PMID- 29102514
OWN - NLM
STAT- MEDLINE
DCOM- 20180917
LR  - 20221207
IS  - 1440-1592 (Electronic)
IS  - 1323-8930 (Linking)
VI  - 67
IP  - 2
DP  - 2018 Apr
TI  - Efficacy and safety of omalizumab for the treatment of refractory chronic 
      spontaneous urticaria in Japanese patients: Subgroup analysis of the phase 3 
      POLARIS study.
PG  - 243-252
LID - S1323-8930(17)30154-5 [pii]
LID - 10.1016/j.alit.2017.10.001 [doi]
AB  - BACKGROUND: Omalizumab, a humanized anti-IgE monoclonal antibody, proved 
      efficacious and well tolerated in patients with chronic spontaneous urticaria 
      (CSU) refractory to H(1) antihistamines (H(1)AH) in the POLARIS study 
      (NCT02329223), a randomized, double-blind, placebo-controlled trial in East Asian 
      patients. However, data in Japanese patients, who have specific baseline 
      characteristics (e.g., low angioedema incidence, different background 
      medications) that may impact clinical outcomes, are lacking. This pre-specified 
      analysis presents additional patient-level data over time, pharmacokinetic and 
      pharmacodynamics data for omalizumab and IgE, and efficacy and safety data for 
      omalizumab in Japanese patients. METHODS: Japanese patients (N = 105) were 
      randomized 1:1:1 to omalizumab 300 mg, 150 mg, or placebo by subcutaneous 
      injection every 4 weeks. Efficacy and safety were assessed primarily based on 
      changes from baseline to Week 12 in weekly itch-severity scores (ISS7) and weekly 
      urticaria activity scores (UAS7), and incidence of adverse events (AEs), 
      respectively. Patient-level UAS7 data over time were also reviewed. RESULTS: At 
      Week 12, least squares mean (LSM) changes from baseline in ISS7 were greater with 
      omalizumab vs. placebo (-9.54 and -7.29 for omalizumab 300 mg and 150 mg, 
      respectively, vs. placebo [-5.17]). Corresponding LSM changes from baseline in 
      UAS7 were -21.61 and -15.59 (vs. placebo [-10.88]). Most responders in the 
      omalizumab 300 mg group displayed improvement of disease activity within 2-4 
      weeks and had well-controlled symptoms during the treatment period. Overall AE 
      incidence was similar across treatment arms. CONCLUSIONS: This subgroup analysis 
      demonstrated that omalizumab is a well-tolerated, beneficial option for treatment 
      of CSU in H(1)AH-refractory Japanese patients.
CI  - Copyright (c) 2018 Japanese Society of Allergology. Production and hosting 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 - Igarashi, Atsuyuki
AU  - Igarashi A
AD  - Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
FAU - Yagami, Akiko
AU  - Yagami A
AD  - Department of Dermatology, Fujita Health University School of Medicine, Toyoake, 
      Japan.
FAU - Chinuki, Yuko
AU  - Chinuki Y
AD  - Department of Dermatology, Shimane University Faculty of Medicine, Shimane, 
      Japan.
FAU - Inomata, Naoko
AU  - Inomata N
AD  - Department of Environmental Immuno-Dermatology, Yokohama City University Graduate 
      School of Medicine, Yokohama, Japan.
FAU - Fukunaga, Atsushi
AU  - Fukunaga A
AD  - Division of Dermatology, Department of Internal Related, Kobe University Graduate 
      School of Medicine, Kobe, Japan.
FAU - Kaiser, Guenther
AU  - Kaiser G
AD  - Novartis Pharma AG, Basel, Switzerland.
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, Steven
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  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20171101
PL  - England
TA  - Allergol Int
JT  - Allergology international : official journal of the Japanese Society of 
      Allergology
JID - 9616296
RN  - 0 (Anti-Allergic Agents)
RN  - 2P471X1Z11 (Omalizumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Allergic Agents/*therapeutic use
MH  - Asian People
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Omalizumab/*therapeutic use
MH  - Treatment Outcome
MH  - Urticaria/*drug therapy
MH  - Young Adult
OTO - NOTNLM
OT  - Antihistamines
OT  - Chronic spontaneous urticaria
OT  - IgE
OT  - Japan
OT  - Omalizumab
EDAT- 2017/11/06 06:00
MHDA- 2018/09/18 06:00
CRDT- 2017/11/06 06:00
PHST- 2017/08/24 00:00 [received]
PHST- 2017/09/12 00:00 [revised]
PHST- 2017/09/20 00:00 [accepted]
PHST- 2017/11/06 06:00 [pubmed]
PHST- 2018/09/18 06:00 [medline]
PHST- 2017/11/06 06:00 [entrez]
AID - S1323-8930(17)30154-5 [pii]
AID - 10.1016/j.alit.2017.10.001 [doi]
PST - ppublish
SO  - Allergol Int. 2018 Apr;67(2):243-252. doi: 10.1016/j.alit.2017.10.001. Epub 2017 
      Nov 1.