RT Journal Article
SR Electronic
T1 Late Breaking Abstract - Dupilumab long-term safety and efficacy in patients with asthma: LIBERTY ASTHMA TRAVERSE
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 4613
DO 10.1183/13993003.congress-2020.4613
VO 56
IS suppl 64
A1 Michael E. Wechsler
A1 Linda B. Ford
A1 Jorge F. Maspero
A1 Ian D. Pavord
A1 Yuji Tohda
A1 David Langton
A1 Christian Domingo
A1 Alberto Papi
A1 Arnaud Bourdin
A1 Henrik Watz
A1 Hae Sim Park
A1 Kenneth R. Chapman
A1 Xuezhou Mao
A1 Benjamin Ortiz
A1 Michel Djandji
A1 Upender Kapoor
A1 Faisal A. Khokhar
A1 Leda P. Mannent
A1 Marcella Ruddy
A1 Elizabeth Laws
A1 Nikhil Amin
A1 Megan Hardin
YR 2020
UL http://erj.ersjournals.com/content/56/suppl_64/4613.abstract
AB 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.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 4613.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).