在难治性慢性自发性荨麻疹（H1-SWITCH）患者中转换为 H1 抗组胺药比拉斯汀的疗效和安全性：一项多中心、开放标签、随机、平行组比较研究。
Efficacy and safety of switching to bilastine, an H1-antihistamine, in patients with refractory chronic spontaneous urticaria (H1-SWITCH): a multicenter, open-label, randomized, parallel-group comparative study.
机构信息
Department of Dermatology, Division of Medicine for Function and Morphology of Sensory Organs, Faculty of Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Department of Dermatology, Kobe University Graduate School of Medicine, Kobe, Japan.
出版信息
Front Immunol. 2024 Sep 16;15:1441478. doi: 10.3389/fimmu.2024.1441478. eCollection 2024.
BACKGROUND
For treating patients with refractory chronic spontaneous urticaria (CSU) resistant to standard doses of 2 generation H1-antihistamines (H1AH) the International and Japanese guidelines recommend increasing H1AH dose. The latter also recommends switching to a different H1AH. This study explored if the efficacy of the standard dose of bilastine 20 mg is non-inferior to that of double-dose of H1AH in patients with refractory CSU.
METHODS
This phase IV, multicenter, open-label, randomized, parallel-group trial evaluated the efficacy and safety of switching treatment to bilastine compared to treatment with a 2-fold dose of H1AH in patients with CSU refractory to standard dose H1AH. The primary endpoint was the mean total symptom score (TSS) at Day 5-7 after the start of administration.
RESULTS
Treatment efficacy and safety were evaluated in 128 patients (bilastine, n=64; 2-fold dose of H1AH, n=64). The mean TSS at Day 5-7 after the start of administration was smaller than the non-inferiority margin of 0.8, demonstrating non-inferiority of the bilastine switching group to the double-dose H1AH group (0.17 (95% CI -0.32, 0.67)). No difference in Japanese version of Epworth Sleepiness Scale (JESS), DLQI, and urticaria activity score over 7 consecutive days (UAS7) was observed between the two groups. There were no serious adverse events in either group. H1AH-related adverse events occurred in 5 subjects (8 cases) and 2 subjects (3 cases) in the double-dose H1AH and bilastine groups, respectively.
CONCLUSIONS
Switching treatment to bilastine demonstrated non-inferiority to a double-dose of H1AH in terms of efficacy in patients with CSU refractory to standard dose H1AH with a favorable safety profile.
CLINICAL TRIAL REGISTRATION
https://jrct.niph.go.jp/latest-detail/jRCTs051180105, identifier jRCTs051180105.
背景
对于标准剂量第二代 H1 抗组胺药（H1AH）治疗抵抗的难治性慢性自发性荨麻疹（CSU）患者，国际和日本指南建议增加 H1AH 剂量。后者还建议改用不同的 H1AH。本研究探讨了标准剂量比拉斯汀 20mg 的疗效是否不劣于难治性 CSU 患者的 H1AH 双倍剂量。
方法
这是一项四期、多中心、开放标签、随机、平行组试验，评估了与 H1AH 双倍剂量相比，转换为比拉斯汀治疗对标准剂量 H1AH 治疗抵抗的 CSU 患者的疗效和安全性。主要终点是治疗开始后第 5-7 天的平均总症状评分（TSS）。
结果
在 128 名患者（比拉斯汀组 n=64；H1AH 双倍剂量组 n=64）中评估了治疗效果和安全性。治疗开始后第 5-7 天的平均 TSS 小于 0.8 的非劣效性边界，表明比拉斯汀转换组与 H1AH 双倍剂量组等效（0.17（95%CI-0.32，0.67））。两组之间日本版 Epworth 嗜睡量表（JESS）、DLQI 和 7 天连续 UAS7 无差异。两组均未发生严重不良事件。H1AH 相关不良事件在 H1AH 双倍剂量组和比拉斯汀组分别发生 5 例（8 例）和 2 例（3 例）。
结论
对于标准剂量 H1AH 治疗抵抗的 CSU 患者，转换为比拉斯汀治疗在疗效方面不劣于 H1AH 双倍剂量，且安全性良好。
临床试验注册
https://jrct.niph.go.jp/latest-detail/jRCTs051180105，标识符 jRCTs051180105。
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