Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China

Ao Wang, MD; Yuhui Yun, MM; Zhihua Wen, MM; Yingxia Gao, BS; Shuzhen Qi, MD; Yu Zhang, MD; Yunsheng Liang, MD; Xu Yao, MD

World Allergy Organization Journal (Dec 2022)

Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China

Ao Wang, MD,
Yuhui Yun, MM,
Zhihua Wen, MM,
Yingxia Gao, BS,
Shuzhen Qi, MD,
Yu Zhang, MD,
Yunsheng Liang, MD,
Xu Yao, MD

Affiliations

Ao Wang, MD: Department of Allergy and Rheumatology, Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, P.R. China
Yuhui Yun, MM: Department of Dermatology, Dermatology Hospital, Southern Medical University, Guangzhou 510091, P.R. China
Zhihua Wen, MM: Department of Allergy and Rheumatology, Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, P.R. China
Yingxia Gao, BS: Department of Allergy and Rheumatology, Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, P.R. China
Shuzhen Qi, MD: STD Clinic, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, P.R. China
Yu Zhang, MD: Department of Allergy and Rheumatology, Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, P.R. China; Corresponding author. Department of Allergy and Rheumatology, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, No.12 Jiangwangmiao Street, Xuanwu District, Nanjing city, Jiangsu Province, China.
Yunsheng Liang, MD: Department of Dermatology, Dermatology Hospital, Southern Medical University, Guangzhou 510091, P.R. China; Corresponding author. Department of Dermatology, Dermatology Hospital, Southern Medical University, No.2, Lujing Rd, Guangzhou 510091, China.
Xu Yao, MD: Department of Allergy and Rheumatology, Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, P.R. China; Corresponding author. Department of Allergy and Rheumatology, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, No.12 Jiangwangmiao Street, Xuanwu District, Nanjing city, Jiangsu Province, China.

Journal volume & issue: Vol. 15, no. 12
p. 100719

Abstract

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Background: Omalizumab is an effective treatment for chronic spontaneous urticaria (CSU) patients aged ≥12 years, but its efficacy in patients aged <12 years has not been fully documented. We evaluated the therapeutic efficacy and safety of omalizumab in Chinese CSU population across all age groups. Objectives: To assess the efficacy and safety of omalizumab treatment against CSU in China. Methods: This study was a retrospective and observational study, and the clinical data of CSU patients treated with omalizumab from October 2018 to August 2021 were collected and analyzed. Results: We enrolled 235 patients in this study, and 54.0% (n = 127/235) of patients were female. All patients received at least three injections of omalizumab treatment, and the mean treatment duration was 3.4 ± 1.0 months. At the end of week-12, 98.7% (n = 232/235) of patients responded to omalizumab, among which 91.1% (n = 214/235) achieved a complete response (CR). An excellent response to omalizumab treatment was observed across all ages. All patients aged <12 years (n = 26) achieved a CR at the end of week-12, and clinical improvement was maintained until treatment cessation. Eighty-seven patients received 3–9-month follow-up after the end of treatment, with a mean duration of 5.7 ± 2.0 months, and 17.2% (n = 15/87) patients experienced recurrence after discontinuing treatment. No factors associated with therapeutic response and recurrence to omalizumab treatment were found in this study. Conclusion: Omalizumab is a safe and efficacious therapy for CSU patients, including those aged <12 years. We recommend addition of omalizumab to the treatment regimen in CSU patients under 12 years of age. Trial registration number: This study was registered in Chinese Clinical Trial Registry (www.chictr.org.cn, Registration number: ChiCTR2200056599).

Published in World Allergy Organization Journal

ISSN: 1939-4551 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Immunologic diseases. Allergy
Website: https://www.sciencedirect.com/journal/world-allergy-organization-journal

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