Allergy Asthma Immunol Res.  2016 Jul;8(4):319-328. 10.4168/aair.2016.8.4.319.

Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study

• Li J
• Kang J
• Wang C
• Yang J
• Wang L
• Kottakis I
• Humphries
• Zhong N
• China Omalizumab Study Group

• KMID: 2165915
• DOI: http://doi.org/10.4168/aair.2016.8.4.319

Abstract

PURPOSE
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.

Keyword

Asthma; omalizumab; allergy and immunology; quality of life; China

MeSH Terms

Allergy and Immunology
Asian Continental Ancestry Group*
Asthma*
China
Humans
Least-Squares Analysis
Lung
Quality of Life*
Omalizumab

Figure

• 

  Fig. 1 (A) Study design and (B) patient disposition. One administrative problem in the omalizumab group was due to drug administration being performed incorrectly. For the placebo group, 4 administrative problems were due to incorrect administration of omalizumab instead of placebo. The above cases were considered as protocol deviation.

• 

  Fig. 2 Analysis of lung function following 24 weeks of treatment. (A) mean mPEF (L/min), (B) FEV1 % predicted. Data is presented as LSM-TD of omalizumab vs placebo for mPEF and LSM treatment values±SEM for FEV1 % predicted. FAS, full analysis set; FEV1, forced expiratory volume in 1 second; LSM-TD, least square mean-treatment difference; PP, per-protocol set; PEF, peak expiratory flow; SEM, standard error of mean.

• 

  Fig. 3 Analysis of changes from baseline in ACQ scores (full analysis set). Data is presented as LSM values±SEM from full analysis set. Patients with not more than 1 item missing are included with the missing item being imputed by interpolation (approximately 30% of patients in both treatment groups had missing ACQ data). ACQ, asthma control questionnaire; LSM, least squares mean; SEM, standard error of mean.

• 

  Fig. 4 Analysis of changes from baseline following 24 weeks of treatment in (A) asthma symptom scores and (B) asthma rescue medication. Data is presented as LSM treatment values±SEM from the full analysis set. LSM, least squares mean; SEM, standard error of mean.

• 

  Fig. 5 Analysis of change from baseline in the AQLQ(S) scores (full analysis set). Data is presented as LSM treatment values±SEM from the full analysis set. Patients with not more than 1 item missing are included with the missing item being imputed by interpolation (approximately 40% of patients in both the treatment groups had missing AQLQ(S) data). AQLQ(S), asthma quality of life questionnaire; LSM, least squares mean; SEM, standard error of mean.

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