Chest · 2025
Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Bhatt Surya P, Rabe Klaus F, Hanania Nicola A, Vogelmeier Claus F, Bafadhel Mona, Christenson Stephanie A, Papi Alberto, Singh Dave, Laws Elizabeth, Dakin Paula, Maloney Jennifer, Lu Xin, Bauer Deborah, Bansal Ashish, Abdulai Raolat M, Robinson Lacey B
Аннотация
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.
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.