title: Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria.
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.
  
  
  CONCLUSIONS
  The POLARIS study demonstrates that omalizumab is an efficacious and well-tolerated add-on therapy in Japanese and Korean H1AH-refractory patients with CSU.
authors.affiliation: Department of Dermatology, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Michihiro
authors.initials: M
authors.lastname: Hide
authors.affiliation: Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Hae-Sim
authors.initials: HS
authors.lastname: Park
authors.affiliation: Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: Igarashi
authors.affiliation: Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Young-Min
authors.initials: YM
authors.lastname: Ye
authors.affiliation: Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Tae-Bum
authors.initials: TB
authors.lastname: Kim
authors.affiliation: Department of Dermatology, Fujita Health University School of Medicine, Toyoake, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Yagami
authors.affiliation: Department of Dermatology, Gachon University Gil Medical Center, Incheon, Korea.
authors.forename: Jooyoung
authors.initials: J
authors.lastname: Roh
authors.affiliation: Department of Internal Medicine, Institute of Allergy, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jae-Hyun
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Dermatology, Shimane University Faculty of Medicine, Shimane, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Chinuki
authors.affiliation: Department of Dermatology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Sang Woong
authors.initials: SW
authors.lastname: Youn
authors.affiliation: Department of Internal Medicine, Dong-A University School of Medicine, Busan, Korea.
authors.forename: Soo-Keol
authors.initials: SK
authors.lastname: Lee
authors.affiliation: Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
authors.forename: Naoko
authors.initials: N
authors.lastname: Inomata
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.
authors.forename: Jeong-Hee
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Fukunaga
authors.affiliation: Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Junyi
authors.initials: J
authors.lastname: Wang
authors.affiliation: Novartis Pharma K.K., Tokyo, Japan.
authors.forename: Soichiro
authors.initials: S
authors.lastname: Matsushima
authors.affiliation: Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Greenberg
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. Electronic address: sam.khalil@novartis.com.
authors.forename: Sam
authors.initials: S
authors.lastname: Khalil
mesh_terms: D000328:Adult; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000009:adverse effects / Q000627:therapeutic use*; D014581:Urticaria / Q000188:drug therapy*
chemical_list: D000069444:Omalizumab
keywords: Antihistamines; Chronic spontaneous urticaria; Japan; Korea; Omalizumab