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Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria

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dc.contributor.authorHide, M-
dc.contributor.authorPark, HS-
dc.contributor.authorIgarashi, A-
dc.contributor.authorYe, YM-
dc.contributor.authorKim, TB-
dc.contributor.authorYagami, A-
dc.contributor.authorRoh, J-
dc.contributor.authorLee, JH-
dc.contributor.authorChinuki, Y-
dc.contributor.authorYoun, SW-
dc.contributor.authorLee, SK-
dc.contributor.authorInomata, N-
dc.contributor.authorChoi, JH-
dc.contributor.authorFukunaga, A-
dc.contributor.authorWang, J-
dc.contributor.authorMatsushima, S-
dc.contributor.authorGreenberg, S-
dc.contributor.authorKhalil, S-
dc.date.accessioned2018-08-24T01:48:45Z-
dc.date.available2018-08-24T01:48:45Z-
dc.date.issued2017-
dc.identifier.issn0923-1811-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/15892-
dc.description.abstractBACKGROUND: 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.
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dc.language.isoen-
dc.subject.MESHAdult-
dc.subject.MESHChronic Disease-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHOmalizumab-
dc.subject.MESHUrticaria-
dc.titleEfficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria-
dc.typeArticle-
dc.identifier.pmid28366435-
dc.contributor.affiliatedAuthor박, 해심-
dc.contributor.affiliatedAuthor예, 영민-
dc.type.localJournal Papers-
dc.identifier.doi10.1016/j.jdermsci.2017.03.009-
dc.citation.titleJournal of dermatological science-
dc.citation.volume87-
dc.citation.number1-
dc.citation.date2017-
dc.citation.startPage70-
dc.citation.endPage78-
dc.identifier.bibliographicCitationJournal of dermatological science, 87(1). : 70-78, 2017-
dc.embargo.liftdate9999-12-31-
dc.embargo.terms9999-12-31-
dc.identifier.eissn1873-569X-
dc.relation.journalidJ009231811-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Allergy
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