학술논문
Dupilumab sustains efficacy in patients with moderate-to-severe type 2 asthma regardless of inhaled corticosteroids dose.
Document Type
Academic Journal
Author
Pavord ID; NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.; Bourdin A; Department of Respiratory Diseases, University of Montpellier, Montpellier, France.; Papi A; Respiratory Medicine Unit, University of Ferrara, S. Anna University Hospital, Ferrara, Italy.; Domingo C; Pulmonary Service, Corporació Sanitària Parc Taulí, Sabadell, Autonomous University of Barcelona, Barcelona, Spain.; Corren J; David Geffen School of Medicine at UCLA, Los Angeles, California, USA.; Altincatal A; Sanofi, Cambridge, Massachusetts, USA.; Radwan A; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.; Pandit-Abid N; Sanofi, Bridgewater, New Jersey, USA.; Jacob-Nara JA; Sanofi, Bridgewater, New Jersey, USA.; Deniz Y; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.; Rowe PJ; Sanofi, Bridgewater, New Jersey, USA.; Laws E; Sanofi, Bridgewater, New Jersey, USA.; Lederer DJ; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.; Hardin M; Sanofi, Cambridge, Massachusetts, USA.
Source
Publisher: Wiley-Blackwell Country of Publication: Denmark NLM ID: 7804028 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1398-9995 (Electronic) Linking ISSN: 01054538 NLM ISO Abbreviation: Allergy Subsets: MEDLINE
Subject
Language
English
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 TRAVERSE (NCT02134028) open-label extension study demonstrated the long-term safety and efficacy of dupilumab in patients ≥12 years who completed a previous dupilumab asthma study. The safety profile was consistent with that observed in the parent studies. Here, we assess whether dupilumab sustains long-term efficacy in patients regardless of inhaled corticosteroid (ICS) dose at parent study baseline (PSBL).
Methods: Patients from phase 2b (NCT01854047) or phase 3 (QUEST; NCT02414854) studies receiving high- or medium-dose ICS at PSBL and enrolled in TRAVERSE were included. We analyzed unadjusted annualized severe exacerbation rates, change from PSBL in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1 ), 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 = 1666), 891 (53.5%) were receiving high-dose ICS at PSBL. In this subgroup, unadjusted exacerbation rates for dupilumab versus placebo were 0.517 versus 1.883 (phase 2b) and 0.571 versus 1.300 (QUEST) over the parent study (52 weeks) and remained low throughout TRAVERSE (0.313-0.494). Improvements in pre-BD FEV1 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.
(© 2023 Sanofi and The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)
Methods: Patients from phase 2b (NCT01854047) or phase 3 (QUEST; NCT02414854) studies receiving high- or medium-dose ICS at PSBL and enrolled in TRAVERSE were included. We analyzed unadjusted annualized severe exacerbation rates, change from PSBL in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV
Results: Of patients with type 2 asthma (n = 1666), 891 (53.5%) were receiving high-dose ICS at PSBL. In this subgroup, unadjusted exacerbation rates for dupilumab versus placebo were 0.517 versus 1.883 (phase 2b) and 0.571 versus 1.300 (QUEST) over the parent study (52 weeks) and remained low throughout TRAVERSE (0.313-0.494). Improvements in pre-BD FEV
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.
(© 2023 Sanofi and The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)