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ORIGINAL RESEARCH article
Front. Immunol.
Sec. Autoimmune and Autoinflammatory Disorders: Autoinflammatory Disorders
Volume 15 - 2024 |
doi: 10.3389/fimmu.2024.1441478
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
Provisionally accepted- 1 Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan
- 2 Kobe University Graduate School of Medicine, Kobe, Japan
- 3 Kobe University Hospital, Kobe, Hyōgo, Japan
- 4 Sapporo Medical University School of Medicine, Sapporo, Japan
- 5 Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan
- 6 Wakayama Medical University, Wakayama, Wakayama, Japan
- 7 Kobe City Nishi-Kobe Medical Center, Kobe City, Hyogo, Japan
- 8 School of Medicine, Iwate Medical University, Yahaba, Japan
- 9 Kobe City Medical Center General Hospital, Kobe, Hyōgo, Japan
- 10 Takarazuka City Hospital, Takarazuka, Hyōgo, Japan
- 11 Hiroshima University, Hiroshima, Hiroshima, Japan
- 12 Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Nagasaki, Japan
- 13 Tokyo Women's Medical University, Shinjuku, Tōkyō, Japan
- 14 Nihon University School of Medicine, Tokyo, Japan
- 15 Yokohama City University School of Medicine, Yokohama, Japan
- 16 Osaka University, Suita, Ōsaka, Japan
- 17 Fukuoka Hospital, National Hospital Organization (NHO), Fukuoka, Fukuoka, Japan
Background: For treating patients with refractory chronic spontaneous urticaria (CSU) resistant to standard doses of 2 nd 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 doubledose 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 noninferiority 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.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.
Keywords: chronic urticaria, Histamine H1 Antagonists, Japan, sleepiness, Quality of Life
Received: 03 Jun 2024; Accepted: 26 Aug 2024.
Copyright: © 2024 Fukunaga, Kakei, Murakami, Kan, Masuda, Jinnin, Washio, Amano, Nagano, Yamamoto, Otsuka, Takahagi, Takenaka, Ishiguro, Hayama, Inomata, Nakagawa, Sugiyama and Hide. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Atsushi Fukunaga, Osaka Medical and Pharmaceutical University, Takatsuki, 569-8686, Osaka, Japan
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