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.
[1]China Japan Friendship Hosp, Ctr Resp Med, Dept Pulm & Crit Care Med, Beijing, Peoples R China.
[2]Natl Ctr Resp Med, Beijing, Peoples R China.
[3]Shandong First Med Univ, Shandong Prov Qianfoshan Hosp, Affiliated Hosp 1, Shandong Inst Resp Dis,Dept Allergy, Jinan, Peoples R China.
[4]Weifang Peoples Hosp, Dept Allergy, Weifang, Shandong, Peoples R China.
[5]Chengdu First Peoples Hosp, Dept Pulm & Crit Care Med, Chengdu, Peoples R China.
[6]Guangzhou Med Univ, Affiliated Hosp 1, Guangzhou Inst Resp Hlth, Natl Clin Res Ctr Resp Dis,Natl Ctr Resp Med,Dept, Guangzhou, Peoples R China.
[7]Shanxi Med Univ, Shanxi Bethune Hosp, Hosp 3, Tongji Shanxi Hosp,Dept Pulm & Crit Care Med, Taiyuan, Shanxi, Peoples R China.
[8]Capital Med Univ, Beijing Shijitan Hosp, Allergy Ctr, Beijing, Peoples R China.
[9]Tangshan Gongren Hosp, Dept Allergy, Tangshan, Hebei, Peoples R China.
[10]Suzhou Univ, Affiliated Hosp 1, Dept Resp & Crit Care Med, Suzhou, Jiangsu, Peoples R China.
[11]Panzhihua Integrated Chinese & Western Med Hosp, Dept Pulm & Crit Care Med, Panzhihua, Sichuan, Peoples R China.
[12]Novartis Pharmaceut, Resp Clin Med 2, E Hanover, NJ USA.
[13]Novartis Pharmaceut, Analyt Global Hlth, E Hanover, NJ USA.
[14]Beijing Novartis Pharm Co Ltd, Neurosci & Resp Dev Unit, Beijing, Peoples R China.
[15]China Novartis Inst Biomed Res Co Ltd, Resp Clin Dev, Beijing, Peoples R China.
[16]Novartis Inst Biomed Res Co Ltd, Shanghai, Peoples R China.
[17]Beijing Novartis Pharm Co Ltd, New Prod, Shanghai, Peoples R China.
[18]Natl Clin Res Ctr Resp Dis, Beijing, Peoples R China.
[19]Chinese Acad Med Sci, Inst Resp Med, Beijing, Peoples R China.
[20]Chinese Acad Med Sci & Peking Union Med Coll, Beijing, Peoples R China.
[21]Capital Med Univ, Dept Resp Med, Beijing, Peoples R China.
[22]China Japan Friendship Hosp, 2 East Yinghua Rd, Beijing 100029, Peoples R China.
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