P62: DUPILUMAB DEMONSTRATES RAPID AND SUSTAINED IMPROVEMENTS IN DAILY ASTHMA-RELATED SYMPTOMS IN PATIENTS WITH UNCONTROLLED, MODERATE-TO-SEVERE ASTHMA: DATA FROM THE LIBERTY ASTHMA QUEST STUDY

Abstract

Jo Douglass¹, David Langton², Jonathan Corren³, Mario Castro⁴, Sophie Guillonneau⁵, Jingdong Chao⁶, Nikhil Amin⁶, Neil MH Graham⁶, Ariel Teper⁷ and Asif Khan⁷

¹Melbourne Health and the University of Melbourne, Melbourne, Victoria, Australia

²Peninsula Health, Melbourne, Victoria, Australia

³David Geffen School of Medicine at UCLA, Los Angeles, CA, USA

⁴Washington University School of Medicine, Saint Louis, MO, USA

⁵Sanofi, Chilly-Mazarin, France

⁶Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA

⁷Sanofi, Bridgewater, NJ, USA

Dupilumab (DPL), a fully human interleukin (IL)-4Rα mAb, inhibits IL-4/IL-13 signalling, key drivers of Type 2 inflammation. In the phase 3 LIBERTY ASTHMA QUEST study (NCT02414854), DPL 200mg/300mg administered every 2 weeks versus matched placebo (PBO) reduced annualized severe exacerbation rates, improved lung function, and was generally well tolerated in adults and adolescents with uncontrolled, moderate-to-severe asthma. Improvements in asthma control and quality of life were observed as early as Week 2 and sustained throughout the 52-week treatment period. This pre-specified analysis evaluates DPL's effect on asthma-related symptoms.

Symptoms were recorded daily by electronic diary; symptoms occurring during the night (AM) and day (PM) were scored on a 5-point Likert-like scale from 0 (no asthma symptoms) to 4 (more severe symptoms). Changes from baseline in symptoms at Weeks 2 and 52 were assessed for DPL versus PBO. Correlations between symptom scores and 5-item Asthma Control Questionnaire (ACQ-5) and Asthma Quality of Life Questionnaire (AQLQ) scores were assessed by Pearson's correlation coefficient.

DPL 200 mg/300 mg rapidly improved AM (P≤0.05) and PM (P ≤ 0.01) symptom scores versus PBO at Week 2 (Table). AM/PM symptom scores continued to improve throughout the 52-week treatment period (P ≤ 0.01). At Week 52, moderate correlations were observed between change in AM/PM symptom scores and change in ACQ-5/AQLQ scores in the PBO and DPL groups. The most frequent adverse event in the DPL group was injection site reactions (15% and 18%; versus placebo, 5% and 10%, respectively).

Add-on dupilumab rapidly improves morning and evening asthma symptoms in adolescents and adults with uncontrolled, moderate-to-severe asthma. Improvements in symptom scores were maintained during the 52 weeks’ treatment and moderately correlated with improvements in asthma control and quality of life.