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Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of ICS dose
  • +11
  • Ian Pavord,
  • Arnaud Bourdin,
  • Alberto Papi,
  • christian domingo,
  • Jonathan Corren,
  • Arman Altincatal,
  • Amr Radwan,
  • Nami Pandit-Abid,
  • Juby A. Jacob-Nara,
  • Yamo Deniz,
  • Paul Rowe,
  • Elizabeth Laws,
  • David Lederer J,
  • Megan Hardin
Ian Pavord
NIHR Oxford Biomedical Research Centre

Corresponding Author:[email protected]

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Arnaud Bourdin
Universite de Montpellier Faculte de Medecine Montpellier-Nimes
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Alberto Papi
Universita degli Studi di Ferrara
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christian domingo
Universitat Autonoma de Barcelona
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Jonathan Corren
University of California Los Angeles David Geffen School of Medicine
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Arman Altincatal
Sanofi
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Amr Radwan
Regeneron Pharmaceuticals Inc
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Nami Pandit-Abid
Sanofi
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Juby A. Jacob-Nara
Sanofi
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Yamo Deniz
Regeneron Pharmaceuticals Inc
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Paul Rowe
Sanofi
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Elizabeth Laws
Sanofi
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David Lederer J
Regeneron Pharmaceuticals Inc
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Megan Hardin
Sanofi
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Abstract

Background: Dupilumab, a human monoclonal antibody, blocks the shared receptor component for interleukins 4/13, key and central drivers of type 2 inflammation. The LIBERTY ASTHMA TRAVERSE (NCT02134028) open-label extension study demonstrated the long-term safety and efficacy of dupilumab in patients ≥12 years who had participated in a previous dupilumab asthma study. The safety profile was consistent with that observed in the parent studies. Methods: This analysis includes patients from phase 2b (NCT01854047) or phase 3 (QUEST; NCT02414854) studies receiving high- or medium-dose inhaled corticosteroids (ICS) at parent study baseline (PSBL) and enrolled in TRAVERSE. We analyzed unadjusted annualized severe exacerbation rates, change from PSBL in pre-bronchodilator (pre-BD) FEV 1 (L), asthma control (5-item asthma control questionnaire), and type 2 biomarkers in patients with type 2 asthma at baseline (blood eosinophils ≥150 cells/µL or fractional exhaled nitric oxide [FeNO] ≥25 ppb), and subgroups defined by baseline blood eosinophils or FeNO. Results: Of patients with type 2 asthma (n=1,666) in this analysis, 891 (53.5%) were receiving high‑dose ICS at PSBL. In this subgroup, unadjusted exacerbation rates for dupilumab vs placebo were 0.517 vs. 1.883 (phase 2b) and 0.571 vs. 1.300 (QUEST) over 52 weeks of the parent study, and remained low throughout TRAVERSE (0.313–0.494). Improvements in pre-BD FEV 1 from PSBL were sustained throughout TRAVERSE. Similar clinical efficacy was observed among patients receiving medium-dose ICS at PSBL and biomarker subgroups. Conclusions: Dupilumab showed sustained efficacy for up to 3 years in patients with uncontrolled, moderate-to-severe type 2 asthma on high- or medium-dose ICS.
20 Dec 2022Submitted to Allergy
20 Dec 2022Submission Checks Completed
20 Dec 2022Assigned to Editor
20 Dec 2022Review(s) Completed, Editorial Evaluation Pending
20 Dec 2022Reviewer(s) Assigned
30 Dec 2022Editorial Decision: Revise Minor
29 Apr 20231st Revision Received
29 Apr 2023Submission Checks Completed
29 Apr 2023Assigned to Editor
29 Apr 2023Review(s) Completed, Editorial Evaluation Pending
01 May 2023Reviewer(s) Assigned
09 May 2023Editorial Decision: Accept