Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients

Subgroup analysis of the phase 3 POLARIS study

Michihiro Hide, Atsuyuki Igarashi, Akiko Yagami, Yuko Chinuki, Naoko Inomata, Atsushi Fukunaga, Guenther Kaiser, Junyi Wang, Soichiro Matsushima, Steven Greenberg, Sam Khalil

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: 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. 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 H1AH-refractory Japanese patients.

Original languageEnglish
Pages (from-to)243-252
Number of pages10
JournalAllergology International
Volume67
Issue number2
DOIs
Publication statusPublished - 01-04-2018

Fingerprint

Urticaria
Safety
Placebos
Histamine Antagonists
Therapeutics
Least-Squares Analysis
Incidence
Angioedema
Omalizumab
Subcutaneous Injections
Immunoglobulin E
Pharmacokinetics
Monoclonal Antibodies

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy

Cite this

Hide, Michihiro ; Igarashi, Atsuyuki ; Yagami, Akiko ; Chinuki, Yuko ; Inomata, Naoko ; Fukunaga, Atsushi ; Kaiser, Guenther ; Wang, Junyi ; Matsushima, Soichiro ; Greenberg, Steven ; Khalil, Sam. / Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients : Subgroup analysis of the phase 3 POLARIS study. In: Allergology International. 2018 ; Vol. 67, No. 2. pp. 243-252.
@article{ce9a15bf4b6c4c4f95497c2e12dba69e,
title = "Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients: Subgroup analysis of the phase 3 POLARIS study",
abstract = "Background: 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. 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 H1AH-refractory Japanese patients.",
author = "Michihiro Hide and Atsuyuki Igarashi and Akiko Yagami and Yuko Chinuki and Naoko Inomata and Atsushi Fukunaga and Guenther Kaiser and Junyi Wang and Soichiro Matsushima and Steven Greenberg and Sam Khalil",
year = "2018",
month = "4",
day = "1",
doi = "10.1016/j.alit.2017.10.001",
language = "English",
volume = "67",
pages = "243--252",
journal = "Allergology International",
issn = "1323-8930",
publisher = "Japanese Society of Allergology",
number = "2",

}

Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients : Subgroup analysis of the phase 3 POLARIS study. / Hide, Michihiro; Igarashi, Atsuyuki; Yagami, Akiko; Chinuki, Yuko; Inomata, Naoko; Fukunaga, Atsushi; Kaiser, Guenther; Wang, Junyi; Matsushima, Soichiro; Greenberg, Steven; Khalil, Sam.

In: Allergology International, Vol. 67, No. 2, 01.04.2018, p. 243-252.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of omalizumab for the treatment of refractory chronic spontaneous urticaria in Japanese patients

T2 - Subgroup analysis of the phase 3 POLARIS study

AU - Hide, Michihiro

AU - Igarashi, Atsuyuki

AU - Yagami, Akiko

AU - Chinuki, Yuko

AU - Inomata, Naoko

AU - Fukunaga, Atsushi

AU - Kaiser, Guenther

AU - Wang, Junyi

AU - Matsushima, Soichiro

AU - Greenberg, Steven

AU - Khalil, Sam

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Background: 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. 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 H1AH-refractory Japanese patients.

AB - Background: 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. 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 H1AH-refractory Japanese patients.

UR - http://www.scopus.com/inward/record.url?scp=85032962175&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85032962175&partnerID=8YFLogxK

U2 - 10.1016/j.alit.2017.10.001

DO - 10.1016/j.alit.2017.10.001

M3 - Article

VL - 67

SP - 243

EP - 252

JO - Allergology International

JF - Allergology International

SN - 1323-8930

IS - 2

ER -