Improvement in Lung Function vs Placebo Was Seen at Week 24 in a Prespecified Pooled Analysis of SINUS-24 and SINUS-52 (Secondary Endpoint)1,a
AT WEEK 24
from baseline in pre-bronchodilator FEV1 with DUPIXENT 300 mg Q2W + INCS (n=258) vs -70 mL with placebo + INCS (n=170) (LSM difference: 210 mL [95% CI: 130, 290 mL])1
Patients with comorbid asthma enrolled in DUPIXENT CRSwNP clinical trials had a mean percent predicted FEV1 of 84%, and any patients with FEV1 ≤50% of predicted normal were excluded2-4
~60% of patients enrolled in the CRSwNP trials had comorbid asthma.
Improvements in pre‑bronchodilator FEV1 were similar to those in the
DUPIXENT asthma program5
aA majority of patients in the CRSwNP trials were on oral steroids to treat CRSwNP, which may affect baseline EOS levels.6
Change in Lung Function at Week 12 in the ITT Population in the Asthma Clinical Trial
Program (Asthma SINUS-52, Primary Endpoint)5,b
- 340 mL IMPROVEMENT FROM BASELINE IN PRE-BRONCHODILATOR FEV1 with DUPIXENT 300 mg Q2W + SOC (n=633)
vs 210 mL improvement with placebo + SOC (n=321) (LSM difference: 130 mL [95% CI: 80, 180 mL])
- In Asthma SINUS-52, a significant difference from placebo + SOC was not observed at 12 weeks in change in pre-bronchodilator FEV1 in patients with baseline blood EOS levels ≥150 to <300 cells/μL taking DUPIXENT 300 mg Q2W + SOC and in patients with baseline blood EOS levels <150 cells/μL taking DUPIXENT 300 mg Q2W + SOC
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.
Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
bITT population was unrestricted by minimum baseline blood EOS count.5
Asthma Control, as
Measured by ACQ-6
Greater improvements vs placebo
were seen at Week 24 and Week 52
(post hoc analysis)1,c
from baseline in ACQ-6 score (SINUS-52: additional endpoint) with DUPIXENT 300 mg Q2W + INCS (n=176, pooled DUPIXENT arms) (-0.78 from a baseline score of 1.55) vs 5% worsening with placebo + INCS (n=91) (0.08 from a baseline score of 1.63) (LSM difference: -0.87 [95% CI: -1.07, -0.66])2
from baseline in ACQ-6 score (SINUS-52: additional endpoint) with DUPIXENT 300 mg Q2W + INCS (n=85) (-0.83 from a baseline score of 1.45) vs 7% worsening with placebo + INCS (n=91) (0.12 from a baseline score of 1.63) (LSM difference: -0.94
[95% CI: -1.19, -0.69])2
cThe analysis of this endpoint was not multiplicity controlled. Results are descriptive.
AS SINUS-525: 52-WEEK STUDY–1902
adolescents (12-17 years) and adults (≥18 years) with moderate-to-severe asthma on a standard of care of medium- or high-dose ICS and a minimum of 1 and up to 2 additional controller medications were randomized into 2 groups: DUPIXENT 200 mg Q2Wd + SOC (n=631) or placebo + SOC (n=317); or DUPIXENT 300 mg Q2We + SOC (n=633) or placebo + SOC (n=321). Subjects enrolled in SINUS-52 were required to have a history of 1 or more asthma exacerbations that required treatment with systemic corticosteroids or emergency department visit or hospitalization for the treatment of asthma in the year prior to trial entry. Subjects with baseline blood EOS levels >1500 cells/µL (<1.3%) were excluded. DUPIXENT was administered as an add-on to background asthma treatment. Two primary endpoints: Mean change from baseline to Week 12 in FEV1 in the overall population and annualized rate of severe exacerbation events during the 52-week treatment period in the overall population. Secondary endpoint: Mean change from baseline to Week 52 in FEV1 in patients with baseline eosinophils ≥300 cells/μL. Selected baseline demographics: Mean age: 48 years; female: 63%; white: 83%; mean duration of asthma: 21 years; mean exacerbations in previous year: 2.1; high-dose ICS use: 52%; pre-dose FEV1 at
baseline: 1.78 L; mean FeNO: 35 ppb; mean total IgE: 432 IU/mL; and mean baseline blood EOS count: 360 cells/µL.
The Asthma Control Questionnaire, 6-item version (ACQ-6), is a patient-reported measure of asthma control. A higher score indicates less asthma control. A global score is calculated ranging from 0 to 6. The meaningful clinically important difference is 0.5.5
dWith 400 mg loading dose.
eWith 600 mg loading dose.
EOS, eosinophil; FeNO, fractional exhaled nitric oxide; ITT, intention-to-treat.