Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China
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 grou...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | World Allergy Organization Journal |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1939455122000953 |
| _version_ | 1797980316620554240 |
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| author | Ao Wang, MD Yuhui Yun, MM Zhihua Wen, MM Yingxia Gao, BS Shuzhen Qi, MD Yu Zhang, MD Yunsheng Liang, MD Xu Yao, MD |
| author_facet | Ao Wang, MD Yuhui Yun, MM Zhihua Wen, MM Yingxia Gao, BS Shuzhen Qi, MD Yu Zhang, MD Yunsheng Liang, MD Xu Yao, MD |
| author_sort | Ao Wang, MD |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-04-11T05:53:40Z |
| format | Article |
| id | doaj.art-dac56918325c4f1fabb9b0da6dcf55e2 |
| institution | Directory Open Access Journal |
| issn | 1939-4551 |
| language | English |
| last_indexed | 2024-04-11T05:53:40Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | World Allergy Organization Journal |
| spelling | doaj.art-dac56918325c4f1fabb9b0da6dcf55e22022-12-22T04:42:00ZengElsevierWorld Allergy Organization Journal1939-45512022-12-011512100719Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from ChinaAo Wang, MD0Yuhui Yun, MM1Zhihua Wen, MM2Yingxia Gao, BS3Shuzhen Qi, MD4Yu Zhang, MD5Yunsheng Liang, MD6Xu Yao, MD7Department 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. ChinaDepartment of Dermatology, Dermatology Hospital, Southern Medical University, Guangzhou 510091, P.R. ChinaDepartment 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. ChinaDepartment 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. ChinaSTD Clinic, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, P.R. ChinaDepartment 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.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.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.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).http://www.sciencedirect.com/science/article/pii/S1939455122000953Chronic spontaneous urticariaOmalizumabTherapyEfficacyPediatric patients |
| spellingShingle | Ao Wang, MD Yuhui Yun, MM Zhihua Wen, MM Yingxia Gao, BS Shuzhen Qi, MD Yu Zhang, MD Yunsheng Liang, MD Xu Yao, MD Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China World Allergy Organization Journal Chronic spontaneous urticaria Omalizumab Therapy Efficacy Pediatric patients |
| title | Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China |
| title_full | Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China |
| title_fullStr | Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China |
| title_full_unstemmed | Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China |
| title_short | Efficacy and safety of omalizumab against chronic spontaneous urticaria: Real-world study from China |
| title_sort | efficacy and safety of omalizumab against chronic spontaneous urticaria real world study from china |
| topic | Chronic spontaneous urticaria Omalizumab Therapy Efficacy Pediatric patients |
| url | http://www.sciencedirect.com/science/article/pii/S1939455122000953 |
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