These materials are presented by Sanofi and Regeneron Medical for scientific exchange purposes only. Please refer to the package insert for full SmPC. Sanofi will not foster the application of our medicinal products in a way outside of the approved indication. Please always refer to the SmPC approved in your country before prescribing dupilumab.
^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.

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