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Browse ATS 2021 Abstracts

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ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.

Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.

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Long-Term Dupilumab Treatment in Moderate-to-Severe Asthma with Type 2 Inflammation: Open Label LIBERTY ASTHMA TRAVERSE Study

Session Title
D7 - D007 ADVANCES IN ASTHMA THERAPIES
Abstract
A1201 - Long-Term Dupilumab Treatment in Moderate-to-Severe Asthma with Type 2 Inflammation: Open Label LIBERTY ASTHMA TRAVERSE Study
Author Block: M. Wechsler1, I. D. Pavord2, A. Papi3, K. R. Chapman4, X. Mao5, B. Ortiz6, M. Djandji7, M. K. Ruddy6, E. Laws8, N. Amin6, D. J. Lederer6, M. E. Hardin7; 1National Jewish Health, Denver, CO, United States, 2Respiratory Medicine Unit, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom, 3Respiratory Medicine Unit, University of Ferrara, S. Anna University Hospital, Ferrara, Italy, 4Asthma & Airway Centre, University of Toronto, Toronto, ON, Canada, 5Sanofi, Bridgewater, NJ, United States, 6Regeneron Pharmaceuticals, Inc., Tarrytown, NY, United States, 7Sanofi, Cambridge, MA, United States, 8Immunology & Inflammation, Sanofi, Bridgewater, NJ, United States.
Rationale: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL-4/IL-13, key and central drivers of type 2 inflammation in multiple diseases. In QUEST (NCT02414854), asthma patients with type 2 inflammation as evidenced by elevated blood eosinophils or fractional exhaled nitric oxide (FeNO) demonstrated a significant response to dupilumab. TRAVERSE (NCT02134028), a single-arm open-label extension study, evaluated the long-term safety, tolerability and efficacy of dupilumab added-on to standard of care in adult/adolescents who participated in a previous dupilumab asthma study (DRI, EXPEDITION, QUEST, or VENTURE). This post hoc analysis of TRAVERSE assessed the long-term efficacy of dupilumab in the subset of asthma patients with type 2 inflammation who enrolled after completing QUEST. Methods: Annualized rate of severe exacerbations (AER), change from parent study baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 96, and change from parent study baseline in 5-item Asthma Control Questionnaire (ACQ-5) and Asthma Quality of Life Questionnaire (AQLQ) scores at Week 48 were analyzed in patient subgroups with blood eosinophils/µL of ≥300 cells/µL, ≥150 cells/µL, FeNO ≥25 ppb, and patients with either eosinophils ≥150 cells/µL or FeNO ≥25 ppb at parent study baseline. Results: Of the 1,902 patients originally enrolled in QUEST, 1,530 (80.4%) rolled over to TRAVERSE. Consistent with the on-treatment results of the parent study, low unadjusted AER was maintained over a treatment period of up to 96 weeks in each type 2 subpopulation regardless of receiving placebo or dupilumab in the parent study; dupilumab/dupilumab groups showed greater reductions in exacerbation rates compared with the placebo/dupilumab groups (Table). In a separate subgroup of dupilumab patients enrolled from QUEST with either ≥150 eosinophils/µL or FeNO ≥25ppb at baseline who completed 3 full years of treatment, rate of severe exacerbations decreased progressively over 3 years, from 0.42 during QUEST, to 0.31 and 0.23 during the first and second year of TRAVERSE, respectively. The pre-bronchodilator FEV1 improvements observed in the parent study were sustained during TRAVERSE with no loss of treatment effect (Table). Improvements in ACQ-5 and AQLQ scores were also maintained (Table). Conclusion: Dupilumab demonstrated sustained efficacy for up to 3 years in patients with a type 2 asthma phenotype, as identified by either elevated FeNO or blood eosinophils. The findings were consistent with the parent study, where a similar rapid onset of response was observed in patients who had received placebo during the parent study.