Abstract
Introduction: Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL‑4/13. The efficacy and safety of DPL in children with asthma have been demonstrated up to 52 weeks (wks) in the VOYAGE study.
Aim: This open-label extension (OLE) study (NCT03560466) assessed DPL long-term safety and efficacy in children with uncontrolled, moderate to severe asthma who completed VOYAGE (aged 6-11 years at enrolment in the parent study).
Methods: 365 patients (pts) rolled over from VOYAGE into EXCURSION, and received add‑on SC DPL 100/200mg (body-weight based) every 2 wks for 52 wks. A subgroup of pts received 300mg every 4 wks. Treatment-emergent adverse events (TEAE), annualized rate of severe asthma exacerbations (AER), and change from parent study baseline (PSBL) in percent predicted (pp) FEV1 were assessed.
Results: Safety during the OLE was consistent with the parent study. The low unadjusted AER/improvement in ppFEV1 observed with DPL in the parent study were sustained in the OLE in type 2 pts (with blood eosinophils ≥150 ells/µL or ≥20ppb FeNO at PSBL). Pts who switched from PBO to DPL also showed low AER, and ppFEV1 improvement as early as Wk 2 (Table).
Conclusion: Long-term use of DPL was well tolerated. The efficacy observed in the parent study was sustained over an additional 52 wks in pts with type 2 asthma, with rapid lung function improvement in pts who switched from PBO to DPL.
Footnotes
Cite this article as Eur Respir J 2022; 60: Suppl. 66, 4570.
This article was presented at the 2022 ERS International Congress, in session “-”.
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).
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