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
Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL.
LungenClinic Grosshansdorf and Christian Albrechts University of Kiel, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Chest. 2025 Jul;168(1):56-66. doi: 10.1016/j.chest.2025.01.029. Epub 2025 Jan 31.
Patient-reported outcomes should be considered alongside clinical assessments to guide therapy for COPD.
Does add-on dupilumab treatment improve health-related quality of life and respiratory symptoms in patients with COPD and type 2 inflammation?
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.
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]).
Dupilumab exhibited improvements in SGRQ and E-RS:COPD total and domain scores in patients with COPD and type 2 inflammation.
ClinicalTrials.gov Identifiers; Numbers: NCT03930732 and NCT04456673; URL: www.
gov.
在指导慢性阻塞性肺疾病（COPD）的治疗时，应将患者报告的结局与临床评估一并考虑。
在患有COPD和2型炎症的患者中，添加度普利尤单抗治疗是否能改善健康相关生活质量和呼吸道症状？
在这项对两项3期试验的汇总分析中，接受三联疗法的COPD和2型炎症患者按1:1随机分组，每2周接受一次300 mg度普利尤单抗（n = 938）或安慰剂（n = 936）治疗，共52周。生活质量和呼吸道症状严重程度通过圣乔治呼吸问卷（SGRQ；总分[0 - 100分，分数越低表明生活质量越好]以及症状、活动和影响方面的领域得分）和慢性阻塞性肺疾病呼吸症状评估量表（E-RS:COPD；总分[0 - 40分，分数越低意味着呼吸道症状越轻]以及气促、咳嗽和咳痰、胸部症状方面的领域得分）从基线到第52周的变化来衡量。
总共1660名患者达到第52周（每个治疗组各830名）。在第52周时，度普利尤单抗组与安慰剂组相比，SGRQ和E-RS:COPD总分的最小二乘均值差异（95%CI）分别为-3.4（-5.0至-1.8；P <.0001）和-0.9（-1.4至-0.4；P =.0006）有所降低。在SGRQ症状（-3.5 [-5.5至-1.5]）、活动（-4.0 [-5.9至-2.1]）和影响（-2.9 [-4.6至-1.1]）的领域得分以及E-RS:COPD气促（-0.6 [-0.8至-0.3]）、咳嗽和咳痰（-0.2 [-0.3至0.0]）和胸部症状（-0.1 [-0.3至0.0]）的领域得分中也观察到了类似的降低。
度普利尤单抗可改善患有COPD和2型炎症患者的SGRQ和E-RS:COPD总分及领域得分。
ClinicalTrials.gov标识符；编号：NCT03930732和NCT04456673；网址：www. ClinicalTrials.gov 。
