A1452 - Dupilumab Shows Sustained Efficacy and Improvements in Asthma Control and Health-Related Quality of Life in Patients with Moderate-to-Severe Asthma: LIBERTY ASTHMA TRAVERSE
Author Block: M. Wechsler¹, L. B. Ford², J. F. Maspero³, I. D. Pavord⁴, D. Langton⁵, C. Domingo⁶, A. Papi⁷, A. Bourdin⁸, H. Watz⁹, X. Mao¹⁰, N. Amin¹¹, M. E. Hardin¹², Y. Zhang¹¹, A. Khan¹³; ¹National Jewish Health, Denver, CO, United States, ²Asthma & Allergy Center, Bellevue, NE, United States, ³Fundación CIDEA, Buenos Aires, Argentina, ⁴Respiratory Medicine Unit, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom, ⁵Frankston Hospital, Frankston, Australia, ⁶Corporació Sanitària Parc Taulí, Sabadell, Autonomous University of Barcelona, Barcelona, Spain, ⁷Respiratory Medicine Unit, University of Ferrara, S. Anna University Hospital, Ferrara, Italy, ⁸Respiratory Diseases, Montpellier University Hospital, Montpellier, France, ⁹Pulmonary Research Institute, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Großhansdorf, Germany, ¹⁰Sanofi, Bridgewater, NJ, United States, ¹¹Regeneron Pharmaceuticals, Inc., Tarrytown, NY, United States, ¹²Sanofi, Cambridge, MA, United States, ¹³Sanofi, Chilly-Mazarin, France.
Rationale: For asthma patients, achieving asthma control and improving health-related quality of life (HRQoL) are important long-term management goals. Dupilumab is a monoclonal antibody targeting interleukin (IL)-4/IL-13, approved for the treatment of moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma. Here, we report effects of long-term use of dupilumab on asthma control and HRQoL outcomes from the TRAVERSE open-label extension (OLE) study (NCT02134028) in patients who previously completed a dupilumab asthma study (DRI or QUEST). Methods: All patients received add‑on dupilumab 300 mg every 2 weeks in the OLE. Asthma control and HRQoL were assessed up to Week 48 of the OLE using the 5-item Asthma Control Questionnaire (ACQ-5) and the self-administered 7-item Asthma Quality of Life Questionnaire (AQLQ) in patients with moderate-to-severe asthma who had participated in 24-week DRI or 52-week QUEST. Lower ACQ-5 scores (range 0─6) indicate better asthma control; higher AQLQ scores (range 0─7) indicate better HRQoL. A within-patient change of ≥0.5 in ACQ or AQLQ score is considered clinically meaningful. The overall intention-to-treat population and the type 2 asthma population, defined as patients with blood eosinophils ≥150 cells/µL or FeNO ≥25 ppb at parent study baseline (PSBL), were evaluated. Results: 2,062 patients from DRI and QUEST were enrolled into TRAVERSE. In the overall population, ACQ-5 scores (mean [standard deviation]) improved from 2.74 (0.78) at PSBL to 1.41 (1.07) at the start of OLE, which improved further to 1.11 (0.98) at Week 48 of OLE; ACQ-5 scores exceeded the clinically meaningful response threshold in 85% of patients. The largest mean improvement and percentage of patients with a clinically meaningful response was seen in the patient group who had previously received dupilumab in the parent study. AQLQ scores improved from 4.21 (1.07) at PSBL to 5.35 (1.16) at OLE baseline, with the greatest response seen in patients who previously received dupilumab in the parent study. By Week 48 of the OLE, the mean AQLQ score was 5.60 (1.10), with comparable improvements for all treatment groups; 77% of all patients showed clinically meaningful improvements (Table). Comparable improvements in these scores were also seen in the type 2 asthma patient population. The safety profile during the OLE was similar to that observed in the parent study populations. Conclusions: Patients with moderate-to-severe asthma who were treated with dupilumab demonstrated substantial and sustained improvement in their asthma control and HRQoL during the 48-week TRAVERSE OLE study, supporting the efficacy seen in the parent studies.