S84 Long-term efficacy of dupilumab: 3-year data of QUEST patients with moderate-to-severe asthma enrolled in LIBERTY ASTHMA TRAVERSE

Abstract

<h3>Introduction and Objectives</h3> 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, including asthma. In the phase 3 LIBERTY ASTHMA QUEST study (NCT02414854), add-on dupilumab 200/300 mg every 2 weeks (q2w) significantly reduced severe asthma exacerbations and improved pre-bronchodilator forced expiratory volume in 1 second (FEV₁) vs matched placebo in patients with uncontrolled, moderate-to-severe asthma. The LIBERTY ASTHMA TRAVERSE open-label extension study (NCT02134028) evaluated the long-term safety, tolerability, and efficacy of dupilumab in patients who had completed a previous dupilumab asthma study. This post hoc analysis evaluated the efficacy of dupilumab in patients from QUEST who rolled over into TRAVERSE and received a further 96 weeks of dupilumab treatment. <h3>Methods</h3> We evaluated data from QUEST patients treated with dupilumab q2w or matched placebo for 52 weeks who rolled over into TRAVERSE and received 96 weeks of dupilumab 300 mg q2w. We assessed the unadjusted annualized rate of severe asthma exacerbations (AER) during QUEST (Weeks 0–52) and TRAVERSE (Weeks 0–48 and Weeks 48–96) and the mean change from QUEST baseline in pre-bronchodilator FEV₁ in QUEST over the QUEST and TRAVERSE studies. <h3>Results</h3> The unadjusted AER in dupilumab-treated patients was low during QUEST, with progressive reductions observed during the treatment period of 96 weeks in TRAVERSE and a majority of patients experiencing no exacerbations (figure 1A). In the placebo/dupilumab group of patients, the unadjusted AER decreased significantly during TRAVERSE compared with QUEST and was similar to the AER in dupilumab/dupilumab patients. Clinically meaningful improvements in pre-bronchodilator FEV₁ were observed at Week 52 of QUEST in dupilumab/dupilumab patients, which were sustained with no apparent loss of treatment effect at Weeks 48 and 96 of TRAVERSE (figure 1B). Large improvements in pre-bronchodilator FEV₁ were observed in placebo/dupilumab patients upon initiation of dupilumab, which were sustained throughout the TRAVERSE treatment period. <h3>Conclusions</h3> Dupilumab demonstrated sustained efficacy in reducing severe asthma exacerbations and improving lung function in patients with moderate-to-severe asthma who completed 96 weeks of treatment. Please refer to page A189 for declarations of interest related to this abstract.