Cited 49 times in
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 | 이재현 | - |
dc.date.accessioned | 2023-08-09T02:41:54Z | - |
dc.date.available | 2023-08-09T02:41:54Z | - |
dc.date.issued | 2017-07 | - |
dc.identifier.issn | 0923-1811 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/195759 | - |
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 300mg, 150mg, 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 300mg, 150mg 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 300mg, 150mg, 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF DERMATOLOGICAL SCIENCE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Chronic Disease | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Omalizumab / adverse effects | - |
dc.subject.MESH | Omalizumab / therapeutic use* | - |
dc.subject.MESH | Urticaria / drug therapy* | - |
dc.title | Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Michihiro Hide | - |
dc.contributor.googleauthor | Hae-Sim Park | - |
dc.contributor.googleauthor | Atsuyuki Igarashi | - |
dc.contributor.googleauthor | Young-Min Ye | - |
dc.contributor.googleauthor | Tae-Bum Kim | - |
dc.contributor.googleauthor | Akiko Yagami | - |
dc.contributor.googleauthor | Jooyoung Roh | - |
dc.contributor.googleauthor | Jae-Hyun Lee | - |
dc.contributor.googleauthor | Yuko Chinuki | - |
dc.contributor.googleauthor | Sang Woong Youn | - |
dc.contributor.googleauthor | Soo-Keol Lee | - |
dc.contributor.googleauthor | Naoko Inomata | - |
dc.contributor.googleauthor | Jeong-Hee Choi | - |
dc.contributor.googleauthor | Atsushi Fukunaga | - |
dc.contributor.googleauthor | Junyi Wang | - |
dc.contributor.googleauthor | Soichiro Matsushima | - |
dc.contributor.googleauthor | Steve Greenberg | - |
dc.contributor.googleauthor | Sam Khalil | - |
dc.identifier.doi | 10.1016/j.jdermsci.2017.03.009 | - |
dc.contributor.localId | A03086 | - |
dc.relation.journalcode | J01370 | - |
dc.identifier.eissn | 1873-569X | - |
dc.identifier.pmid | 28366435 | - |
dc.subject.keyword | Antihistamines | - |
dc.subject.keyword | Chronic spontaneous urticaria | - |
dc.subject.keyword | Japan | - |
dc.subject.keyword | Korea | - |
dc.subject.keyword | Omalizumab | - |
dc.contributor.alternativeName | Lee, Jae Hyun | - |
dc.contributor.affiliatedAuthor | 이재현 | - |
dc.citation.volume | 87 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 70 | - |
dc.citation.endPage | 78 | - |
dc.identifier.bibliographicCitation | JOURNAL OF DERMATOLOGICAL SCIENCE, Vol.87(1) : 70-78, 2017-07 | - |
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