Dupilumab improves respiratory symptoms in patients with moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS trial

<bold>BACKGROUND:</bold> IL-4 and IL-13 are key and central drivers of type 2 inflammation. Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for IL-4 and IL-13, improved health-related quality of life and COPD symptoms in the phase 3 BOREAS trial (<ext-link>NCT03930732</ext-link>). This analysis evaluates the effect of dupilumab on daily symptom burden using the Evaluating Respiratory Symptoms in COPD (E-RS™:COPD) tool by domain. <bold>METHODS:</bold> In BOREAS, patients with moderate-to-severe airflow limitation and type 2 inflammation (screening blood eosinophils ≥300 cells/µL), on triple therapy, received add-on dupilumab 300mg q2w or placebo for 52 weeks. E-RS domain scores (total, breathlessness, chest symptoms, cough and sputum) were evaluated in patients on a daily basis, to determine weekly average scores, from baseline up to Week 52. <bold>RESULTS:</bold> In the ITT population, E-RS:COPD total score change from baseline at Week 52 for dupilumab (n=468) vs placebo (n=471) was significantly greater (least squares [LS] mean difference –1.137; <italic>P</italic>=0.0012). Compared to placebo, dupilumab demonstrated nominally significant improvements in all 3 E-RS:COPD domains by Week 52 <bold>(Figure)</bold>. Dupilumab demonstrated an acceptable safety profile. <bold>CONCLUSIONS:</bold> Dupilumab improved daily symptom frequency and severity in all E-RS:COPD total and domains for patients with COPD and type 2 inflammation in BOREAS. <fig><object-id>erj;64/suppl_68/PA4786/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa4786
Citations
1
Primary Topic
Chronic Obstructive Pulmonary Disease (COPD) Research
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article
Field-Weighted Citation Impact
0.42
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article

Dupilumab improves respiratory symptoms in patients with moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS trial

Elizabeth Laws, Mona Bafadhel, Nicola A. Hanania, Jennifer Maloney et al.
1 citations
Chronic Obstructive Pulmonary Disease (COPD) Research
0.42
article

Dupilumab improves respiratory symptoms in patients with moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS trial

Elizabeth Laws, Mona Bafadhel, Nicola A. Hanania, Jennifer Maloney, Klaus F. Rabe, Alberto Papi, Lacey B. Robinson, Surya Prakash Bhatt, Claus Franz Vogelmeier, Ashish Bansal, Xin Lu, Raolat M. Abdulai, Dave Singh, Stephanie A. Christenson, Deborah Bauer
article en
1 citations

Abstract

<bold>BACKGROUND:</bold> IL-4 and IL-13 are key and central drivers of type 2 inflammation. Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for IL-4 and IL-13, improved health-related quality of life and COPD symptoms in the phase 3 BOREAS trial (<ext-link>NCT03930732</ext-link>). This analysis evaluates the effect of dupilumab on daily symptom burden using the Evaluating Respiratory Symptoms in COPD (E-RS™:COPD) tool by domain. <bold>METHODS:</bold> In BOREAS, patients with moderate-to-severe airflow limitation and type 2 inflammation (screening blood eosinophils ≥300 cells/µL), on triple therapy, received add-on dupilumab 300mg q2w or placebo for 52 weeks. E-RS domain scores (total, breathlessness, chest symptoms, cough and sputum) were evaluated in patients on a daily basis, to determine weekly average scores, from baseline up to Week 52. <bold>RESULTS:</bold> In the ITT population, E-RS:COPD total score change from baseline at Week 52 for dupilumab (n=468) vs placebo (n=471) was significantly greater (least squares [LS] mean difference –1.137; <italic>P</italic>=0.0012). Compared to placebo, dupilumab demonstrated nominally significant improvements in all 3 E-RS:COPD domains by Week 52 <bold>(Figure)</bold>. Dupilumab demonstrated an acceptable safety profile. <bold>CONCLUSIONS:</bold> Dupilumab improved daily symptom frequency and severity in all E-RS:COPD total and domains for patients with COPD and type 2 inflammation in BOREAS. <fig><object-id>erj;64/suppl_68/PA4786/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>

University of California, San Francisco (US), Baylor College of Medicine (US), King's College London (GB), University of Ferrara (IT), University of Alabama at Birmingham (US), AVEO Oncology (United States) (US), Manchester University NHS Foundation Trust (GB), Sanofi (United States) (US), Progenics Pharmaceuticals (United States) (US), German Center for Lung Research (DE), LungenClinic Grosshansdorf (DE), University of San Francisco (US)
Openalex Percentile: Top 31%
Chronic Obstructive Pulmonary Disease (COPD) Research
0.42
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