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

Michihiro Hide, Hae Sim Park, Atsuyuki Igarashi, Young Min Ye, Tae Bum Kim, Akiko Yagami, Jooyoung Roh, Jae Hyun Lee, Yuko Chinuki, Sang Woong Youn, Soo Keol Lee, Naoko Inomata, Jeong Hee Choi, Atsushi Fukunaga, Junyi Wang, Soichiro Matsushima, Steve Greenberg, Sam Khalil

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)70-78
Number of pages9
JournalJournal of Dermatological Science
Volume87
Issue number1
DOIs
Publication statusPublished - 07-2017

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Urticaria
Refractory materials
Safety
Placebos
Histamine Antagonists
Therapeutics
Non-Sedating Histamine H1 Antagonists
Nasopharyngitis
Omalizumab
Subcutaneous Injections
Population
Demography
Incidence

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Molecular Biology
  • Dermatology

Cite this

Hide, Michihiro ; Park, Hae Sim ; Igarashi, Atsuyuki ; Ye, Young Min ; Kim, Tae Bum ; Yagami, Akiko ; Roh, Jooyoung ; Lee, Jae Hyun ; Chinuki, Yuko ; Youn, Sang Woong ; Lee, Soo Keol ; Inomata, Naoko ; Choi, Jeong Hee ; Fukunaga, Atsushi ; Wang, Junyi ; Matsushima, Soichiro ; Greenberg, Steve ; Khalil, Sam. / Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria. In: Journal of Dermatological Science. 2017 ; Vol. 87, No. 1. pp. 70-78.
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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.",
author = "Michihiro Hide and Park, {Hae Sim} and Atsuyuki Igarashi and Ye, {Young Min} and Kim, {Tae Bum} and Akiko Yagami and Jooyoung Roh and Lee, {Jae Hyun} and Yuko Chinuki and Youn, {Sang Woong} and Lee, {Soo Keol} and Naoko Inomata and Choi, {Jeong Hee} and Atsushi Fukunaga and Junyi Wang and Soichiro Matsushima and Steve Greenberg and Sam Khalil",
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Hide, M, Park, HS, Igarashi, A, Ye, YM, Kim, TB, Yagami, A, Roh, J, Lee, JH, Chinuki, Y, Youn, SW, Lee, SK, Inomata, N, Choi, JH, Fukunaga, A, Wang, J, Matsushima, S, Greenberg, S & Khalil, S 2017, 'Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria', Journal of Dermatological Science, vol. 87, no. 1, pp. 70-78. https://doi.org/10.1016/j.jdermsci.2017.03.009

Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria. / Hide, Michihiro; Park, Hae Sim; Igarashi, Atsuyuki; Ye, Young Min; Kim, Tae Bum; Yagami, Akiko; Roh, Jooyoung; Lee, Jae Hyun; Chinuki, Yuko; Youn, Sang Woong; Lee, Soo Keol; Inomata, Naoko; Choi, Jeong Hee; Fukunaga, Atsushi; Wang, Junyi; Matsushima, Soichiro; Greenberg, Steve; Khalil, Sam.

In: Journal of Dermatological Science, Vol. 87, No. 1, 07.2017, p. 70-78.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria

AU - Hide, Michihiro

AU - Park, Hae Sim

AU - Igarashi, Atsuyuki

AU - Ye, Young Min

AU - Kim, Tae Bum

AU - Yagami, Akiko

AU - Roh, Jooyoung

AU - Lee, Jae Hyun

AU - Chinuki, Yuko

AU - Youn, Sang Woong

AU - Lee, Soo Keol

AU - Inomata, Naoko

AU - Choi, Jeong Hee

AU - Fukunaga, Atsushi

AU - Wang, Junyi

AU - Matsushima, Soichiro

AU - Greenberg, Steve

AU - Khalil, Sam

PY - 2017/7

Y1 - 2017/7

N2 - 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.

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 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.

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