S136 Long-term safety and efficacy of dupilumab in patients with asthma: LIBERTY ASTHMA TRAVERSE open-label extension study

Introduction and Objectives Dupilumab, a fully human monocolonal antibody, blocks the shared receptor component for interleukin (IL)–4 and IL–13, key and central drivers of type 2 inflammation in multiple diseases. The efficacy and safety up to 52 weeks of dupilumab in asthma have been demonstrated in phase 2 and phase 3 studies. We assess the long-term safety and efficacy of dupilumab in the open-label extension (OLE) LIBERTY ASTHMA TRAVERSE study (NCT02134028) in adult and adolescent patients who had completed a dupilumab asthma study (phase 2b DRI, phase 2 EXPEDITION, phase 3 QUEST, or phase 3 VENTURE). Methods Patients with moderate-to-severe or oral corticosteroid (OCS)-dependent severe asthma received add–on subcutaneous dupilumab 300 mg every 2 weeks (q2w), up to 96 weeks. Treatment-emergent adverse events (TEAEs), annualized rate of severe asthma exacerbations (AER) during the treatment period, and change from parent study baseline (PSBL) in forced expiratory volume in 1 second (FEV1) and biomarkers up to Week 96 were assessed. Results Of 2,930 patients randomized in the parent studies, 78% enrolled into the OLE; of 2,282 patients enrolled and exposed in the OLE, 96% had a study duration of 48 weeks and 54% had a study duration of 96 weeks. Long-term safety profile was consistent with the parent studies (table 1). The low unadjusted AER and improvement in FEV1 observed in the parent studies were sustained during the OLE. Similar efficacy was seen in patients with elevated type 2 biomarkers from DRI/QUEST. By Week 96, blood eosinophils decreased to below PSBL levels in patients from DRI/QUEST and were near PSBL levels in patients from VENTURE; total IgE levels decreased by 82% (median percent change from PSBL). Conclusions Long-term use of dupilumab was well tolerated and showed sustained efficacy in asthma patients up to 96 weeks.