LONG-TERM DUPILUMAB REDUCES EXACERBATIONS AND IMPROVES LUNG FUNCTION IN TYPE 2 PATIENTS WITH/WITHOUT ALLERGIC

Abstract

<h3>Introduction</h3> 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. This analysis of TRAVERSE evaluated dupilumab long-term efficacy in patients who previously participated in QUEST (NCT02414854) and had type 2 asthma (blood eosinophils ≥150cells/µL or fractional exhaled nitric oxide [FeNO] ≥20ppb) 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. <h3>Methods</h3> In TRAVERSE, patients received dupilumab 300mg 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. <h3>Results</h3> 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. Dupilumab sustained FEV₁ improvements in the dupilumab/dupilumab group and rapidly improved lung function in the placebo/dupilumab group after initiating dupilumab in TRAVERSE (<b>Figure</b>). <h3>Conclusions</h3> 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.