Long-term efficacy of dupilumab in asthma with and without chronic rhinosinusitis and/or nasal polyps

Science and Research

BACKGROUND: Coexisting chronic rhinosinusitis and/or nasal polyps (CRS/NP) substantially increases the disease burden of asthma. Dupilumab, a fully human monoclonal antibody, has established efficacy and an acceptable safety profile in asthma and CRS with NP. OBJECTIVE: This post hoc analysis assessed long-term dupilumab efficacy in TRAVERSE (NCT02134028) patients with uncontrolled, moderate-to-severe (QUEST) or oral corticosteroid (OCS)-dependent (VENTURE) asthma with/without coexisting CRS/NP. METHODS: In TRAVERSE, 317/1530 (21%) QUEST and 61/187 (48%) VENTURE patients had self-reported CRS/NP; they received subcutaneous 300 mg dupilumab every 2 weeks up to 96 weeks. Patients were categorized by parent study treatment group (placebo/dupilumab, dupilumab/dupilumab). Endpoints included annualized asthma exacerbation rates and mean change from parent study baseline (PSBL) in pre-bronchodilator forced expiratory volume in one second (FEV 1), asthma control (ACQ-5), quality of life (AQLQ), and OCS dose. RESULTS: Patients with coexisting CRS/NP had higher OCS dose and a history of more exacerbations. Concluding TRAVERSE, exacerbation rates decreased from 2.39 to 0.32 and 2.32 to 0.35 in dupilumab/dupilumab and 2.36 to 0.41 and 2.36 to 0.45 in placebo/dupilumab by Week 96 from QUEST and VENTURE baselines, respectively. Non-CRS/NP results were similar. Improvements in FEV 1, ACQ-5, and AQLQ during parent studies were maintained in TRAVERSE; placebo/dupilumab patients achieved similar improvements to dupilumab/dupilumab by Week 48. By Week 96, 71% and 39% of OCS-dependent patients with CRS/NP and 83% and 47% without CRS/NP treated with dupilumab/dupilumab and placebo/dupilumab, respectively, stopped OCS. CONCLUSION: Long-term dupilumab efficacy was maintained in patients with asthma with/without self-reported coexisting CRS/NP, including OCS-sparing effects observed in OCS-dependent severe asthma.