PMID- 37360967 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230701 IS - 1178-6965 (Print) IS - 1178-6965 (Electronic) IS - 1178-6965 (Linking) VI - 16 DP - 2023 TI - Real-World Safety and Effectiveness of Omalizumab in Moderate to Severe Allergic Asthma Patients in China: A Post-Authorization Study. PG - 625-636 LID - 10.2147/JAA.S406628 [doi] AB - PURPOSE: Omalizumab was first approved in China in 2017 for the treatment of moderate to severe allergic asthma for adult and adolescent patients aged >/=12 years. In accordance with the Chinese Health Authority requirement, the post-authorization safety study (PASS) was conducted to evaluate the safety and effectiveness of omalizumab in a real-world setting in patients with moderate to severe allergic asthma in China over a 24-week observation period. PATIENTS AND METHODS: This is a single-arm, non-interventional, multicenter, PASS conducted in adult, adolescent, and pediatric patients (>/=6 years old) with moderate to severe allergic asthma receiving omalizumab in a real-world clinical setting from 2020 to 2021 in 59 sites of mainland China. RESULTS: In total, 1546 patients were screened and 1528 were enrolled. They were stratified according to age (6 to <12 years [n = 191]; >/=12 years [n = 1336]; unknown [n = 1]). Among the overall population, 23.6% and 4.5% of patients reported adverse events (AEs) and serious adverse events (SAEs), respectively. Among pediatric patients (6 to <12 years), 14.1% and 1.6% patients reported AEs and SAEs, respectively. AEs that led to treatment discontinuation in both age groups were <2%. No new safety signals were reported. Effectiveness results showed improvement in lung function, asthma control, and quality of life (QoL). CONCLUSION: The findings of the current study demonstrated that the safety profile of omalizumab was consistent with its known profile in allergic asthma, and no new safety signals were reported. Omalizumab treatment was effective in improving the lung function and QoL in patients with allergic asthma. CI - (c) 2023 Su et al. FAU - Su, Nan AU - Su N AD - Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, Beijing, People's Republic of China. AD - National Center of Respiratory Medicine, Beijing, People's Republic of China. FAU - Zhi, Lili AU - Zhi L AD - Department of Allergy, Shandong Provincial Qianfoshan Hospital, The First Affiliated Hospital of Shandong First Medical University, Shandong Institute of Respiratory Diseases, Jinan, People's Republic of China. FAU - Liu, Fengxia AU - Liu F AD - Department of Allergy, Weifang People's Hospital, Weifang, Shandong, People's Republic of China. FAU - Wang, Yongsheng AU - Wang Y AD - Department of Pulmonary and Critical Care Medicine, Chengdu First People's Hospital, Chengdu, People's Republic of China. FAU - Zhang, Qingling AU - Zhang Q AD - Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, State Key Laboratory of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China. FAU - Liu, Xiansheng AU - Liu X AUID- ORCID: 0000-0002-9598-5054 AD - Department of Pulmonary and Critical Care Medicine, Shanxi Bethune Hospital, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, People's Republic of China. FAU - Wang, Xueyan AU - Wang X AD - Allergy Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, People's Republic of China. FAU - Hao, Guodong AU - Hao G AD - Department of Allergy, Tangshan Gongren Hospital, Tangshan, Hebei, People's Republic of China. FAU - Zhang, Xiuqin AU - Zhang X AD - Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, People's Republic of China. FAU - Hu, Qiang AU - Hu Q AUID- ORCID: 0009-0008-6980-7407 AD - Department of Pulmonary and Critical Care Medicine, Panzhihua Integrated Chinese and Western Medicine Hospital, Panzhihua, Sichuan, People's Republic of China. FAU - Ligueros-Saylan, Monica AU - Ligueros-Saylan M AD - Respiratory Clinical/Medical 2, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. FAU - Uddin, Alkaz AU - Uddin A AD - Analytics - Global Health DU, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. FAU - Yang, Jing AU - Yang J AD - Neuroscience & Respiratory Development Unit, Beijing Novartis Pharma. Co. Ltd, Beijing, People's Republic of China. FAU - Liang, Tiantian AU - Liang T AD - Respiratory Clinical Development, China Novartis Institutes for BioMedical Research Co., Ltd, Beijing, People's Republic of China. FAU - Ding, Liju AU - Ding L AD - GCTM-Group-2, China Novartis Institutes for BioMedical Research Co., Ltd, Shanghai, People's Republic of China. FAU - Li, Runqin AU - Li R AD - New Products, Beijing Novartis Pharma. Co. Ltd, Shanghai, People's Republic of China. FAU - Wang, Chen AU - Wang C AD - Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, Beijing, People's Republic of China. AD - National Center of Respiratory Medicine, Beijing, People's Republic of China. AD - National Clinical Research Center for Respiratory Diseases, Beijing, People's Republic of China. AD - Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. AD - Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. AD - Department of Respiratory Medicine, Capital Medical University, Beijing, People's Republic of China. LA - eng PT - Journal Article DEP - 20230619 PL - New Zealand TA - J Asthma Allergy JT - Journal of asthma and allergy JID - 101543450 PMC - PMC10289103 OTO - NOTNLM OT - adverse drug events OT - allergic asthma OT - effectiveness OT - omalizumab OT - safety COIS- Monica Ligueros-Saylan, Alkaz Uddin, Jing Yang, Tiantian Liang, Liju Ding, and Runqin Li are/were employees of Novartis during the time of the study and the manuscript writing. The authors report no other conflicts of interest in this work. EDAT- 2023/06/26 19:07 MHDA- 2023/06/26 19:08 PMCR- 2023/06/19 CRDT- 2023/06/26 12:45 PHST- 2023/02/24 00:00 [received] PHST- 2023/06/02 00:00 [accepted] PHST- 2023/06/26 19:08 [medline] PHST- 2023/06/26 19:07 [pubmed] PHST- 2023/06/26 12:45 [entrez] PHST- 2023/06/19 00:00 [pmc-release] AID - 406628 [pii] AID - 10.2147/JAA.S406628 [doi] PST - epublish SO - J Asthma Allergy. 2023 Jun 19;16:625-636. doi: 10.2147/JAA.S406628. eCollection 2023.