Real-World Safety and Effectiveness of Omalizumab in Moderate to Severe Allergic Asthma Patients in China: A Post-Authorization Study

Abstract

Nan Su,1,2 Lili Zhi,3 Fengxia Liu,4 Yongsheng Wang,5 Qingling Zhang,6 Xiansheng Liu,7 Xueyan Wang,8 Guodong Hao,9 Xiuqin Zhang,10 Qiang Hu,11 Monica Ligueros-Saylan,12 Alkaz Uddin,13 Jing Yang,14 Tiantian Liang,15 Liju Ding,16 Runqin Li,17 Chen Wang1,2,18– 21 1Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, Beijing, People’s Republic of China; 2National Center of Respiratory Medicine, Beijing, People’s Republic of China; 3Department 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; 4Department of Allergy, Weifang People’s Hospital, Weifang, Shandong, People’s Republic of China; 5Department of Pulmonary and Critical Care Medicine, Chengdu First People’s Hospital, Chengdu, People’s Republic of China; 6Department 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; 7Department 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; 8Allergy Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, People’s Republic of China; 9Department of Allergy, Tangshan Gongren Hospital, Tangshan, Hebei, People’s Republic of China; 10Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, People’s Republic of China; 11Department of Pulmonary and Critical Care Medicine, Panzhihua Integrated Chinese and Western Medicine Hospital, Panzhihua, Sichuan, People’s Republic of China; 12Respiratory Clinical/Medical 2, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 13Analytics - Global Health DU, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 14Neuroscience & Respiratory Development Unit, Beijing Novartis Pharma. Co. Ltd, Beijing, People’s Republic of China; 15Respiratory Clinical Development, China Novartis Institutes for BioMedical Research Co., Ltd, Beijing, People’s Republic of China; 16GCTM-Group-2, China Novartis Institutes for BioMedical Research Co., Ltd, Shanghai, People’s Republic of China; 17New Products, Beijing Novartis Pharma. Co. Ltd, Shanghai, People’s Republic of China; 18National Clinical Research Center for Respiratory Diseases, Beijing, People’s Republic of China; 19Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China; 20Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China; 21Department of Respiratory Medicine, Capital Medical University, Beijing, People’s Republic of ChinaCorrespondence: Chen Wang, China- Japan Friendship Hospital, No. 2, East Yinghua Road, Chaoyang District, Beijing, 100029, People’s Republic of China, Tel [phone], Fax [phone], Email [email protected]: 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.Keywords: adverse drug events, allergic asthma, safety, effectiveness, omalizumab

Keywords

• adverse drug events
• allergic asthma
• safety
• effectiveness
• omalizumab