Assessment of the long-term safety and efficacy of dupilumab in children with asthma: LIBERTY ASTHMA EXCURSION

Abstract

<b>Introduction:</b> 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. <b>Aim:</b> 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). <b>Methods:</b> 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. <b>Results:</b> 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). <b>Conclusion:</b> 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.