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

被引：0

作者：

Fukunaga, Atsushi ^{[1
,2
]}

Kakei, Yasumasa ^{[3
,4
]}

Murakami, Sae ^{[4
]}

Kan, Yuji ^{[5
]}

Masuda, Koji ^{[6
]}

Jinnin, Masatoshi ^{[7
]}

Washio, Ken ^{[8
]}

Amano, Hiroo ^{[9
]}

Nagano, Tohru ^{[10
]}

Yamamoto, Akihisa ^{[11
]}

Otsuka, Toshihiro ^{[1
]}

Takahagi, Shunsuke ^{[12
]}

Takenaka, Motoi ^{[13
]}

Ishiguro, Naoko ^{[14
]}

Hayama, Koremasa ^{[15
]}

Inomata, Naoko ^{[16
]}

Nakagawa, Yukinobu ^{[17
]}

Sugiyama, Akiko ^{[18
]}

Hide, Michihiro ^{[12
,19
]}

机构：

[1] Osaka Med & Pharmaceut Univ, Fac Med, Dept Dermatol, Div Med Funct & Morphol Sensory Organs, Takatsuki, Japan

[2] Kobe Univ, Grad Sch Med, Dept Dermatol, Kobe, Japan

[3] Kobe Univ, Grad Sch Med, Dept Oral & Maxillofacial Surg, Kobe, Japan

[4] Kobe Univ Hosp, Clin & Translat Res Ctr, Kobe, Japan

[5] Sapporo Med Univ, Sch Med, Dept Dermatol, Sapporo, Japan

[6] Kyoto Prefectural Univ Med, Grad Sch Med Sci, Dept Dermatol, Kyoto, Japan

[7] Wakayama Med Univ, Dept Dermatol, Wakayama, Japan

[8] Kobe City Nishi Kobe Med Ctr, Dept Dermatol, Kobe, Japan

[9] Iwate Med Univ, Sch Med, Dept Dermatol, Morioka, Japan

[10] Kobe City Med Ctr Gen Hosp, Dept Dermatol, Kobe, Japan

[11] Takarazuka City Hosp, Dept Dermatol, Takarazuka, Japan

[12] Hiroshima Univ, Sch Biomed & Hlth Sci, Dept Dermatol, Hiroshima, Japan

[13] Nagasaki Univ, Sch Biomed Sci, Dept Dermatol, Nagasaki, Japan

[14] Tokyo Womens Med Univ, Dept Dermatol, Shinjuku Ku, Tokyo, Japan

[15] Nihon Univ, Sch Med, Dept Dermatol, Div Cutaneous Sci, Tokyo, Japan

[16] Yokohama City Univ, Sch Med, Dept Environm Immunodermatol, Yokohama, Japan

[17] Osaka Univ, Grad Sch Med, Dept Dermatol, Course Integrated Med, Suita, Japan

[18] Fukuoka Natl Hosp, Natl Hosp Org NHO, Dept Allergol, Fukuoka, Japan

[19] Hiroshima City Hiroshima Citizens Hosp, Dept Dermatol, Hiroshima, Japan

来源：

FRONTIERS IN IMMUNOLOGY | 2024年 / 15卷

关键词：

chronic spontaneous urticaria; histamine H1 antagonists; Japan; sleepiness; quality of life; switching to bilastine; DOUBLE-BLIND; JAPANESE PATIENTS; LEVOCETIRIZINE; ANTIHISTAMINES;

D O I：

10.3389/fimmu.2024.1441478

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background For treating patients with refractory chronic spontaneous urticaria (CSU) resistant to standard doses of 2nd 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.

引用

页数：11

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