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; Klaus F Rabe; Nicola A Hanania; Claus F Vogelmeier; Mona Bafadhel; Stephanie A Christenson; Alberto Papi; Dave Singh; Elizabeth Laws; Paula Dakin; Jennifer Maloney; Xin Lu; Deborah Bauer; Ashish Bansal; Raolat M Abdulai; Lacey B Robinson

doi:10.1016/j.chest.2025.01.029

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, Klaus F Rabe, Nicola A Hanania, Claus F Vogelmeier, Mona Bafadhel, Stephanie A Christenson, Alberto Papi, Dave Singh, Elizabeth Laws, Paula Dakin, Jennifer Maloney, Xin Lu, Deborah Bauer, Ashish Bansal, Raolat M Abdulai, Lacey B Robinson

Peter Gorer Department of Immunobiology

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	56-66
Number of pages	11
Journal	Chest
Volume	168
Issue number	1
Early online date	31 Jan 2025
DOIs	https://doi.org/10.1016/j.chest.2025.01.029
Publication status	Published - Jul 2025

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Bhatt, S. P., Rabe, K. F., Hanania, N. A., Vogelmeier, C. F., Bafadhel, M., Christenson, S. A., Papi, A., Singh, D., Laws, E., Dakin, P., Maloney, J., Lu, X., Bauer, D., Bansal, A., Abdulai, R. M., & Robinson, L. B. (2025). Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS. Chest, 168(1), 56-66. https://doi.org/10.1016/j.chest.2025.01.029

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

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.",

author = "Bhatt, {Surya P} and Rabe, {Klaus F} and Hanania, {Nicola A} and Vogelmeier, {Claus F} and Mona Bafadhel and Christenson, {Stephanie A} and Alberto Papi and Dave Singh and Elizabeth Laws and Paula Dakin and Jennifer Maloney and Xin Lu and Deborah Bauer and Ashish Bansal and Abdulai, {Raolat M} and Robinson, {Lacey B}",

year = "2025",

month = jul,

doi = "10.1016/j.chest.2025.01.029",

language = "English",

volume = "168",

pages = "56--66",

journal = "Chest",

issn = "0012-3692",

publisher = "American College of Chest Physicians",

number = "1",

}

Bhatt, SP, Rabe, KF, Hanania, NA, Vogelmeier, CF, Bafadhel, M, Christenson, SA, Papi, A, Singh, D, Laws, E, Dakin, P, Maloney, J, Lu, X, Bauer, D, Bansal, A, Abdulai, RM & Robinson, LB 2025, 'Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS', Chest, vol. 168, no. 1, pp. 56-66. https://doi.org/10.1016/j.chest.2025.01.029

TY - JOUR

T1 - Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation

T2 - BOREAS and NOTUS

AU - Bhatt, Surya P

AU - Rabe, Klaus F

AU - Hanania, Nicola A

AU - Vogelmeier, Claus F

AU - Bafadhel, Mona

AU - Christenson, Stephanie A

AU - Papi, Alberto

AU - Singh, Dave

AU - Laws, Elizabeth

AU - Dakin, Paula

AU - Maloney, Jennifer

AU - Lu, Xin

AU - Bauer, Deborah

AU - Bansal, Ashish

AU - Abdulai, Raolat M

AU - Robinson, Lacey B

PY - 2025/7

Y1 - 2025/7

N2 - 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.

AB - 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.

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U2 - 10.1016/j.chest.2025.01.029

DO - 10.1016/j.chest.2025.01.029

M3 - Article

C2 - 39894389

SN - 0012-3692

VL - 168

SP - 56

EP - 66

JO - Chest

JF - Chest

IS - 1

ER -

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

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