihistamines (H1-AH) in clinical practice.
We performed an observational, prospective (24 months), international, multicenter study. The inclusion criteria were age ≥18 years and H1-AH-refractory CU (>2 months). At each visit, patients completed questionnaires to assess disease burden (Urticaria Control Test [UCT]), disease activity (7 day-Urticaria Activity Score [UAS7]), and QOL (Dermatology Life Quality index [DLQI], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL], and Angioedema Quality of Life Questionnaire [AE-QoL]). We present data for Spain.
The study population comprised 270 evaluable patients (73.3% female, mean [SD] age, 48.9 [14.7] years). At baseline, 89.3% were prescribed a CU treatment. After 1 year, first- and second-line treatments became less frequent and third-line treatments became more frequent. At baseline, 47.0% of patients experienced angioedema; at 1 year, this percentage had fallen to 11.8%. The mean (SD) AE-QoL score decreased from 45.2 (28.7) to 24.0 (25.8). The mean (SD) UCT score decreased from 7.0 (4.5) to 12.1 (4.1). According to UAS7, 38.2% of patients reported absence of wheals and itch in the previous 7 days at 1 year compared with 8.3% at baseline. The mean (SD) DLQI score decreased from 8.0 (7.4) to 2.8 (4.6). At the 1-year visit, the percentage of patients reporting a high or very high impact on QOL fell from 29.9% to 9.6%.
H1-AH-refractory CU in Spain is characterized by absence of control of symptoms and a considerable impact on QOL. Continuous follow-up of CU patients and third-line therapies reduce disease burden and improve patients' QOL.
在第一年，AWARE研究评估了临床实践中对H1抗组胺药（H1-AH）难治的慢性荨麻疹（CU）的疾病活动度、患者生活质量（QOL）和治疗模式。
我们开展了一项观察性、前瞻性（24个月）、国际性、多中心研究。纳入标准为年龄≥18岁且对H1-AH难治的CU（>2个月）。每次就诊时，患者完成问卷以评估疾病负担（荨麻疹控制测试[UCT]）、疾病活动度（7天荨麻疹活动评分[UAS7]）和QOL（皮肤病生活质量指数[DLQI]、慢性荨麻疹生活质量问卷[CU-Q2oL]和血管性水肿生活质量问卷[AE-QoL]）。我们展示西班牙的数据。
研究人群包括270例可评估患者（73.3%为女性，平均[标准差]年龄48.9[14.7]岁）。基线时，89.3%的患者接受了CU治疗。1年后，一线和二线治疗的频率降低，三线治疗的频率增加。基线时，47.0%的患者出现血管性水肿；1年后，这一比例降至11.8%。平均（标准差）AE-QoL评分从45.2（28.7）降至24.0（25.8）。平均（标准差）UCT评分从7.0（4.5）升至12.1（4.1）。根据UAS7，1年后38.2%的患者报告在过去7天内无风团和瘙痒，而基线时为8.3%。平均（标准差）DLQI评分从8.0（7.4）降至2.8（4.6）。在1年随访时，报告对QOL有高或非常高影响的患者比例从29.9%降至9.6%。
西班牙对H1-AH难治的CU的特点是症状控制不佳且对QOL有相当大的影响。对CU患者的持续随访和三线治疗可减轻疾病负担并改善患者的QOL。
