Dupilumab efficacy in patients with GINA-defined type 2 asthma: TRAVERSE

Abstract

<b>Background:</b> GINA 2020 report recommends add-on biologics for patients (pts) with type 2 (T2) asthma (≥150 blood eosinophils/µL or FeNO ≥20ppb, largely allergen-driven disease). Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL-4/13, key and central drivers of T2 inflammation. In QUEST (NCT02414854), add-on DPL 200/300mg every 2 weeks vs placebo (PBO) reduced exacerbations and improved FEV₁ in pts with uncontrolled, moderate-to-severe asthma. TRAVERSE, a single-arm, open-label extension study (NCT02134028), evaluated DPL long-term safety and efficacy in pts from QUEST. <b>Aim:</b> To assess DPL long-term efficacy in pts according to baseline T2 biomarkers and allergic status as suggested by GINA. <b>Methods:</b> Pts who received DPL or PBO in QUEST received DPL 300mg in TRAVERSE for up to 96 weeks. We evaluated annualized severe exacerbation rate (AER) and pre-BD FEV₁ in T2 pts with/without evidence of allergic asthma phenotype (serum total IgE ≥30 IU/mL and ≥1 perennial aeroallergen-specific IgE ≥0.35kU/L at parent study baseline). <b>Results:</b> DPL reduced AERs and improved pre-BD FEV₁ in pts with elevated eosinophils or FeNO. These effects were sustained throughout TRAVERSE (Table). Allergic phenotype did not influence DPL efficacy. <b>Conclusion:</b> DPL reduced severe exacerbations and improved FEV₁ for up to 96 weeks in patients with T2 inflammatory asthma as specified in recent GINA recommendations, irrespective of allergic phenotype.