)
IN NASAL CONGESTION
AS EARLY AS DAY 21,a
Patient-reported outcome. Post hoc analysis. Results are descriptive. Definitive conclusions cannot be made.1
aLSM difference between DUPIXENT 300 mg Q2W + INCS (n=438) and placebo + INCS (n=286): -0.07 (95% CI: -0.13, -0.01).1,2
in NC score through
Week 523,b,c
Analysis at Week 24 (Q2W only) was not multiplicity controlled. Results are descriptive. Definitive conclusions cannot be made.3
bNC score at Week 24 in SINUS-52 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -0.87 (95% CI: -1.03, -0.71) (-1.25 from a baseline score of 2.46 vs -0.38 from a baseline score of 2.38, respectively) (P<0.0001).3,4
cNC score at Week 52 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -0.98 (95% CI: -1.17, -0.79) (-1.35 from a baseline score of 2.48 vs -0.37 from a baseline score of 2.38, respectively) (P<0.0001).3,4
dNC score at Week 24 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -0.79 (95% CI: -0.98, -0.61) (-1.17 from a baseline score of 2.48 vs -0.38 from a baseline score of 2.38, respectively).3
Nasal congestion (NC) score (range 0-3); reduced score indicates improvement.4
INCS, intranasal corticosteroids; LSM, least squares mean; Q2W, once every 2 weeks.
CRSwNP, chronic rhinosinusitis with nasal polyps.
Use of DUPIXENT for the CRSwNP indication in patients aged 12-17 years is supported by evidence from studies of DUPIXENT as add-on maintenance
treatment in adults with inadequately controlled CRSwNP.4
Illustrations of endoscopy adapted from actual patient images. Individual results may vary.
Reduction in bilateral NPS as early as Week 4,g sustained through Week 523,e,f
Analysis at Week 4 was not multiplicity controlled. Results are descriptive. Definitive conclusions cannot be made.3
eNPS at Week 52 in SINUS-52 (key secondary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -2.40 (95% CI: -2.77, -2.02) (-2.24 from a baseline score of 6.07 vs 0.15 from a baseline score of 5.96, respectively) (P<0.0001).3,4
fNPS at Week 24 in SINUS-52 (coprimary endpoint). LSM difference between DUPIXENT 300 mg Q2W + INCS (n=295, pooled arms) and placebo + INCS (n=153): -1.80 (95% CI: -2.10, -1.51) (-1.71 from a baseline score of 6.18 vs 0.10 from a baseline score of 5.96, respectively) (P<0.0001).3,4
gNPS at Week 4 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -1.18 (95% CI: -1.47, -0.90) (-1.13 from a baseline score of 6.07 vs 0.05 from a baseline score of 5.96, respectively).3
hNPS at Week 24 in SINUS-52. LSM difference between DUPIXENT 300 mg Q2W + INCS (n=150) and placebo + INCS (n=153): -1.79 (95% CI: -2.13, -1.44) (-1.69 from a baseline score of 6.07 vs 0.09 from a baseline score of 5.96, respectively).3
Nasal polyp score (NPS), the sum of right and left nostril scores (range 0-4 for each nostril, range 0-8 in total) as evaluated by nasal endoscopy: reduced score indicates improvement.4
INCS, intranasal corticosteroids; LSM, least squares mean; Q2W, once every 2 weeks.
DUPIXENT DISTINCTLY SHOWED IMPROVEMENT IN LUNG FUNCTION IN PATIENTS WITH CRSwNP AND COEXISTING ASTHMA5,6,i,j,*
in pre-bronchodilator FEV1 at Week 24 between DUPIXENT 300 mg Q2W + INCS (n=176) and placebo + INCS (n=124) (95% CI: 110, 310 mL)5,6
*Patients with baseline blood EOS levels ≥300 cells/μL.5,6
Post hoc analysis was not multiplicity controlled. Results are descriptive. Definitive conclusions cannot be made.5,6
According to the DUPIXENT Prescribing Information, in subjects with CRSwNP and coexisting asthma, improvements in pre-bronchodilator FEV1 were similar to those of subjects in the DUPIXENT asthma program.4
DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
iPatients with coexisting asthma enrolled in the CRSwNP clinical trials had a mean FEV1 84% predicted at baseline. Patients with FEV1 ≤50% predicted were excluded. Patients were not selected based on minimum biomarker or asthma severity requirements.3,5,6
jA majority of patients in the CRSwNP trials were on oral steroids to treat CRSwNP, which may affect baseline EOS levels.3,5,7
INCS, intranasal corticosteroids; LSM, least squares mean; Q2W, once every 2 weeks.
CRSwNP, chronic rhinosinusitis with nasal polyps; EOS, eosinophil; FEV1, forced expiratory volume in 1 second.
Use of DUPIXENT for the CRSwNP indication in patients aged 12-17 years is supported by evidence from studies of DUPIXENT as add-on maintenance
treatment in adults with inadequately controlled CRSwNP.4