Qingling Zhang, Nanshan Zhong, Sahajal Dhooria, Xiuhua Fu, Haohui Fang, Jie Lin, Shuyang Zhu, Elizabeth Laws, Yi Wang, Vivian Li, Chih-Chi Hu, Jennifer Maloney, Raolat M Abdulai, Lacey B Robinson
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引用次数: 0
Abstract
Background: Asthma prevalence is increasing in the Asia-Pacific region. China and India account for > 35% of the world's population and are often underrepresented in clinical studies. This phase 3 study (NCT03782532) evaluated efficacy and safety of dupilumab, a monoclonal antibody blocking interleukin-4/13 signalling, in patients with persistent asthma from China and India.
Methods: Patients (≥ 12 years) were randomised 1:1 to dupilumab 200 mg or matched placebo every 2 weeks for 24 weeks (primary analysis population: blood eosinophils ≥ 150 cells/μL or fractional exhaled nitric oxide ≥ 25 parts per billion without maintenance oral corticosteroid [OCS]; OCS maintenance population: 300 mg OCS).
Primary endpoint: change from baseline to week 12 in forced expiratory volume in 1 s (FEV1). Secondary endpoints: change from baseline to week 24 in 5-item Asthma Control Questionnaire (ACQ-5/7) scores, annualised severe exacerbation rate, and safety.
Results: In the primary analysis population (n = 414), change in FEV1 by week 12 was significantly greater for dupilumab versus placebo (least squares mean difference: 0.31 L [95% CI: 0.23-0.39]; p < 0.0001). At week 24, greater reductions in ACQ-5 score were seen for dupilumab versus placebo (least squares mean difference: -0.20 [95% CI: -0.35 to -0.05]; p = 0.0097). Dupilumab reduced severe exacerbation risk by 62% versus placebo during the treatment period (relative risk: 0.38 [95% CI: 0.21-0.70]; nominal p = 0.002). Safety was similar between treatment arms; injection-site reactions were more common with dupilumab treatment (5.0%) than with placebo (1.2%). The OCS maintenance population showed similar outcomes.
Conclusion: Dupilumab significantly improved lung function and asthma control, numerically reduced asthma exacerbations, and was well tolerated in patients from China and India with persistent asthma and evidence of either type 2 inflammation or OCS maintenance.
期刊介绍：
Clinical & Experimental Allergy strikes an excellent balance between clinical and scientific articles and carries regular reviews and editorials written by leading authorities in their field.
In response to the increasing number of quality submissions, since 1996 the journals size has increased by over 30%. Clinical & Experimental Allergy is essential reading for allergy practitioners and research scientists with an interest in allergic diseases and mechanisms. Truly international in appeal, Clinical & Experimental Allergy publishes clinical and experimental observations in disease in all fields of medicine in which allergic hypersensitivity plays a part.
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