51. Dupilumab efficacy and safety in moderate-to-severe uncontrolled Asthma
- Author
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Yuji Tohda, Nikhil Amin, Bingzhi Zhang, George D. Yancopoulos, Jorge Maspero, William W. Busse, Ian D. Pavord, Marcella Ruddy, Jingdong Chao, Linda B. Ford, Brian N. Swanson, Gianluca Pirozzi, Sally E. Wenzel, Bolanle Akinlade, Jonathan Corren, J. Mark FitzGerald, Ariel Teper, Klaus F. Rabe, Mario Castro, Neil Stahl, Lawrence Sher, Jennifer D. Hamilton, Constance H. Katelaris, Asif Khan, Renata Martincova, Neil M.H. Graham, and Heribert Staudinger
- Subjects
0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Exacerbation ,Adolescent ,medicine.drug_class ,Injections, Subcutaneous ,Population ,Antibodies, Monoclonal, Humanized ,03 medical and health sciences ,chemistry.chemical_compound ,Young Adult ,0302 clinical medicine ,Reslizumab ,Double-Blind Method ,Internal medicine ,Bronchodilator ,Forced Expiratory Volume ,Eosinophilia ,medicine ,Humans ,Anti-Asthmatic Agents ,education ,Child ,Asthma ,education.field_of_study ,Intention-to-treat analysis ,Interleukin-13 ,business.industry ,Antibodies, Monoclonal ,General Medicine ,Middle Aged ,medicine.disease ,Benralizumab ,Dupilumab ,Bronchodilator Agents ,Intention to Treat Analysis ,Receptors, Interleukin-4 ,030104 developmental biology ,030228 respiratory system ,chemistry ,Drug Therapy, Combination ,Female ,business ,medicine.drug - Abstract
Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. We assessed its efficacy and safety in patients with uncontrolled asthma.We randomly assigned 1902 patients 12 years of age or older with uncontrolled asthma in a 2:2:1:1 ratio to receive add-on subcutaneous dupilumab at a dose of 200 or 300 mg every 2 weeks or matched-volume placebos for 52 weeks. The primary end points were the annualized rate of severe asthma exacerbations and the absolute change from baseline to week 12 in the forced expiratory volume in 1 second (FEV1) before bronchodilator use in the overall trial population. Secondary end points included the exacerbation rate and FEV1 in patients with a blood eosinophil count of 300 or more per cubic millimeter. Asthma control and dupilumab safety were also assessed.The annualized rate of severe asthma exacerbations was 0.46 (95% confidence interval [CI], 0.39 to 0.53) among patients assigned to 200 mg of dupilumab every 2 weeks and 0.87 (95% CI, 0.72 to 1.05) among those assigned to a matched placebo, for a 47.7% lower rate with dupilumab than with placebo (P
- Published
- 2018
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