LIBERTY ASTHMA QUEST Trial: Dupilumab Evidence Summary in Moderate-to-Severe Uncontrolled Asthma

Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma

Castro M, et al. N Engl J Med. 2018;378(26):2486–2496 

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^aDefined as all randomized patients by allocated treatment regardless of whether or not treatment was received. ^bPlease see manuscript for full details. ^cICS and controller dose for ≥3 months with a stable dose of ICS ≥1 month. ^dAll baseline characteristics are mean unless otherwise stated. ^eHigher scores indicate less control. ^fEndpoints were not part of the hierarchical testing order, and as such were not multiplicity controlled. ^gHigher scores indicate better quality of life. ^hTEAE eosinophilia was automatic if blood EOS.
were >3000 cells/μL during study or at investigator discretion. Reported clinical symptoms per MedDRA HLT eosinophilic disorders only. An additional 2 TEAEs were deemed potentially related to eosinophilia with concomitant rise in blood EOS >3000 cells/μL.
ACQ-5, 5-item Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; HLT, high level term; ICS, inhaled corticosteroids; IgE, immunoglobulin E; ITT, intent-to-treat; LS, least squares; MeDRA, Medical Dictionary for Regulatory Activities; pp, per predicted; ppb, parts per billion; Pre-BD FEV₁, pre bronchodilator forced expiratory volume in 1 second; q2w, every 2 weeks; SmPC, Summary of Product Characteristics; URTI, upper respiratory tract infection; TEAE, treatment-emergent adverse event.