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Clinical Trial
. 2025 Jul;168(1):56-66.
doi: 10.1016/j.chest.2025.01.029. Epub 2025 Jan 31.

Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS

Surya P Bhatt  1 , Klaus F Rabe  2 , Nicola A Hanania  3 , Claus F Vogelmeier  4 , Mona Bafadhel  5 , Stephanie A Christenson  6 , Alberto Papi  7 , Dave Singh  8 , Elizabeth Laws  9 , Paula Dakin  10 , Jennifer Maloney  10 , Xin Lu  11 , Deborah Bauer  11 , Ashish Bansal  10 , Raolat M Abdulai  9 , Lacey B Robinson  9
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Free article
Clinical Trial

Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS

Surya P Bhatt et al. Chest. 2025 Jul.
Free article

Abstract

Background: Patient-reported outcomes should be considered alongside clinical assessments to guide therapy for COPD.

Research question: Does add-on dupilumab treatment improve health-related quality of life and respiratory symptoms in patients with COPD and type 2 inflammation?

Study design and methods: In this pooled analysis of two phase 3 trials, patients with COPD and type 2 inflammation receiving triple therapy were randomized 1:1 to receive dupilumab 300 mg (n = 938) or placebo (n = 936) every 2 weeks for 52 weeks. Quality of life and respiratory symptom severity were measured by change from baseline to week 52 in St. George's Respiratory Questionnaire (SGRQ; total [0-100 units, lower scores indicating better quality of life] and domain scores for symptoms, activity, and impacts) and Evaluating Respiratory Symptoms in COPD (E-RS:COPD; total [0-40 units, lower scores meaning less severe respiratory symptoms] and domain scores for breathlessness, cough and sputum, and chest symptoms) scores.

Results: In total, 1,660 patients reached week 52 (n = 830 in each treatment arm). At week 52, dupilumab vs placebo reduced SGRQ and E-RS:COPD total scores by least squares mean differences (95% CI) of -3.4 (-5.0 to -1.8; P < .0001) and -0.9 (-1.4 to -0.4; P = .0006), respectively. Similar reductions were observed across SGRQ domain scores of symptoms (-3.5 [-5.5 to -1.5]), activity (-4.0 [-5.9 to -2.1]), and impacts (-2.9 [-4.6 to -1.1]), and E-RS:COPD domain scores of breathlessness (-0.6 [-0.8 to -0.3]), cough and sputum (-0.2 [-0.3 to 0.0]), and chest symptoms (-0.1 [-0.3 to 0.0]).

Interpretation: Dupilumab exhibited improvements in SGRQ and E-RS:COPD total and domain scores in patients with COPD and type 2 inflammation.

Clinical trial registration: ClinicalTrials.gov Identifiers; Numbers: NCT03930732 and NCT04456673; URL: www.

Clinicaltrials: gov.

Keywords: COPD; patient-reported outcomes; quality of life; respiratory symptoms; type 2 inflammation.

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Conflict of interest statement

Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: S. P. B. reports grant support from the National Institutes of Health; consultancy fees from Apreo, Boehringer Ingelheim, Chiesi, Genentech, GSK, Regeneron Pharmaceuticals Inc., and Sanofi; and honoraria from Horizon CME, Integrity CE, and Medscape. K. F. R. reports consultancy and speaker fees from and participation in advisory boards with AstraZeneca, Boehringer Ingelheim, Chiesi, Gilead, GSK, Novartis, Pearl, Sanofi, and Teva; and is co-founder of rnatics. N. A. H. reports consultancy or advisory fees from Amgen, AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Sanofi, and Teva; and institutional grant support from AstraZeneca, Boehringer Ingelheim, Genentech, GSK, Novartis, and Sanofi. C. F. V. reports speaker fees from and/or participation in advisory boards for Aerogen, AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, Grifols, GSK, Insmed, Menarini, Novartis, Nuvaira, Roche, and Sanofi. M. B. reports institutional grant support from AstraZeneca and Roche; consultancy and speaker fees from AstraZeneca, Chiesi, and GSK; and scientific advisory fees from Albus Health and ProAxsis. S. A. C. reports grant support from Merck and the National Institutes of Health; consultancy fees from AstraZeneca, Glenmark Pharmaceuticals, and GSK; honoraria from AstraZeneca, Genentech, Sanofi/Regeneron Pharmaceuticals Inc., and Sunovion; and participation on advisory/data and safety monitoring boards for AstraZeneca, Glenmark Pharmaceuticals, GSK, and Sanofi-Regeneron Pharmaceuticals Inc. A. P. reports institutional payments from AstraZeneca, Chiesi, GSK, and Sanofi; consultancy fees from AstraZeneca, Avillion, Chiesi, Elpen Pharmaceuticals, GSK, IQVIA, Novartis, and Sanofi; and honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events from AstraZeneca, Avillion, Chiesi, Edmond Pharma, Elpen Pharmaceuticals, GSK, IQVIA, Menarini, MSD, Mundipharma, Sanofi, and Zambon. D. S. reports consultancy fees and honoraria from Aerogen, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, CSL Behring, EpiEndo, Genentech, Glenmark Pharmaceuticals, Gossamer Bio, GSK, Kinaset Therapeutics, Menarini, Novartis, Orion, Pulmatrix, Sanofi, Teva, Theravance Biopharma, and Verona Pharma. E. L., X. L., D. B., and L. B. R. are employees of Sanofi and may hold stock and/or stock options in the company. R. M. A. is a former employee of Sanofi and may hold stock and/or stock options in the company. P. D., J. M., and A. B. are employees and shareholders of Regeneron Pharmaceuticals Inc.

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