Efficacy and safety of omalizumab in patients with moderate-to-severe asthma: An analytic comparison of data from randomized controlled trials between Chinese and Caucasians
Jing Li,1 Jing Yang,2 Lingfei Kong,3 Yijiang Huang,4 Ping Chen,5 Xixin Yan,6 Xiaoxia Liu,7 Xiangdong Zhou,8 Jinming Liu,9 Xiaoli Zhu,10 Michael Humphries,2 Linda Wang,11 Abhijit Pethe,12 Xinting Wang,12 Ioannis Kottakis,13 Robert Fogel,14 Nanshan Zhong1
1 State Key Laboratory of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China
2 Novartis China Global Drug Development, China
3 The First Affiliated Hospital, China Medical University, Shenyang, China
4 Affiliated Hospital to Hainan Medical University, Haikou, China
5 General Military Hospital, Shenyang, China
6 Second Affiliated Hospital of Hebei Medical University, Hebei Sheng, China
7 Beijing Friendship Hospital of Capital Medical University, Beijing Shi, China
8 Xinan Hospital, Third Military Medical University, Chongqing, China
9 Shanghai Pulmonary Hospital of Tongji University, Shanghai, China
10 Zhongda Hospital of Southeast University, Nanjing China
11 Biostatistics & Pharmacometrics, NIBR, China
12 Biostatistics & Pharmacometrics, Novartis Pharmaceuticals, USA
13 Global Medical Affairs Novartis Pharma AG, Basel, Switzerland
14 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA
Abstract
Background: Omalizumab has > 15 years of real-world evidence of effectiveness in Caucasian patients. In August 2017, it was approved as an add-on therapy for the management of moderate-to-severe asthma in China.
Objective: To compare the efficacy and safety of omalizumab in Chinese and Caucasian patients.
Methods: This analysis included clinical trial data from a Chinese study (NCT01202903) and four studies with predominantly Caucasian patients (008, 009, EXTRA and INNOVATE). The following outcomes were analyzed: change from baseline in morning peak expiratory flow (mPEF), percentage predicted forced expiratory volume in one second (FEV1), patient-reported outcomes (PROs), asthma exacerbation and safety. Further, a population pharmacokinetic/pharmacodynamic (PK/PD) was also assessed.
Results: In the Chinese study, omalizumab significantly improved the mPEF from baseline vs placebo at Weeks > 4–8 through > 16–20; however, the change in mPEF did not reach statistical significance at Week 24. A similar trend towards improvement in mPEF was observed in the studies with Caucasians (INNOVATE, 008 and 009). In all studies, omalizumab showed greater improvement in %predicted FEV1, AQLQ score, and GETE score vs placebo. In addition, asthma symptom scores and seasonal exacerbations were lower, especially during winter, in the Chinese study, and was comparable to studies in Caucasians. PK/PD analyses showed that steady-state PK of omalizumab; free or total immunoglobulin E levels were similar in all studies.
Conclusions: The clinical efficacy and safety of omalizumab was comparable among Chinese and Caucasian patients with moderate-to-severe asthma supporting therapeutic effectiveness, irrespective of race, ethnicity and geographical factors.
Key words: Asthma, omalizumab, Caucasian, Chinese, comparative analysis,