VENTURE (12+ years), TRAVERSE OLE (12+ years)10,12
86% of patients reduced or eliminated their OCS dose at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) vs 68% with placebo + SOC (n=107) (No biomarker requirement, ITT population, VENTURE, secondary endpoint).10
A 70% significant reduction in OCS dose (median 100%) from baseline was observed at Week 24 with DUPIXENT 300 mg Q2W + SOC (n=103) (95% CI: 60%, 80%) vs 42% (median 50%) with placebo + SOC (n=107) (VENTURE, primary endpoint).1
89% reduction in OCS dose at Week 96 (TRAVERSE OLE).13
From PSBL for patients who received DUPIXENT 300 mg Q2W + SOC in the parent study and continued on DUPIXENT during the open-label extension study (n=19).13
By Week 96 in TRAVERSE OLE, a 79% reduction in exacerbations and a 250 mL improvement in lung function from PSBL were observed.13,d-f
In addition, 79% of patients from VENTURE eliminated their OCS dose at Week 96 in TRAVERSE OLE (secondary endpoint).11
TRAVERSE OLE results are descriptive. Definitive conclusions cannot be made as this was a post hoc analysis study.
Data were not multiplicity controlled, and there are limitations associated with open-label study design, including lack of comparator arm, decreasing sample size, and potential continued involvement of responders and attrition of nonresponders.
dVENTURE: Severe exacerbations were defined as events leading to hospitalization, ED visit, or treatment for ≥3 days with OCS at ≥2 times the current dose. TRAVERSE: Severe asthma exacerbations were defined as requiring SCS for ≥3 days, hospitalization, or ED visit.11,12
eRate of unadjusted exacerbations through Week 96 in the DUPIXENT/DUPIXENT group (n=90) was 0.39 from a mean of 1.90 exacerbations in the year prior to VENTURE.11,13
f250 mL improvement in FEV1 at Week 96 of TRAVERSE from VENTURE baseline in the DUPIXENT/DUPIXENT group (n=28) vs 360 mL in the placebo/DUPIXENT group (n=32).13
gOCS reduction was at investigators’ discretion.13