Author(s)
Busse WW1, Pavord ID2, Corren J3, Menzies-Gow A4, Heffler EG5, Msihid J6, Siddiqui S7, Lederer DJ7, Hardin M8, Zhang Y7, Khan AH6, Jacob-Nara JA9, Deniz Y7, Rowe PJ9
1UW Allergy, Pulmonary and Critical Care Medicine University of Wisconsin, Madison, WI, USA, 2NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK, 3David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA, 4Royal Brompton & Harefield NHS Foundation Trust, London, UK, 5Humanitas University, IRCCS Humanitas Research Hospital, Milan, Italy, 6Sanofi, Chilly-Mazarin, France, 7Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 8Sanofi, Cambridge, MA, USA, 9Sanofi, Bridgewater, NJ, USA
Background: The TRAVERSE open-label extension study (NCT02134028) assessed long-term safety and efficacy of dupilumab in patients aged ≥12 years with moderate-to-severe asthma who had completed a parent dupilumab asthma study. This post-hoc analysis assessed the long-term effect (up to 48 weeks) of dupilumab on asthma control in patients with uncontrolled, moderate-to-severe, type 2 asthma (blood eosinophils ≥150 cells/μL or FeNO ≥25 ppb) at parent study baseline (PSBL) who enrolled in TRAVERSE from phase 3 QUEST (NCT02414854) and the number of sick leave days due to severe exacerbations. Methods: Asthma control using the 5-item Asthma Control Questionnaire (ACQ-5) and the unadjusted annualized number of sick leave days due to severe exacerbations over the TRAVERSE treatment period were evaluated. Results: Overall, 804 patients received dupilumab in QUEST and TRAVERSE (dupilumab/dupilumab); 423 patients received placebo in QUEST, followed by dupilumab in TRAVERSE (placebo/dupilumab). At PSBL, <1% of patients had well-controlled (ACQ-5 score ≤0.75) or controlled (ACQ-5 <1.5) asthma. During TRAVERSE, a higher percentage of patients in the dupilumab/dupilumab arm than in the placebo/dupilumab arm had well-controlled (Week 0: 41% and 24%; Week 24: 46% and 38%) or controlled (Week 0: 68% and 55%; Week 24: 74% and 71%) asthma. Asthma control improved in patients who switched to dupilumab in TRAVERSE from placebo. At TRAVERSE Week 48, proportions of patients achieving well-controlled and controlled asthma in dupilumab/dupilumab and placebo/dupilumab arms were comparable (46% and 42% and 76% and 74%, respectively). Employed patients in dupilumab/dupilumab group reported 0.660 sick leave days/year (unadjusted annualized rate) due to exacerbation and 0.914 sick leave days/year in placebo/dupilumab group. Conclusion: Dupilumab was associated with sustained improvements in asthma control over the 48-week treatment period in patients with moderate-to-severe type 2 asthma and <1 sick day/year due to severe asthma exacerbations in employed patients in the overall exposed TRAVERSE population.
Conference/Value in Health Info
2022-05, ISPOR 2022, Washington, DC, USA
Value in Health, Volume 25, Issue 6, S1 (June 2022)
Code
PCR69
Topic
Patient-Centered Research, Study Approaches
Topic Subcategory
Clinical Trials, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas