Background

Chronic spontaneous urticaria (CSU) not controlled by optimized doses of antihistamines is referred to as refractory CSU. Add-on therapies recommended by guidelines include omalizumab, immunosuppressive, and anti-inflammatory agents.

Objectives

The objective of the study was to assess the real-world effectiveness of different add-on treatment options for refractory CSU in 2 large clinical practices.

Methods

A retrospective chart review was conducted in 264 patients with refractory CSU not adequately controlled for ≥6 weeks with optimized doses of second-generation histamine-1 blockers. Omalizumab and hydroxychloroquine were the most frequently prescribed add-on therapies, allowing comparisons of clinical outcomes for these 2 agents. Complete response included absent or infrequent urticaria and patient satisfaction with treatment. Partial response was reduced hives, but requiring a second add-on therapy. Sustained response was complete response to an add-on therapy for ≥1 year.

Results

Omalizumab add-on treatment was significantly more likely to be associated with a complete response versus hydroxychloroquine. Complete sustained response at 1 year was observed in 82% (111 of 134) of patients on omalizumab and 66% (73 of 111) on hydroxychloroquine as the first add-on therapy (P < .01). Patients with thyroid disease had a poorer response to add-on treatments (45% responded vs 63%; P = .03). In patients with incomplete responses to first add-on interventions (n = 45), 65% and 62% subsequently had complete responses to omalizumab and hydroxychloroquine, respectively.

Conclusions

Although omalizumab was superior, hydroxychloroquine achieved a complete response in two-thirds of treated patients. Given a favorable safety profile, hydroxychloroquine should be considered as an add-on treatment for refractory CSU.

中文翻译：

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羟氯喹和奥马珠单抗治疗慢性自发性荨麻疹的有效性：一项真实世界研究

背景

无法通过最佳剂量的抗组胺药控制的慢性自发性荨麻疹(CSU)被称为难治性 CSU。指南推荐的附加疗法包括奥马珠单抗、免疫抑制剂和抗炎药。

目标

该研究的目的是评估 2 个大型临床实践中针对难治性 CSU 的不同附加治疗方案的实际有效性。

方法

对 264 名难治性 CSU 患者进行了回顾性图表审查，使用优化剂量的第二代组胺-1 阻滞剂未充分控制 ≥6 周。奥马珠单抗和羟氯喹是最常用的附加疗法，可以对这两种药物的临床结果进行比较。完全缓解包括荨麻疹消失或罕见以及患者对治疗的满意度。部分缓解是荨麻疹减少，但需要第二次附加治疗。持续缓解是对附加治疗≥1年的完全缓解。

结果

与羟氯喹相比，奥马珠单抗附加治疗更有可能获得完全缓解。在接受奥马珠单抗治疗的患者中，82%（134 名患者中的 111 名）在 1 年时观察到了完全持续缓解，而在使用羟氯喹作为第一种附加治疗的患者中，有 66%（111 名患者中的 73 名）出现了完全持续缓解 ( P < .01)。甲状腺疾病患者对附加治疗的反应较差（45% 有反应 vs 63%；P  = .03）。在对首次附加干预措施反应不完全的患者中 (n = 45)，随后分别有 65% 和 62% 对奥马珠单抗和羟氯喹产生完全反应。

结论

尽管奥马珠单抗效果更好，但羟氯喹在三分之二的治疗患者中实现了完全缓解。鉴于良好的安全性，羟氯喹应被视为难治性 CSU 的附加治疗。