TRAVERSE (NCT02134028) assessed dupilumab long-term safety and efficacy in patients≥12years 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≥150cells/μL or fractional exhaled nitric oxide [FeNO]≥20 ppb) with or without an allergic phenotype (serum total IgE≥30IU/mL and≥1 perennial aeroallergen-specific IgE≥0.35kU/L) at parent study baseline and history of≥2 exacerbations in the year prior to QUEST.

In TRAVERSE, patients received dupilumab 300mg q2w for up to 96weeks (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 3years 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.