DUPIXENT +
SOC
200 mg Q2Wa (n=150)
Placebo + SOC (n=158)
DUPIXENT + SOC
300 mg Q2Wb (n=157)
Placebo + SOC (n=158)
Adults (≥18 years) with
moderate-to-severe asthma
on a standard of care of
medium- or high-dose ICS
and a long-acting beta agonist
Subjects enrolled in DRI12544 were required to have, within 1 year of trial enrollment, treatment with systemic corticosteroids for worsening asthma at least once, or ED visit or hospitalization for worsening asthma
Subjects continued background asthma therapy throughout the duration of the studies, except in VENTURE in which OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained
Mean change from baseline to Week 12 in FEV1 in patients with baseline eosinophils ≥300 cells/μL
Annualized rate of severe exacerbation events during
the 24-week treatment periodc
DUPIXENT +
SOC
200 mg Q2Wa (n=631)
Placebo + SOC (n=317)
DUPIXENT + SOC
300 mg Q2Wb (n=633)
Placebo + SOC (n=321)
Pediatric patients (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; subjects with
baseline blood eosinophil
levels >1500 cells/μL were excluded
Subjects enrolled in QUEST were required to have, within 1 year of trial enrollment, treatment with systemic corticosteroids for worsening asthma at least once, or ED visit or hospitalization for worsening asthma
Subjects continued background asthma therapy throughout the duration of the studies, except in VENTURE in which OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained
Annualized rate of severe
exacerbation events during
the 52-week treatment period
in the overall population
Mean change from baseline to
Week 12 in FEV1 in the overall population
Annualized rate of severe exacerbation events during the 52‑week treatment period in patients with different baseline levels of eosinophils
Mean change from baseline to Week 52 in FEV1 in patients with different baseline levels of eosinophils
Responder rates in patient‑reported ACQ‑5 and AQLQ(S) scores
Mean change from baseline to Week 12 in FEV1 in patients with FeNO ≥25 ppb and in patients with IgE ≥30 IU/mL and baseline blood eosinophil levels ≥300 cells/μL
Annualized rate of severe exacerbation events during the
52‑week treatment period in patients with FeNO ≥25 ppb
and in patients with IgE
≥30 IU/mL and baseline blood eosinophil levels ≥300 cells/μL
DUPIXENT + SOC +
OCS
300 mg Q2Wb (n=103)
Placebo + SOC + OCS (n=107)
Subjects (≥12 years) with
asthma who required daily
OCS in addition to regular
use of standard of care of
high-dose ICS and a minimum of 1
and up to 2 additional controller
medications; subjects with
baseline blood eosinophil
levels >1500 cells/μL were excluded
Subjects continued background asthma therapy throughout the duration of the studies, except in VENTURE in which OCS dose was reduced every 4 weeks during the OCS reduction phase (Weeks 4-20), as long as asthma control was maintained
Percent reduction from baseline in OCS dose at Week 24, while maintaining asthma control, in the overall population
Annualized rate of severe exacerbation events during the 24-week treatment period
Mean change from baseline to Week 24 in FEV1
aWith 400 mg loading dose.
bWith 600 mg loading dose.
cResults were evaluated in the overall population and subgroups based on baseline blood eosinophil count.
ACQ-5, Asthma Control Questionnaire, 5-item version; AQLQ(S), Asthma Quality of Life Questionnaire, Standardized Version; ED, emergency department; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; ICS, inhaled corticosteroid; OCS, oral corticosteroid; Q2W, once every 2 weeks; SOC, standard of care.