LONG-TERM SAFETY AND EFFICACY OF DUPILUMAB IN CHILDREN WITH ASTHMA: LIBERTY ASTHMA EXCURSION

Abstract

<h3>Introduction</h3> Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL-4/IL-13. Efficacy and safety of dupilumab in children with asthma have been demonstrated up to 52 weeks in VOYAGE (NCT02948959). <h3>Methods</h3> 365 pediatric participants who completed VOYAGE entered EXCURSION (NCT03560466), a 52-week open-label study of dupilumab 100/200mg (body-weight based) every 2 weeks; a patient subgroup received 300mg every 4 weeks. Treatment-emergent adverse events, blood eosinophil count, total serum IgE, annualized rate of severe asthma exacerbations (AER), and change from VOYAGE baseline in percent predicted forced expiratory volume in 1 second (ppFEV₁) were assessed. <h3>Results</h3> Dupilumab was well tolerated, and the safety profile was consistent with the parent study (<b>Table</b>). Blood eosinophil count decreased from baseline in VOYAGE with median changes (Q1:Q3) of -140 (-410:10) cells/µL at EXCURSION Week 52 for dupilumab/dupilumab (n=191) and -30 (-260:70) cells/µL for placebo/dupilumab (n=105). Total IgE declined substantially throughout EXCURSION with median percent change from VOYAGE baseline to EXCURSION Week 52 of -89.9% for dupilumab/dupilumab (-339.0 IU/mL; n=219) and -80.0% for placebo/dupilumab (-278.0 IU/mL; n=114). Median total IgE at Week 52 was 40.5 and 53.5 IU/mL for dupilumab/dupilumab and placebo/dupilumab, respectively. The low unadjusted AER and improved ppFEV₁ observed in VOYAGE were sustained in patients with type 2 inflammatory phenotype (<b>Table</b>). <h3>Conclusion</h3> Long-term use of dupilumab was well tolerated, with a decline in type 2 biomarkers including blood eosinophils and total serum IgE. Efficacy observed in VOYAGE in patients with type 2 asthma was sustained in EXCURSION over an additional 52 weeks.