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Asthma exacerbations are subject to seasonal variability. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation in multiple diseases. The TRAVERSE open-label extension study (NCT02134028) evaluated long-term safety and tolerability of add-on dupilumab in patients with uncontrolled, moderate-to-severe asthma from the 52-week QUEST study (NCT02414854). This post-hoc analysis assessed long-term dupilumab efficacy in reducing seasonal asthma exacerbations in patients with/without evidence of an allergic phenotype. QUEST patients with type 2 inflammatory asthma (blood eosinophils ≥ 150 cells/μL or FeNO ≥ 25 ppb) at baseline, with/without evidence of allergic phenotype (baseline serum IgE ≥ 30 IU/mL and ≥ 1 perennial aeroallergen-specific IgE ≥ 0.35 kU/L), received 200/300 mg dupilumab or placebo every 2 weeks (q2w) for 52 weeks, then 300 mg dupilumab q2w for up to 96 weeks during TRAVERSE. Percentage of patients experiencing ≥ 1 severe seasonal exacerbation during both studies was evaluated. Patients receiving placebo and dupilumab during QUEST are referred to as placebo/dupilumab and dupilumab/dupilumab, respectively. The percentage of patients with an allergic phenotype experiencing exacerbations per season during QUEST was 17.3–24.2% (placebo) vs. 12.6–13.0% (dupilumab), and 19.3–29.5% (placebo) vs. 7.6–12.0% (dupilumab) in patients without an allergic phenotype. Dupilumab further reduced exacerbations per season during TRAVERSE (patients with allergic phenotype: 4.6–9.6% [placebo/dupilumab] and 8.0–5.5% [dupilumab/dupilumab]; patients without allergic phenotype: 5.8–8.1% [placebo/dupilumab] and 4.8–8.2% [dupilumab/dupilumab]). Dupilumab reduced seasonal exacerbations during QUEST in patients with/without evidence of an allergic phenotype, which was sustained during TRAVERSE. [ABSTRACT FROM AUTHOR]

TRAVERSE (NCT02134028) assessed dupilumab long-term safety and efficacy in patients ≥ 12 years who previously completed a dupilumab asthma study. Safety was consistent with the known dupilumab safety profile. To evaluate dupilumab long-term efficacy in patients included in TRAVERSE who previously participated in QUEST (NCT02414854) and had type 2 asthma (blood eosinophils ≥ 150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥ 20 ppb) with or without an allergic phenotype (serum total IgE ≥ 30 IU/mL and ≥ 1 perennial aeroallergen-specific IgE ≥ 0.35 kU/L) at parent study baseline and history of ≥ 2 exacerbations in the year prior to QUEST. In TRAVERSE, patients received dupilumab 300 mg q2w for up to 96 weeks (dupilumab/dupilumab and placebo/dupilumab groups). Unadjusted annualized severe asthma exacerbation rate (AER) and change from QUEST baseline FEV1 were assessed. In Year 1 of treatment (QUEST), dupilumab vs. placebo reduced AER to 0.578/1.490 and 0.470/1.476 in patients with and without an allergic phenotype, respectively. In Year 2 (TRAVERSE Weeks 0–48), AER was further reduced to 0.474/0.591 and 0.320/0.295 in dupilumab/dupilumab- vs. placebo/dupilumab-treated patients with and without an allergic phenotype, respectively; in Year 3 (TRAVERSE Weeks 48–96), AER was 0.353/0.203 and 0.214/0.268, respectively. In the dupilumab/dupilumab group, improvements in FEV1 from baseline seen during QUEST were sustained through VENTURE. Lung function improved rapidly in the placebo/dupilumab group after initiating dupilumab in TRAVERSE and these improvements were sustained through the study. Patterns of improvements in lung function were similar in patients with and without an allergic phenotype. Dupilumab sustained reductions in exacerbations and improvements in FEV1 for up to 3 years in patients with uncontrolled, moderate-to-severe type 2 asthma with a history of ≥ 2 exacerbations prior to study start, regardless of evidence of allergic asthma. [ABSTRACT FROM AUTHOR]