PMID- 28366435
OWN - NLM
STAT- MEDLINE
DCOM- 20180406
LR  - 20220408
IS  - 1873-569X (Electronic)
IS  - 0923-1811 (Linking)
VI  - 87
IP  - 1
DP  - 2017 Jul
TI  - Efficacy and safety of omalizumab in Japanese and Korean patients with refractory 
      chronic spontaneous urticaria.
PG  - 70-78
LID - S0923-1811(17)30087-7 [pii]
LID - 10.1016/j.jdermsci.2017.03.009 [doi]
AB  - 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.
CI  - Copyright (c) 2017 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Hide, Michihiro
AU  - Hide M
AD  - Department of Dermatology, Institute of Biomedical and Health Sciences, Hiroshima 
      University, Hiroshima, Japan.
FAU - Park, Hae-Sim
AU  - Park HS
AD  - Department of Allergy and Clinical Immunology, Ajou University School of 
      Medicine, Suwon, Korea.
FAU - Igarashi, Atsuyuki
AU  - Igarashi A
AD  - Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
FAU - Ye, Young-Min
AU  - Ye YM
AD  - Department of Allergy and Clinical Immunology, Ajou University School of 
      Medicine, Suwon, Korea.
FAU - Kim, Tae-Bum
AU  - Kim TB
AD  - Department of Allergy and Clinical Immunology, Asan Medical Center, University of 
      Ulsan College of Medicine, Seoul, Korea.
FAU - Yagami, Akiko
AU  - Yagami A
AD  - Department of Dermatology, Fujita Health University School of Medicine, Toyoake, 
      Japan.
FAU - Roh, Jooyoung
AU  - Roh J
AD  - Department of Dermatology, Gachon University Gil Medical Center, Incheon, Korea.
FAU - Lee, Jae-Hyun
AU  - Lee JH
AD  - Department of Internal Medicine, Institute of Allergy, Yonsei University College 
      of Medicine, Seoul, Korea.
FAU - Chinuki, Yuko
AU  - Chinuki Y
AD  - Department of Dermatology, Shimane University Faculty of Medicine, Shimane, 
      Japan.
FAU - Youn, Sang Woong
AU  - Youn SW
AD  - Department of Dermatology, Seoul National University Bundang Hospital, Seoul 
      National University College of Medicine, Seoul, Korea.
FAU - Lee, Soo-Keol
AU  - Lee SK
AD  - Department of Internal Medicine, Dong-A University School of Medicine, Busan, 
      Korea.
FAU - Inomata, Naoko
AU  - Inomata N
AD  - Department of Environmental Immuno-Dermatology, Yokohama City University Graduate 
      School of Medicine, Yokohama, Japan.
FAU - Choi, Jeong-Hee
AU  - Choi JH
AD  - Department of Internal Medicine, Hallym University College of Medicine, 
      Chuncheon, Korea.
FAU - Fukunaga, Atsushi
AU  - Fukunaga A
AD  - Division of Dermatology, Department of Internal Related, Kobe University Graduate 
      School of Medicine, Kobe, Japan.
FAU - Wang, Junyi
AU  - Wang J
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Matsushima, Soichiro
AU  - Matsushima S
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Greenberg, Steve
AU  - Greenberg S
AD  - Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.
FAU - Khalil, Sam
AU  - Khalil S
AD  - Novartis Pharma AG, Basel, Switzerland. Electronic address: 
      sam.khalil@novartis.com.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170321
PL  - Netherlands
TA  - J Dermatol Sci
JT  - Journal of dermatological science
JID - 9011485
RN  - 2P471X1Z11 (Omalizumab)
SB  - IM
MH  - Adult
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Omalizumab/adverse effects/*therapeutic use
MH  - Urticaria/*drug therapy
OTO - NOTNLM
OT  - Antihistamines
OT  - Chronic spontaneous urticaria
OT  - Japan
OT  - Korea
OT  - Omalizumab
EDAT- 2017/04/04 06:00
MHDA- 2018/04/07 06:00
CRDT- 2017/04/04 06:00
PHST- 2017/03/02 00:00 [received]
PHST- 2017/03/14 00:00 [accepted]
PHST- 2017/04/04 06:00 [pubmed]
PHST- 2018/04/07 06:00 [medline]
PHST- 2017/04/04 06:00 [entrez]
AID - S0923-1811(17)30087-7 [pii]
AID - 10.1016/j.jdermsci.2017.03.009 [doi]
PST - ppublish
SO  - J Dermatol Sci. 2017 Jul;87(1):70-78. doi: 10.1016/j.jdermsci.2017.03.009. Epub 
      2017 Mar 21.