Kim Mi-Ae, Choi Jeong-Hee, Shin Yoo-Seob, Park Hae-Sim, Ye Young-Min
Department of Pulmonology, Allergy and Critical Care Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.
Allergy Asthma Immunol Res. 2023 Jul;15(4):496-511. doi: 10.4168/aair.2023.15.4.496. Epub 2023 Mar 7.
The prevalence of chronic urticaria (CU) is increasing worldwide, and it imposes a major burden on patients. Few studies have evaluated the efficacy of second-line treatments of CU, particularly for patients being considered for costly third-line treatments such as omalizumab. We compared the efficacy and safety of second-line treatments of CU refractory to standard doses of nonsedating H-antihistamines (nsAHs).
This 4-week, prospective, randomized, open-label trial divided patients into 4 treatment groups: 4-fold updosing of nsAHs, multiple combination of 4 nsAHs, switching to other nsAHs, and adjunctive H-receptor antagonist. The clinical outcomes included urticaria control status, symptoms, and rescue medication use.
This study included 109 patients. After 4 weeks of second-line treatment, urticaria was well-controlled, partly controlled, and uncontrolled in 43.1%, 36.7%, and 20.2% of patients, respectively. Complete control of CU was achieved in 20.4% of patients. Among the patients with high-dose nsAHs, the proportion with well-controlled status was higher compared to the patients who received standard doses (51.9% vs. 34.5%, = 0.031). No significant difference was observed in the proportion of well-controlled cases between the updosing and combination treatment groups (57.7% vs. 46.4%, = 0.616). However, increasing the dose of nsAHs 4-fold was associated with a higher rate of complete symptom control compared to multiple combination treatment with 4 nsAHs (40.0% vs. 10.7%, = 0.030). Logistic regression analysis confirmed the higher efficacy of updosing of nsAHs for complete control of CU compared to the other treatment strategies (odds ratio, 0.180; = 0.020).
In patients with CU refractory to standard doses of nsAHs, both updosing of nsAHs 4-fold and multiple combination treatment with 4 nsAHs increased the rate of well-controlled cases without causing significant adverse effects. Updosing of nsAHs is more effective for complete CU control than combination treatment.
慢性荨麻疹(CU)在全球的患病率正在上升,给患者带来了沉重负担。很少有研究评估CU二线治疗的疗效,特别是对于考虑使用奥马珠单抗等昂贵三线治疗的患者。我们比较了对标准剂量非镇静性H-抗组胺药(nsAHs)难治的CU二线治疗的疗效和安全性。
这项为期4周的前瞻性、随机、开放标签试验将患者分为4个治疗组:nsAHs剂量增加4倍、4种nsAHs联合使用、换用其他nsAHs以及加用H受体拮抗剂。临床结局包括荨麻疹控制状态、症状和急救药物使用情况。
本研究纳入了109例患者。二线治疗4周后,荨麻疹得到良好控制、部分控制和未控制的患者分别占43.1%、36.7%和20.2%。20.4%的患者实现了CU的完全控制。在高剂量nsAHs治疗的患者中,病情得到良好控制的比例高于接受标准剂量治疗的患者(51.9%对34.5%,P = 0.031)。剂量增加组和联合治疗组病情得到良好控制的病例比例无显著差异(57.7%对46.4%,P = 0.616)。然而,与4种nsAHs联合治疗相比,nsAHs剂量增加4倍与完全症状控制率更高相关(40.0%对10.7%,P = 0.030)。逻辑回归分析证实,与其他治疗策略相比,nsAHs剂量增加对CU完全控制的疗效更高(优势比,0.180;P = 0.020)。
在对标准剂量nsAHs难治的CU患者中,nsAHs剂量增加4倍和4种nsAHs联合治疗均提高了病情得到良好控制的病例比例,且未引起显著不良反应。nsAHs剂量增加对CU完全控制比联合治疗更有效。