Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria
- Authors
- Michihiro, Hide; Hae-Sim, Park; Atsuyuki, Igarashi; Young-Min, Ye; Tae-Bum, Kim; Akiko, Yagami; Jooyoung, Roh; Jae-Hyun, Lee; Yuko, Chinuki; Woong, Youn Sang; Soo-Keol, Lee; Naoko, Inomata; Jeong-Hee, Choi; Atsushi, Fukunaga; Junyi, Wang; Soichiro, Matsushima; Steve, Greenberg; Sam, Khalil
- Issue Date
- Jul-2017
- Publisher
- ELSEVIER IRELAND LTD
- Keywords
- Antihistamines; Chronic spontaneous urticaria; Japan; Korea; Omalizumab
- Citation
- JOURNAL OF DERMATOLOGICAL SCIENCE, v.87, no.1, pp.70 - 78
- Journal Title
- JOURNAL OF DERMATOLOGICAL SCIENCE
- Volume
- 87
- Number
- 1
- Start Page
- 70
- End Page
- 78
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/5955
- DOI
- 10.1016/j.jdermsci.2017.03.009
- ISSN
- 0923-1811
- Abstract
- Background: Many patients with chronic spontaneous/idiopathic urticaria (CSU/CIU) do not respond adequately to treatment with non-sedating H1 antihistamines (H1AH). There are limited studies on use of omalizumab as add-on therapy for treatment of CSU in an Asian population. Objective: The POLARIS study (NCT02329223), representing the first randomized, double-blind, placebo controlled phase III trial of omalizumab for CSU in an Eastern Asian population, evaluated efficacy and safety of omalizumab as add-on therapy for treatment of CSU. Methods: This 26-week multicenter (41 Japanese/Korean sites) study enrolled patients (12-75 years) who were symptomatic despite H1AH treatment. Eligible participants (N = 218) were randomized 1:1:1 to receive three subcutaneous injections of omalizumab 300 mg, 150 mg, or placebo every 4 weeks, followed by 12 weeks of follow-up. Primary outcome was change from baseline to Week 12 (Wk12) in weekly itch severity score (ISS7). Safety was assessed through the summary of adverse events (AEs). Results: Baseline demographics and disease characteristics were generally well balanced across treatment groups. At Wk12, statistically significant decreases from baseline were observed in ISS7 with omalizumab vs placebo (mean changes -10.22, -8.80, and -6.51 for omalizumab 300 mg, 150 mg and placebo; p < 0.001 and p = 0.006 vs placebo, respectively). Overall AE incidence was similar across treatment groups (54.8%, 57.7%, and 55.4% in omalizumab 300 mg, 150 mg, and placebo groups, respectively); nasopharyngitis was the most frequently reported AE in all treatment arms. Conclusion: The POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU. (C) 2017 The Authors. Published by Elsevier Ireland Ltd on behalf of Japanese Society for Investigative Dermatology.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - 의과대학 > 의학과 > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/5955)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.