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

https://doi.org/10.1016/j.jdermsci.2017.03.009Get rights and content
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Highlights

  • The first phase III trial of omalizumab for CSU in an East Asian population was performed.

  • Omalizumab was efficacious in H1 antihistamine-refractory patients with CSU.

  • Omalizumab was well tolerated in Japanese and Korean CSU patients.

  • Findings were consistent with results of previous global studies of omalizumab.

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 300 mg, 150 mg, 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 300 mg, 150 mg 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 300 mg, 150 mg, 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.

Abbreviations

AE
adverse event
ANCOVA
analysis of covariance
BMI
body mass index
BOCF
baseline-observation-carried-forward
CIU
chronic idiopathic urticaria
CSU
chronic spontaneous urticaria
DLQI
Dermatology Life Quality Index
EAACI
European Academy of Allergy & Clinical Immunology
EDF
European Dermatology Forum
FAS
full analysis set
GA2LEN
Global Allergy and Asthma European Network
H1AH
H1 antihistamine
IRT
interactive response technology
JDA
Japanese Dermatological Association
LOCF
last-observation-carried-forward
LS
least-squares
LTRA
leukotriene receptor antagonist
MID
minimally important difference
MMRM
mixed model with repeated measures
PPS
per-protocol set
QoL
quality of life
SAE
serious adverse event
SAF
safety set
SE
standard error
UAS
urticaria activity score
WAO
World Allergy Organization

Keywords

Antihistamines
Chronic spontaneous urticaria
Japan
Korea
Omalizumab

Cited by (0)

1

These two authors contributed equally to this work.

2

Present address: 419 Everson Place, Westfield, NJ 07090, USA.