VOYAGE and EXCURSION OLE (6-11 years)¹⁴

DUPIXENT has efficacy and safety results in children aged 6-11 years with moderate-to-severe asthma through Year 2.^6,14

Lung function results⁶

~2X improvement was seen with DUPIXENT at Week 12 in percent predicted pre-bronchodilator FEV₁ vs placebo (VOYAGE, key secondary endpoint).

• 5.21% improvement in percent predicted pre-bronchodilator FEV₁ in children aged 6-11 years with EOS ≥150 cells/μL or FeNO ≥20 ppb at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=229) vs placebo + SOC (n=110)
• 5.32% improvement in percent predicted pre-bronchodilator FEV₁ in children aged 6-11 years with EOS ≥300 cells/μL at Week 12 with DUPIXENT 100 mg/200 mg Q2W + SOC (n=168) vs placebo + SOC (n=80)

Long-term lung function results were observed in children who continued with DUPIXENT from the parent study (VOYAGE) through Week 52 in EXCURSION OLE (n=209).¹⁴

• By Week 52 in EXCURSION OLE, percent predicted pre-bronchodilator FEV₁ improvement results from baseline were 12.6% in the DUPIXENT/DUPIXENT group (n=209) and 9.4% in the placebo/DUPIXENT group (n=106) (secondary endpoint)
• By Week 52 in EXCURSION OLE, 78% of children in the DUPIXENT/​DUPIXENT group (n=184) had percent predicted pre-bronchodilator FEV₁ ≥80%^h

Exacerbation reduction results⁶

DUPIXENT significantly reduced exacerbations in children aged 6-11 years through Year 1 (VOYAGE, primary endpoint).

• 59% reduction in annualized severe exacerbations in children aged 6-11 years with EOS ≥150 cells/µL or FeNO ≥20 ppb at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (0.31) vs placebo + SOC (0.75), rate ratio: 0.41 (95% CI: 0.27, 0.61); P<0.001
• 65% reduction in annualized severe exacerbations in children aged 6-11 years with EOS ≥300 cells/µL at Week 52 with DUPIXENT 100 mg/200 mg Q2W + SOC (0.24) vs placebo + SOC (0.67), rate ratio: 0.35 (95% CI: 0.21, 0.56); P<0.001

Reductions in exacerbations were observed from the parent study (VOYAGE) in children who continued with DUPIXENT treatment through Week 52 in EXCURSION OLE (n=209) and in children on placebo in VOYAGE who switched to DUPIXENT in EXCURSION OLE (n=106).¹⁴

• A 95% reduction was observed in the unadjusted annualized severe exacerbation rate in patients who enrolled in EXCURSION OLE (DUPIXENT/DUPIXENT group [rate: 0.118; n=209]) from PSBL through Year 2 in patients with moderate-to-severe asthma (EOS count ≥150 cells/μL or FeNO ≥20 ppb) (PSBL rate: 2.56) (secondary endpoint)ⁱ
• A 94% reduction was observed in unadjusted annualized severe exacerbation rate in patients who enrolled in EXCURSION OLE (placebo/DUPIXENT group [rate: 0.124; n=106]) from PSBL through Year 2 in patients with moderate-to-severe asthma (EOS count ≥150 cells/μL or FeNO ≥20 ppb) (PSBL rate: 2.16) (secondary endpoint)ⁱ
• Zero exacerbations were observed in 91% of children aged 6-11 through Year 2 in EXCURSION OLE^j

Long-term safety data¹⁴

The long-term safety profile in EXCURSION OLE was similar to that observed in the VOYAGE parent study.

EXCURSION OLE results are descriptive. Definitive conclusions cannot be made.

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.