Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria
DC Field | Value | Language |
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dc.contributor.author | Michihiro, Hide | - |
dc.contributor.author | Hae-Sim, Park | - |
dc.contributor.author | Atsuyuki, Igarashi | - |
dc.contributor.author | Young-Min, Ye | - |
dc.contributor.author | Tae-Bum, Kim | - |
dc.contributor.author | Akiko, Yagami | - |
dc.contributor.author | Jooyoung, Roh | - |
dc.contributor.author | Jae-Hyun, Lee | - |
dc.contributor.author | Yuko, Chinuki | - |
dc.contributor.author | Woong, Youn Sang | - |
dc.contributor.author | Soo-Keol, Lee | - |
dc.contributor.author | Naoko, Inomata | - |
dc.contributor.author | Jeong-Hee, Choi | - |
dc.contributor.author | Atsushi, Fukunaga | - |
dc.contributor.author | Junyi, Wang | - |
dc.contributor.author | Soichiro, Matsushima | - |
dc.contributor.author | Steve, Greenberg | - |
dc.contributor.author | Sam, Khalil | - |
dc.date.available | 2020-02-27T18:41:15Z | - |
dc.date.created | 2020-02-06 | - |
dc.date.issued | 2017-07 | - |
dc.identifier.issn | 0923-1811 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/5955 | - |
dc.description.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. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER IRELAND LTD | - |
dc.relation.isPartOf | JOURNAL OF DERMATOLOGICAL SCIENCE | - |
dc.subject | QUALITY-OF-LIFE | - |
dc.subject | CHRONIC IDIOPATHIC URTICARIA | - |
dc.subject | SEVERE PERSISTENT ASTHMA | - |
dc.subject | SEVERE ALLERGIC-ASTHMA | - |
dc.subject | ACTIVITY SCORE | - |
dc.subject | DAILY DIARY | - |
dc.subject | POPULATION | - |
dc.subject | GUIDELINE | - |
dc.subject | DIAGNOSIS | - |
dc.subject | THERAPY | - |
dc.title | Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000406893200009 | - |
dc.identifier.doi | 10.1016/j.jdermsci.2017.03.009 | - |
dc.identifier.bibliographicCitation | JOURNAL OF DERMATOLOGICAL SCIENCE, v.87, no.1, pp.70 - 78 | - |
dc.identifier.scopusid | 2-s2.0-85016586241 | - |
dc.citation.endPage | 78 | - |
dc.citation.startPage | 70 | - |
dc.citation.title | JOURNAL OF DERMATOLOGICAL SCIENCE | - |
dc.citation.volume | 87 | - |
dc.citation.number | 1 | - |
dc.contributor.affiliatedAuthor | Jooyoung, Roh | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Antihistamines | - |
dc.subject.keywordAuthor | Chronic spontaneous urticaria | - |
dc.subject.keywordAuthor | Japan | - |
dc.subject.keywordAuthor | Korea | - |
dc.subject.keywordAuthor | Omalizumab | - |
dc.subject.keywordPlus | QUALITY-OF-LIFE | - |
dc.subject.keywordPlus | CHRONIC IDIOPATHIC URTICARIA | - |
dc.subject.keywordPlus | SEVERE PERSISTENT ASTHMA | - |
dc.subject.keywordPlus | SEVERE ALLERGIC-ASTHMA | - |
dc.subject.keywordPlus | ACTIVITY SCORE | - |
dc.subject.keywordPlus | DAILY DIARY | - |
dc.subject.keywordPlus | POPULATION | - |
dc.subject.keywordPlus | GUIDELINE | - |
dc.subject.keywordPlus | DIAGNOSIS | - |
dc.subject.keywordPlus | THERAPY | - |
dc.relation.journalResearchArea | Dermatology | - |
dc.relation.journalWebOfScienceCategory | Dermatology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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