Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients: Subgroup analysis of the phase 3 POLARIS study.

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Abstract

Omalizumab, a humanized anti-IgE monoclonal antibody, proved efficacious and well tolerated in patients with chronic spontaneous urticaria (CSU) refractory to H1 antihistamines (H1AH) 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.

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Author and article information

Journal

Journal ID (iso-abbrev): Allergol Int

Title: Allergology international : official journal of the Japanese Society of Allergology

Publisher: Elsevier BV

ISSN (Electronic): 1440-1592

ISSN (Print): 1323-8930

Publication date (Electronic): Apr 2018

Volume: 67

Issue: 2

Affiliations

[1 ] Department of Dermatology, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.

[2 ] Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.

[3 ] Department of Dermatology, Fujita Health University School of Medicine, Toyoake, Japan.

[4 ] Department of Dermatology, Shimane University Faculty of Medicine, Shimane, Japan.

[5 ] Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

[6 ] Division of Dermatology, Department of Internal Related, Kobe University Graduate School of Medicine, Kobe, Japan.

[7 ] Novartis Pharma AG, Basel, Switzerland.

[8 ] Novartis Pharma K.K., Tokyo, Japan.

[9 ] Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.

[10 ] Novartis Pharma AG, Basel, Switzerland. Electronic address: sam.khalil@novartis.com.

Article

Publisher Item ID: S1323-8930(17)30154-5

DOI: 10.1016/j.alit.2017.10.001

PubMed ID: 29102514

SO-VID: bc3d4919-a334-4fcf-b725-b60edc9ac085

History

Keywords: Chronic spontaneous urticaria,Omalizumab,Japan,Antihistamines,IgE

Data availability:

Keywords: Chronic spontaneous urticaria, Omalizumab, Japan, Antihistamines, IgE

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