title: Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study.
abstract: OBJECTIVE
  Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma.
  
  
  METHODS
  This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age).
  
  
  RESULTS
  A total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo.
  
  
  CONCLUSIONS
  Omalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile.
authors.affiliation: State Key Laboratory of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: Institute of Respiratory Disease, First Hospital of China Medical University, Shenyang, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Kang
authors.affiliation: Institute of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Changzheng
authors.initials: C
authors.lastname: Wang
authors.affiliation: Respiratory Franchise, Beijing Novartis Pharma Co. Ltd., Beijing, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Yang
authors.affiliation: IQS, Beijing Novartis Pharma Co. Ltd., Shanghai, China.
authors.forename: Linda
authors.initials: L
authors.lastname: Wang
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Kottakis
authors.affiliation: Respiratory Franchise, Beijing Novartis Pharma Co. Ltd., Beijing, China.
authors.forename: Michael
authors.initials: M
authors.lastname: Humphries
authors.affiliation: State Key Laboratory of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China. nanshan@vip.163.com.
authors.forename: Nanshan
authors.initials: N
authors.lastname: Zhong
keywords: Asthma; China; allergy and immunology; omalizumab; quality of life