Long-Term Dupilumab Treatment Effect On Safety And Clinical Efficacy In Children With Type 2 Asthma: LIBERTY ASTHMA EXCURSION

Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL-4/IL-13. Efficacy and safety of dupilumab in 6–11-year-old children with uncontrolled, moderate-to-severe asthma were demonstrated in VOYAGE (NCT02948959). The EXCURSION open-label extension study (NCT03560466) assessed dupilumab long-term safety and efficacy in children who completed VOYAGE. 365 patients rolled over from VOYAGE into EXCURSION and received add-on subcutaneous dupilumab 100/200mg q2w or 300mg q4w (body-weight based) for 52 weeks. Treatment-emergent adverse events (TEAE), annualized exacerbation rates (AER), and change from parent study baseline (PSBL) in percent predicted (pp)FEV1, ppFVC and FEV1/FVC were assessed. 85 (68.0%; placebo/dupilumab) and 147 (61.3%; dupilumab/dupilumab) of all patients in EXCURSION experienced TEAEs, with 3 (1.3%) in the dupilumab/dupilumab group leading to treatment discontinuation. Unadjusted AER for patients with type 2 asthma (baseline blood eosinophils ≥150cells/μL or FeNO ≥20ppb) was 0.124 for placebo/dupilumab and 0.118 for dupilumab/dupilumab. Mean PSBL ppFEV1 was 78.7% (placebo/dupilumab) and 76.9% (dupilumab/dupilumab), with mean change from PSBL at EXCURSION Weeks 2/52 of +8.7/+9.4 (placebo/dupilumab), and +11.3/+12.6 (dupilumab/dupilumab). Mean PSBL ppFVC was 92.7% (placebo/dupilumab) and 91.9% (dupilumab/dupilumab), with mean change from PSBL at EXCURSION Weeks 2/52 of +3.7/+4.4 (placebo/dupilumab), and +5.4/+6.9 (dupilumab/dupilumab). Mean PSBL FEV1/FVC was 74.2% (placebo/dupilumab) and 73.4% (dupilumab/dupilumab), with mean change from PSBL at EXCURSION Weeks 2/52 of +4.6/+4.5 (placebo/dupilumab) and +5.6/+5.4 (dupilumab/dupilumab). Dupilumab long-term use was well tolerated. The efficacy observed with dupilumab treatment in the VOYAGE study was sustained. Rapid lung function improvement was observed in patients who switched from placebo to dupilumab.