EFFICACY OF DUPILUMAB IN PATIENTS HOSPITALIZED DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE EXACERBATION: PHASE 4 MISSION TRIAL DESIGN
Author(s)
Sanjay Ramakrishnan, MD1, Shawn Aaron, MD2, Surya P Bhatt, MD3, Christopher E. Brightling, MD4, Wim Janssens, MD5, Frits M.E Franssen, MD6, Mona Bafadhel, MD7, Amy Pitts, MD8, Changming Xia, MD8, Isabelle Malbouisson, MD9, Michael Zhang, MD8, Mena Soliman, MD8, Gerard J Criner, MD10.
1Institute for Respiratory Health, University of Western Australia, Perth, WA, Australia, 2The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada, 3University of Alabama at Birmingham, Birmingham, AL, USA, 4University of Leicester, Leicester, United Kingdom, 5University Hospitals Leuven, Leuven, Belgium, 6Maastricht University Medical Center, Maastricht, Netherlands, 7King’s Centre for Lung Health, King’s College London, London, United Kingdom, 8Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 9Sanofi, Cambridge, MA, USA, 10Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
1Institute for Respiratory Health, University of Western Australia, Perth, WA, Australia, 2The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada, 3University of Alabama at Birmingham, Birmingham, AL, USA, 4University of Leicester, Leicester, United Kingdom, 5University Hospitals Leuven, Leuven, Belgium, 6Maastricht University Medical Center, Maastricht, Netherlands, 7King’s Centre for Lung Health, King’s College London, London, United Kingdom, 8Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, 9Sanofi, Cambridge, MA, USA, 10Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
OBJECTIVES: Patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation, who were hospitalized due to a COPD exacerbation, have an increased risk of readmission and mortality compared with those hospitalized without type 2 inflammation. Add-on dupilumab has been shown to reduce exacerbations and improve lung function and patient-reported outcomes in patients with COPD and type 2 inflammation. MISSION aims to assess whether dupilumab treatment can reduce hospital readmissions and exacerbation rates in patients hospitalized for COPD exacerbations.
METHODS: MISSION, a phase 4, randomized, double-blind, placebo-controlled, multinational trial will enroll former and current smokers (aged ≥40 years) with COPD hospitalized due to an acute exacerbation event with elevated blood eosinophil count (≥300 cells/µL) at the index event, post-bronchodilator forced expiratory volume in 1 second/forced vital capacity ratio <0.7, and on triple therapy, or dual inhaled therapy when inhaled corticosteroids are contraindicated. Patients will be randomized to add-on dupilumab 300 mg every 2 weeks or matching placebo for 90 days.
RESULTS: There are two multiplicity-controlled primary outcomes: 1) time to first all-cause non-elective hospital readmission, emergency department visit, or death; 2) number of moderate or severe exacerbations, from the date of randomization to Day 90. Secondary outcomes include the time to first COPD-related hospital readmission, emergency department visit or death, and the time to first moderate or severe exacerbation, from baseline to Day 90. The change in Chronic Airways Assessment Test, and Exacerbations of Chronic Pulmonary Disease Tool from baseline to Weeks 3, 5, 9, and end of the trial, and the occurrence of treatment-emergent adverse events and serious adverse events from baseline through the last trial visit will also be assessed.
CONCLUSIONS: MISSION will evaluate the efficacy of dupilumab vs placebo in lowering hospital readmissions and exacerbation risk in patients with COPD and type 2 inflammation.
METHODS: MISSION, a phase 4, randomized, double-blind, placebo-controlled, multinational trial will enroll former and current smokers (aged ≥40 years) with COPD hospitalized due to an acute exacerbation event with elevated blood eosinophil count (≥300 cells/µL) at the index event, post-bronchodilator forced expiratory volume in 1 second/forced vital capacity ratio <0.7, and on triple therapy, or dual inhaled therapy when inhaled corticosteroids are contraindicated. Patients will be randomized to add-on dupilumab 300 mg every 2 weeks or matching placebo for 90 days.
RESULTS: There are two multiplicity-controlled primary outcomes: 1) time to first all-cause non-elective hospital readmission, emergency department visit, or death; 2) number of moderate or severe exacerbations, from the date of randomization to Day 90. Secondary outcomes include the time to first COPD-related hospital readmission, emergency department visit or death, and the time to first moderate or severe exacerbation, from baseline to Day 90. The change in Chronic Airways Assessment Test, and Exacerbations of Chronic Pulmonary Disease Tool from baseline to Weeks 3, 5, 9, and end of the trial, and the occurrence of treatment-emergent adverse events and serious adverse events from baseline through the last trial visit will also be assessed.
CONCLUSIONS: MISSION will evaluate the efficacy of dupilumab vs placebo in lowering hospital readmissions and exacerbation risk in patients with COPD and type 2 inflammation.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA80
Topic
Patient-Centered Research, Real World Data & Information Systems, Study Approaches
Disease
Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)