Long-term efficacy and safety of dupilumab in patients enrolled from Latin American centers from the open-label extension LIBERTY ASTHMA TRAVERSE study.

Abstract

Objective: Uncontrolled asthma is common among Latin American patients. Dupilumab, a human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, drivers of type 2 inflammation.

Methods: This post hoc analysis of 48-96 week open-label extension TRAVERSE (NCT0213402) study assessed dupilumab 300 mg every 2 wk up to 148 wk (parent study plus extension) in patients with moderate-to-severe asthma enrolled from Latin American centers who previously completed a dupilumab asthma study (phase 2b or phase 3 QUEST). Endpoints included treatment-emergent adverse events, severe asthma exacerbations, pre-bronchodilator forced expiratory volume in 1 s (FEV₁), 5-Item Asthma Control Questionnaire (ACQ-5), Asthma Quality of Life Questionnaire (AQLQ), and type 2 biomarkers.

Results: A total of 596 (28.9%) patients were enrolled from Latin American centers. Safety was consistent with the known dupilumab safety profile. Annualized rate of severe exacerbations remained low across patients (0.115-0.459). Improvements in pre-bronchodilator FEV₁ were sustained to Week 96 (mean change from parent study baseline of 0.28-0.35 L) and in ACQ-5 and AQLQ scores to Week 48 (last assessed time-point). Patients receiving placebo during parent studies demonstrated improvements once switched to dupilumab in TRAVERSE. Patients receiving dupilumab during parent studies demonstrated further improvements in exacerbations, ACQ-5, and AQLQ. Type 2 biomarkers decreased over time.

Conclusions: Consistent with results in the overall population, long-term efficacy and safety of dupilumab was observed in patients with moderate-to-severe asthma with a treatment duration of up to 148 wk, supporting the long-term benefits of dupilumab use in Latin American patients.