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Journal of Asthma and Allergy Volume 16, 2023 - Issue
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ORIGINAL RESEARCH

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

Nan Su1 Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, Beijing, People’s Republic of China;2 National Center of Respiratory Medicine, Beijing, People’s Republic of ChinaView further author information
,
Lili Zhi3 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 ChinaView further author information
,
Fengxia Liu4 Department of Allergy, Weifang People’s Hospital, Weifang, Shandong, People’s Republic of ChinaView further author information
,
Yongsheng Wang5 Department of Pulmonary and Critical Care Medicine, Chengdu First People’s Hospital, Chengdu, People’s Republic of ChinaView further author information
,
Qingling Zhang6 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 ChinaView further author information
,
Xiansheng Liu7 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 ChinaORCID Iconhttps://orcid.org/0000-0002-9598-5054View further author information
ORCID Icon,
Xueyan Wang8 Allergy Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, People’s Republic of ChinaView further author information
,
Guodong Hao9 Department of Allergy, Tangshan Gongren Hospital, Tangshan, Hebei, People’s Republic of ChinaView further author information
,
Xiuqin Zhang10 Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, People’s Republic of ChinaView further author information
,
Qiang Hu11 Department of Pulmonary and Critical Care Medicine, Panzhihua Integrated Chinese and Western Medicine Hospital, Panzhihua, Sichuan, People’s Republic of ChinaORCID Iconhttps://orcid.org/0009-0008-6980-7407View further author information
ORCID Icon,
Monica Ligueros-Saylan12 Respiratory Clinical/Medical 2, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAView further author information
,
Alkaz Uddin13 Analytics - Global Health DU, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAView further author information
,
Jing Yang14 Neuroscience & Respiratory Development Unit, Beijing Novartis Pharma. Co. Ltd, Beijing, People’s Republic of ChinaView further author information
,
Tiantian Liang15 Respiratory Clinical Development, China Novartis Institutes for BioMedical Research Co., Ltd, Beijing, People’s Republic of ChinaView further author information
,
Liju Ding16 GCTM-Group-2, China Novartis Institutes for BioMedical Research Co., Ltd, Shanghai, People’s Republic of ChinaView further author information
,
Runqin Li17 New Products, Beijing Novartis Pharma. Co. Ltd, Shanghai, People’s Republic of ChinaView further author information
&
Chen Wang1 Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, Beijing, People’s Republic of China;2 National Center of Respiratory Medicine, Beijing, People’s Republic of China;18 National Clinical Research Center for Respiratory Diseases, Beijing, People's Republic of China;19 Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China;20 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China;21 Department of Respiratory Medicine, Capital Medical University, Beijing, People's Republic of ChinaCorrespondence[email protected]
View further author information
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Pages 625-636 | Received 24 Feb 2023, Accepted 02 Jun 2023, Published online: 19 Jun 2023

References

  • Holgate ST, Djukanović R, Casale T, Bousquet J. Anti-immunoglobulin E treatment with omalizumab in allergic diseases: an update on anti-inflammatory activity and clinical efficacy. Clin Exp Allergy. 2005;35(4):408–416. doi:10.1111/j.1365-2222.2005.02191.x
  • Global Initiative for Asthma. Global strategy for asthma management and prevention revised 2014; 2014. Available from: https://ginasthma.org/wp-content/uploads/2019/01/2014-GINA.pdf. Accessed July 28, 2022.
  • Lee JK, Amin S, Erdmann M, et al. Real-world observational study on the characteristics and treatment patterns of allergic asthma patients receiving omalizumab in Canada. Patient Prefer Adherence. 2020;14:725–735. doi:10.2147/PPA.S248324
  • Huang K, Yang T, Xu J, et al. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019;394(10196):407–418. doi:10.1016/S0140-6736(19)31147-X
  • Global Asthma Network. The global asthma report 2018; 2018. Available from: www.globalasthmanetwork.org. Accessed July 12, 2022.
  • Wang P, Wang L, Ni Q, Shi G. Factors of high asthma expenditure in China: an 1-year retrospective study. Value Health. 2018;21:S104. doi:10.1016/j.jval.2018.07.788
  • Schatz M, Rosenwasser L. The allergic asthma phenotype. J Allergy Clin Immunol. 2014;2(6):645–648.
  • Novak N, Bieber T. Allergic and nonallergic forms of atopic diseases. J Allergy Clin Immunol. 2003;112(2):252–262. doi:10.1067/mai.2003.1595
  • Mao D, Tang R, Wu R, et al. Prevalence trends in the characteristics of patients with allergic asthma in Beijing, 1994 to 2014. Medicine. 2017;96:22.
  • Platt-mills TAE. The role of immunoglobulin E in allergy and asthma. Am J Respir Crit Care Med. 2001;164:51–55.
  • Omalizumab [package insert]. South San Francisco, CA: Genentech, Inc; 2021. Available from: www.fda.gov/medwatch. Accessed June 06, 2023.
  • Omalizumab 75 mg Solution. Summary of product characteristics (SPC) - (eMC); 2021. Availabe from: https://www.medicines.org.uk/emc/product/5327/ampc#gref. Accessed August 18, 2022.
  • Xolair (omalizumab). Data on file. Safety update. Period covered; 2018.
  • Li J, Kang J, Wang C, et al. Omalizumab improves quality of life and asthma control in Chinese patients with moderate to severe asthma: a randomized Phase III study. Allergy Asthma Immunol Res. 2016;8(4):319–328. doi:10.4168/aair.2016.8.4.319
  • Chan J. Novartis’ asthma therapy Xolair gets approval in China; 2017. Available from: https://www.spglobal.com/marketintelligence/en/news-insights/trending/ygigsltbpjsgzlzabvyzfq2. Accessed July 3, 2022.
  • Lloyd A, Turk F, Leighton T, Canonica W. Psychometric evaluation of global evaluation of treatment effectiveness: a tool to assess patients with moderate-to-severe allergic asthma. J Med Econ. 2007;10(3):285–296. doi:10.3111/13696990701478856
  • Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma quality of life questionnaire. Eur Respir J. 1999;14:32–38. doi:10.1034/j.1399-3003.1999.14a08.x
  • Juniper EF, Guyatt GH, Feeny DH, et al. Measuring quality of life in children with asthma. Qual Life Res. 1996;5(1):35–46. doi:10.1007/BF00435967
  • Zhang M, Jin M, Zhou X, et al. Effectiveness of omalizumab in patients with severe allergic asthma: a retrospective study in China. Respir Med. 2021;186:106522. doi:10.1016/j.rmed.2021.106522
  • Braunstahl GJ, Chen CW, Maykut R, Georgiou P, Peachey G, Bruce J. The eXpeRience registry: the “real-world” effectiveness of omalizumab in allergic asthma. Respir Med. 2013;107(8):1141–1151. doi:10.1016/j.rmed.2013.04.017
  • Bhutani M, Yang WH, Hébert J, De Takacsy F, Stril JL. The real world effect of omalizumab add on therapy for patients with moderate to severe allergic asthma: the ASTERIX observational study. PLoS One. 2017;12(8):e0183869. doi:10.1371/journal.pone.0183869
  • Luskin AT, Chipps BE, Rasouliyan L, Miller DP, Haselkorn T, Dorenbaum A. Impact of asthma exacerbations and asthma triggers on asthma-related quality of life in patients with severe or difficult-to-treat asthma. J Allergy Clin Immunol Pract. 2014;2(5):544–552.e2. doi:10.1016/j.jaip.2014.02.011
  • Adachi M, Kozawa M, Yoshisue H, et al. Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: a long-term post-marketing study in Japan. Respir Med. 2018;141:56–63. doi:10.1016/j.rmed.2018.06.021
  • Di Bona D, Fiorino I, Taurino M, et al. Long-term “real-life” safety of omalizumab in patients with severe uncontrolled asthma: a nine-year study. Respir Med. 2017;130:55–60. doi:10.1016/j.rmed.2017.07.013

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