Late Breaking Abstract - Dupilumab long-term safety and efficacy in patients with asthma: LIBERTY ASTHMA TRAVERSE

Abstract

Introduction: Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL‑4/IL‑13. The efficacy and safety of DPL in asthma have been demonstrated up to 52 wks in phase (P) 2/3 studies. Aim: This open-label extension (OLE) study (NCT02134028) assessed long-term safety and efficacy of DPL in adult and adolescent patients (pts) who had completed a DPL asthma study (P2b DRI, P2 EXPEDITION, P3 QUEST or VENTURE). Methods: 2282 moderate-to-severe asthma or OCS-dependent severe asthma pts received add‑on SC DPL 300mg every 2 wks up to 96 wks. Treatment-emergent adverse events (TEAE), annualized rate of severe asthma exacerbations (AER) during the treatment period, and change from parent study baseline (BL) in FEV1 and biomarkers up to Wk 96 were assessed. Results: 2039 pts completed the OLE treatment period with a safety profile that was consistent with the shorter-duration parent studies (Table). The low unadjusted AER and improvement in FEV1 observed in the parent studies were sustained during the OLE. Similar efficacy was seen in pts with elevated type 2 biomarkers from DRI/QUEST. By Wk 96, blood eosinophils decreased to below-parent study BL levels in pts from DRI/QUEST and were near-parent study BL levels in pts from VENTURE; total IgE levels decreased by 82% (median % change from parent BL). Conclusion: Long-term use of dupilumab was well tolerated and showed sustained efficacy in asthma pts up to 96 wks.