DUPILUMAB REDUCES EXACERBATIONS WHILE IMPROVING LUNG FUNCTION AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND TYPE 2 INFLAMMATION, REGARDLESS OF SMOKING STATUS
Author(s)
Surya P Bhatt, MD1, Guy Brusselle, MD2, Helena Backman, MD3, Alberto Papi, MD4, Hisatoshi Sugiura, MD5, Henrik Watz, MD6, Paramita Saha-Chaudhuri, MD7, Mena Soliman, MD8, Jigna Heble, Pharm D9, Jadwiga A Wedzicha, MD10.
1University of Alabama at Birmingham, Birmingham, AL, USA, 2Ghent University Hospital, Ghent, Belgium, 3Umeå University, Umeå, Sweden, 4Respiratory Medicine Unit, University of Ferrara, Ferrara, Italy, 5Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan, 6Velocity Clinical Research Germany, Ahrensburg, Germany; 7University of Lübeck, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Lübeck, Germany, 7Sanofi, Mississauga, ON, Canada, 8Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 9Sanofi, Morristown, NJ, USA, 10National Heart and Lung Institute, Imperial College London, London, United Kingdom.
1University of Alabama at Birmingham, Birmingham, AL, USA, 2Ghent University Hospital, Ghent, Belgium, 3Umeå University, Umeå, Sweden, 4Respiratory Medicine Unit, University of Ferrara, Ferrara, Italy, 5Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan, 6Velocity Clinical Research Germany, Ahrensburg, Germany; 7University of Lübeck, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Lübeck, Germany, 7Sanofi, Mississauga, ON, Canada, 8Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 9Sanofi, Morristown, NJ, USA, 10National Heart and Lung Institute, Imperial College London, London, United Kingdom.
OBJECTIVES: Medications demonstrate reduced efficacy in patients with COPD who continue to smoke. Some patients may lack access to certain medications due to ongoing smoking. In BOREAS and NOTUS studies, dupilumab reduced exacerbations and improved lung function and quality of life in patients with COPD and type 2 inflammation. This post-hoc analysis evaluates dupilumab's efficacy in former and current smokers with COPD.
METHODS: Phase 3 BOREAS (NCT03930732) and NOTUS (NCT04456673) enrolled patients with moderate-to-severe COPD and type 2 inflammation (screening eosinophils ≥300 cells/µL) on triple therapy. Patients received add-on dupilumab 300 mg every 2 weeks or placebo for 52 weeks. Endpoints were annualized moderate or severe exacerbation rate, and changes in lung function (pre-bronchodilator forced expiratory volume in 1 second [FEV1]) and quality of life (St. George's Respiratory Questionnaire [SGRQ]), stratified by baseline smoking status (former vs current smokers).
RESULTS: Former (dupilumab: n=662; placebo: n=654) and current smokers (dupilumab: n=276; placebo: n=282) were included. Dupilumab reduced exacerbations by 32% in former (relative risk vs placebo [95% confidence interval (CI)]: 0.7 [0.6, 0.8]; P<0.001) and by 31% in current smokers (0.7 [0.5, 0.9]; P=0.005). Week 12: dupilumab improved pre-bronchodilator FEV1 in former (Least squares [LS] mean difference vs placebo [95% CI]: 88 mL [50, 126]; P<0.001) and current smokers (64 mL [19, 109]; P=0.005); interaction P value: 0.36. Week 52: dupilumab improved SGRQ scores in former (LS mean difference vs placebo [95% CI]: -3.6 points [-5.5, -1.6]; P<0.001) and current smokers (-2.03 points [-4.7, 0.6]; P=0.13); interaction P value: 0.21.
CONCLUSIONS: Dupilumab reduced exacerbations, and improved lung function and quality of life in patients with COPD and type 2 inflammation, regardless of baseline smoking status. These findings support the efficacy of dupilumab, particularly for current smokers with limited therapeutic options.
METHODS: Phase 3 BOREAS (NCT03930732) and NOTUS (NCT04456673) enrolled patients with moderate-to-severe COPD and type 2 inflammation (screening eosinophils ≥300 cells/µL) on triple therapy. Patients received add-on dupilumab 300 mg every 2 weeks or placebo for 52 weeks. Endpoints were annualized moderate or severe exacerbation rate, and changes in lung function (pre-bronchodilator forced expiratory volume in 1 second [FEV1]) and quality of life (St. George's Respiratory Questionnaire [SGRQ]), stratified by baseline smoking status (former vs current smokers).
RESULTS: Former (dupilumab: n=662; placebo: n=654) and current smokers (dupilumab: n=276; placebo: n=282) were included. Dupilumab reduced exacerbations by 32% in former (relative risk vs placebo [95% confidence interval (CI)]: 0.7 [0.6, 0.8]; P<0.001) and by 31% in current smokers (0.7 [0.5, 0.9]; P=0.005). Week 12: dupilumab improved pre-bronchodilator FEV1 in former (Least squares [LS] mean difference vs placebo [95% CI]: 88 mL [50, 126]; P<0.001) and current smokers (64 mL [19, 109]; P=0.005); interaction P value: 0.36. Week 52: dupilumab improved SGRQ scores in former (LS mean difference vs placebo [95% CI]: -3.6 points [-5.5, -1.6]; P<0.001) and current smokers (-2.03 points [-4.7, 0.6]; P=0.13); interaction P value: 0.21.
CONCLUSIONS: Dupilumab reduced exacerbations, and improved lung function and quality of life in patients with COPD and type 2 inflammation, regardless of baseline smoking status. These findings support the efficacy of dupilumab, particularly for current smokers with limited therapeutic options.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO83
Topic
Clinical Outcomes, Patient-Centered Research, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)