B32-26 Long-term Efficacy of Dupilumab in Patients With Asthma and Ongoing Coexisting Type 2 Inflammatory Conditions

Abstract Rationale The presence of coexisting type 2 conditions in patients with asthma increases treatment difficulty. The efficacy of dupilumab in patients with moderate-to-severe asthma was demonstrated in the phase 3 QUEST (NCT02414854) and long-term extension TRAVERSE (NCT02134028) trials. Here, we report the long-term efficacy of dupilumab in patients with type 2 asthma (blood eosinophils ≥150 cells/µL or fractional exhaled nitric oxide ≥25 ppb) and an ongoing coexisting condition: allergic rhinitis (AR; n = 859), atopic dermatitis (AD; n = 142), or chronic rhinosinusitis with nasal polyposis or nasal polyposis (CRSwNP/NP; n = 329). Methods Patients received add-on dupilumab 200/300 mg every 2 weeks (q2w) or placebo for 52 weeks in QUEST and then dupilumab 300 mg q2w for up to 96 weeks in TRAVERSE (placebo-dupilumab and dupilumab-dupilumab groups). Unadjusted annualized severe exacerbation rates and mean (SD) change from QUEST baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) and 5-item Asthma Control Questionnaire (ACQ-5) score over time were assessed. Results In QUEST, dupilumab vs placebo reduced exacerbation rates in patients with coexisting AR (0.526 vs 1.104), AD (0.659 vs 1.009), and CRSwNP/NP (0.563 vs 1.515). In TRAVERSE, patients in the placebo-dupilumab groupexperienced markedly reduced exacerbation rates (AR: 0.333; AD: 0.309; CRSwNP/NP: 0.356) and patients in the dupilumab-dupilumab group showed further reduced exacerbation rates (AR: 0.322; AD: 0.433; CRSwNP/NP: 0.333). Dupilumab vs placebo improved pre-bronchodilator FEV1 (L) at QUEST Week 52 in patients with AR (0.36 0.47 vs 0.17 0.42), AD (0.41 0.48 vs 0.27 0.43), and CRSwNP/NP (0.42 0.49 vs 0.14 0.40). At Week 48 in TRAVERSE, dupilumab treatment improved pre-bronchodilator FEV1 in the placebo-dupilumab group (AR: 0.38 0.43; AD: 0.41 0.46; CRSwNP/NP: 0.40 0.42) and sustained QUEST pre-bronchodilator FEV1 improvements in the dupilumab-dupilumab group (AR: 0.40 0.54; AD: 0.42 0.52; CRSwNP/NP: 0.43 0.47. Dupilumab vs placebo reduced ACQ-5 scores at QUEST Week 52 in patients with AR (−1.54 1.08 vs − 1.17 1.01), AD (−1.55 0.91 vs − 1.31 1.03), and CRSwNP/NP (−1.71 1.10 vs − 1.14 1.01). At TRAVERSE Week 48, asthma control improved in the placebo-dupilumab (AR: −1.66 1.09; AD: −1.62 1.24; CRSwNP/NP: −1.78 1.09) and dupilumab-dupilumab groups (AR: −1.76 1.07; AD: −1.81 1.03; CRSwNP/NP: −1.99 0.99). Conclusion Dupilumab reduced exacerbation rates and improved lung function and asthma control for up to 2 years in patients with type 2 asthma, despite the patients having coexisting type 2 inflammatory conditions. This abstract is funded by: Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02414854 and NCT02134028