Allergy and Airway: Asthma I |

Omalizumab Improves Asthma Symptoms, Asthma Control, and Health-Related Quality of Life in Chinese Patients With Moderate-to-Severe Asthma FREE TO VIEW

Jing Li, MD; Jian Kang; Changzheng Wang, MD; Jing Yang, PhD; Michael Humphries, MD; Steven Greenberg, MD; Nanshan Zhong, MD
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State Key Laboratory of Respiratory Disease, Guangzhou Medical University, Guangzhou, China

Copyright 2016, American College of Chest Physicians. All Rights Reserved.

Chest. 2016;149(4_S):A6. doi:10.1016/j.chest.2016.02.008
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SESSION TYPE: Original Investigation Poster

PRESENTED ON: Saturday, April 16, 2016 at 11:45 AM - 12:45 PM

PURPOSE: Omalizumab (OMA), a humanized monoclonal anti-IgE antibody, is recommended by the GINA guidelines as a step 5 therapy for the treatment of persistent moderate-to-severe allergic asthma. However, there is limited data on the management of Chinese patients (pts) with OMA. We report here the effect of OMA on asthma and symptom control, use of rescue medication and quality of life (QOL) in Chinese pts with moderate-to-severe allergic asthma.

METHODS: This was a randomized, double blind, parallel group (grp), placebo (PBO) controlled, phase 3 study which assessed morning peak expiratory flow (mPEF; primary endpoint), asthma control, asthma symptom scores, rescue medication use, asthma QOL and safety of 24 weeks (wks) of OMA therapy in adult pts from China aged 18−75 years, with moderate-to-severe persistent allergic asthma. Asthma Control Questionnaire (ACQ) scores, asthma symptom scores, rescue medication use and Asthma Quality of Life Questionnaire (AQLQ) was assessed at baseline and at wk 24.

RESULTS: A total of 608 pts were included in the full analysis set (OMA: n=306; PBO: n=302). The mean mPEF treatment difference versus PBO at Wk 24 was 8.85 L/min; p=0.062. Clinically relevant improvements in ACQ (Change from baseline =-0.51 vs. -0.34) scores were achieved after 24 wks of treatment with OMA vs. PBO. The proportion of pts achieving clinically meaningful improvements in ACQ score was 49.5% for the OMA grp vs. 35.5% for PBO (p=0.003). Statistically significant reductions were observed for total (p=0.048) and night-time symptom scores (p=0.011) with OMA vs. PBO at wk 24. The number of puffs of rescue medication during day/night decreased (Least square mean-treatment difference (LSM-TD) day/night-time=−0.16/-0.14) and the percentage of days with no rescue medication increased significantly with OMA vs. PBO (LSM-TD 5.16 [95% CI: 0.14, 10.18]: p<0.05[jv1]). The proportion of pts achieving a clinically meaningful AQLQ improvement was significantly (p<0.001) higher with OMA (58.2%) vs. PBO (39.3%). Adverse events (AE) and serious AE rates were comparable in both grps. One death from asthma exacerbation occurred in the OMA grp.

CONCLUSIONS: Omalizumab controls asthma symptoms and decreases rescue medication use in Chinese patients with moderate-to-severe persistent allergic asthma with a good safety profile.

CLINICAL IMPLICATIONS: Add-on treatment with omalizumab may prove to be an effective and well tolerated therapy option for Chinese patients with moderate-to-severe persistent allergic asthma.

DISCLOSURE: Jing Yang: Employee: Employee of Novartis Michael Humphries: Employee: Employee of Novartis Steven Greenberg: Employee: Employee of Novartis The following authors have nothing to disclose: Jing Li, Jian Kang, Changzheng Wang, Nanshan Zhong

The presenter will discuss the results of a Phase III study which investigated the efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma from China. The primary endpoint and some secondary endpoints have been discussed in various forums and congresses previously. Here, certain unpublished secondary endpoint data along with a brief discussion of the primary endpoint will be presented.




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