Dupilumab vs Placebo Improves Symptoms, Asthma Control, and Asthma-Related Quality of Life in Patients With Oral Corticosteroid-Dependent Severe Asthma Through 48 Weeks of Follow up

Speaker(s)

Gurnell M1, Domingo C2, Rabe KF3, Menzies-Gow A4, Price D5, Brusselle G6, Wechsler ME7, Xia C8, Pandit-Abid N9, Gall R10, Jacob-Nara JA9, Rowe PJ9, Siddiqui S10, Deniz Y10
1University of Cambridge, Cambridge, UK, 2Corporació Sanitària Parc Taulí, Sabadell, Sabadell, Spain, 3Christian-Albrechts University (member of the German Center for Lung Research [DZL]), Kiel, Germany, 4Royal Brompton & Harefield Hospitals, London, UK, 5Observational and Pragmatic Research Institute, Singapore, Singapore, 6Ghent University, Ghent, Belgium, 7National Jewish Health, DENVER, CO, USA, 8Regeneron Pharmaceuticals, Inc., Sleepy Hollow, NY, USA, 9Sanofi, Bridgewater, NJ, USA, 10Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA

Presentation Documents

OBJECTIVES:

Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4/-13 (key and central drivers of type 2 inflammation), had an acceptable safety profile and showed clinical efficacy in patients aged ≥12 years with oral corticosteroid (OCS)–dependent severe asthma. This post hoc analysis assessed dupilumab efficacy in patients enrolled in TRAVERSE (NCT02134028), on open-label extension of VENTURE (NCT02528214).

METHODS:

Patients received add-on dupilumab 300mg every 2 weeks (q2w) or placebo for 24 weeks during VENTURE, followed by add-on dupilumab 300mg q2w for up to 96 weeks in TRAVERSE (dupilumab/dupilumab and placebo/dupilumab groups, respectively) and stratified by OCS dose (≤10 or >10mg/d) at baseline. We report annualized severe asthma exacerbation rate (AER) and changes from baseline in Asthma Control Questionnaire-5 (ACQ-5; lower score better) and Asthma Quality of Life Questionnaire (AQLQ; higher score better).

RESULTS:

187 patients (≤10mg/day — placebo/dupilumab[ n=61], dupilumab/dupilumab [n=60]; >10 mg/day — placebo/dupilumab [n=36], dupilumab/dupilumab [n=30]) are included. Mean OCS dosage declined to a greater extent with dupilumab vs placebo from baseline through TRAVERSE Week 48. Despite reduced OCS use, AER declined during VENTURE (range: 0.46–1.59) and further declined during TRAVERSE (range: 0.28–0.60), with 66.7–83.3% of patients in the dupilumab/dupilumab group experiencing no exacerbations in TRAVERSE. Mean ACQ-5 scores improved from baseline (range 2.39–2.69) to TRAVERSE Week 0 (range: 1.38–2.07), with further improvement at Weeks 24 (range: 1.29–1.61); and 48 (range: 1.24–1.59). Mean AQLQ scores improved from baseline (range: 4.19–4.43) to TRAVERSE Week 0 (range: 4.86–5.45), Week 24 (range: 5.12–5.41), and Week 48 (range: 5.11–5.51).

CONCLUSIONS:

Dupilumab improved asthma control and quality of life, regardless of baseline OCS starting dose. Improvements in AER continued during TRAVERSE and, as in VENTURE, dupilumab demonstrated persistently high reduction in OCS use without a tapering reduction schema.

Code

CO54

Topic

Clinical Outcomes

Topic Subcategory

Clinical Outcomes Assessment

Disease

STA: Biologics & Biosimilars