抗组胺药耐药性慢性自发性荨麻疹仍治疗不足：来自 AWARE 研究的 2 年数据。

Antihistamine-resistant chronic spontaneous urticaria remains undertreated: 2-year data from the AWARE study.

机构信息

Dermatological Allergology, Department of Dermatology, Venereology, and Allergology, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany.

Serviço de Imunoalergologia, Hospital de Santa Maria, Lisbon, Portugal.

出版信息

Clin Exp Allergy. 2020 Oct;50(10):1166-1175. doi: 10.1111/cea.13716. Epub 2020 Sep 3.

DOI:10.1111/cea.13716

PMID:32735720

Abstract

BACKGROUND

Real-world evidence describing the benefits of recommended therapies and their impact on the quality of life (QoL) of chronic urticaria (CU) patients is limited.

OBJECTIVE

To investigate disease burden, current treatment schedule, and the use of clinical resources by patients with H -antihistamine-refractory CU in Europe.

METHODS

AWARE (A World-wide Antihistamine-Refractory chronic urticaria patient Evaluation) is a global, prospective, non-interventional study in the real-world setting, sponsored by the manufacturer of omalizumab. Disease characteristics, pharmacological treatments, and health-related QoL of patients (N = 2727) ≥18 years of age diagnosed with H -antihistamine-refractory chronic spontaneous urticaria (without inducible urticaria) for >2 months are reported here.

RESULTS

Of the 2727 patients included, 1232 (45.2%) and 1278 (46.9%) were successfully followed up for any assessment and for the key outcome, the urticaria control test (UCT) score, respectively, and patients with complete remission (14.1%) were excluded from analyses.The proportion of patients with uncontrolled CSU (UCT score <12) dropped from 78% (n/N = 1641/2104) at baseline to 28.7% (n/N = 269/936) after two years of participation in the AWARE study. In addition, the proportion of patients with no impact of CSU on their QoL (assessed by the Dermatological Life Quality Index) increased to 57% (n/N = 664/1164) from 18.7% (n/N = 491/2621) at baseline. Emergency room visits (2.4% [n/N = 7/296] vs 33.5% [n/N = 779/2322]) and hospital stays (1.7% [n/N = 5/296] vs 24.2% [n/N = 561/2322]) reduced at Month 24 vs baseline. Overall, 23.2% (n/N = 26/112) patients on non-sedating H -antihistamines (nsAH) and 41.9% (n/N = 44/105) patients on up-dosed nsAH had uncontrolled CSU (UCT <12) at Month 24. In omalizumab-treated patients, 27.1% (n/N = 78/288) had uncontrolled CSU at Month 24.

CONCLUSION

These data confirm improvements for most patients with CSU over a 2-year follow-up period. Further studies are needed to understand the differences between guideline recommendations and reported management.

摘要

背景

描述推荐疗法的益处及其对慢性荨麻疹（CU）患者生活质量（QoL）影响的真实世界证据有限。

目的

调查在欧洲，H 抗组胺药难治性 CU 患者的疾病负担、当前治疗方案和临床资源的使用情况。

方法

AWARE（一种全球、前瞻性、非干预性研究，由奥马珠单抗制造商赞助）是一项在真实世界环境中进行的研究，纳入了≥18 岁、诊断为 H 抗组胺药难治性慢性自发性荨麻疹（无诱导性荨麻疹）>2 个月的患者。报告了这里报告了患者的疾病特征、药物治疗和健康相关 QoL。

结果

在 2727 名患者中，1232 名（45.2%）和 1278 名（46.9%）患者分别成功进行了任何评估和关键结局（荨麻疹控制测试 [UCT] 评分）的随访，且有 14.1%的完全缓解患者被排除在分析之外。基线时，78%（n/N=1641/2104）的患者存在未控制的 CSU（UCT 评分<12），两年后参加 AWARE 研究后，这一比例降至 28.7%（n/N=269/936）。此外，无 CU 对其 QoL 影响（通过皮肤病生活质量指数评估）的患者比例从基线时的 18.7%（n/N=491/2621）增加到 57%（n/N=664/1164）。与基线相比，急诊就诊（2.4%[n/N=7/296] vs. 33.5%[n/N=779/2322]）和住院治疗（1.7%[n/N=5/296] vs. 24.2%[n/N=561/2322]）在第 24 个月减少。总体而言，在非镇静性 H 抗组胺药（nsAH）治疗的 23.2%（n/N=26/112）患者和剂量增加的 nsAH 治疗的 41.9%（n/N=44/105）患者中，第 24 个月仍存在未控制的 CSU（UCT<12）。在奥马珠单抗治疗的患者中，27.1%（n/N=78/288）在第 24 个月仍存在未控制的 CSU。