Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma

作     者：Leonard B Bacharier 

作者机构：From Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville (L.B.B.) Fundación CIDEA Buenos Aires (J.F.M.) Campbelltown Hospital Campbelltown NSW and Western Sydney University Sydney (C.H.K.) - both in Australia Bambino Gesù Children's Hospital IRCCS Rome (A.G.F.) Clinique Spécialisée en Allergie de la Capitale Quebec QC Canada (R.G.) Hospital Vall d'Hebron Barcelona (I.M.) Arizona Allergy and Immunology Research Gilbert (N.J.) Peninsula Research Associates Rolling Hills Estates CA (L.D.S.) Sanofi Bridgewater NJ (X.M. U.K. P.J.R. E.L.) Sanofi Beijing (D.L.) Regeneron Pharmaceuticals Tarrytown NY (Y.Z. F.A.K. Y.D. M.R. D.M.W. G.D.Y. N.A. D.J.L.) Sanofi Chilly-Mazarin France (A.H.K. L.P.M.) and Sanofi Genzyme Cambridge MA (N.P. M.H.). 

出 版 物：《四川生理科学杂志》 (Sichuan Journal of Physiological Sciences)

年 卷 期：2021年第43卷第10期

页      面：1816-1816页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：Sanofi Regeneron Pharmaceuticals 

主　　题：millimeter cubic continued 

摘      要：Background:Children with moderate-to-severe asthma continue to have disease complications despite the receipt of standardof-care *** monoclonal antibody dupilumab has been approved for the treatment of adults and adolescents with asthma as well as with other type 2 inflammatory ***:In this 52-week phase 3,randomized,double-blind,placebo-controlled trial,we assigned 408 children between the ages of 6 and 11 years who had uncontrolled moderate-to-severe asthma to receive a subcutaneous injection of dupilumab(at a dose of 100 mg for those weighing≤30 kg and 200 mg for those weighing30 kg)or matched placebo every 2 *** the children continued to receive a stable dose of standard background *** primary end point was the annualized rate of severe asthma *** end points included the change from baseline in the percentage of predicted prebronchodilator forced expiratory volume in 1 second(ppFEV1)at week 12 and in the score on the Asthma Control Questionnaire 7 Interviewer-Administered(ACQ-7-IA)at week *** points were evaluated in the two primary efficacy populations who had either a type 2 inflammatory asthma phenotype(≥150 blood eosinophils per cubic millimeter or a fraction of exhaled nitric oxide of≥20 ppb at baseline)or a blood eosinophil count of at least 300 cells per cubic millimeter at baseline.