DRI12544(N=776) 24 WEEKS
Randomized

DUPIXENT + SOC
200 mg Q2Wa (n=150)
Placebo + SOC (n=158)

DUPIXENT + SOC
300 mg Q2Wb (n=157)
Placebo + SOC (n=158)

Study population

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

The total population of patients in DRI12544, QUEST, and VENTURE was unrestricted by minimum baseline blood eosinophil count. In QUEST and VENTURE, 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.

Primary endpoint(s)

Mean change from baseline
to Week 12 in FEV1 in patients
with baseline eosinophils
≥300 cells/μL

Other endpoint(s)

Annualized rate of severe exacerbation events during
the 24-week treatment periodc

QUEST(N=1902) 52 WEEKS
Randomized

DUPIXENT + SOC
200 mg Q2Wa (n=631)
Placebo + SOC (n=317)

DUPIXENT + SOC
300 mg Q2Wb (n=633)
Placebo + SOC (n=321)

Study population

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

The total population of patients in DRI12544, QUEST, and VENTURE was unrestricted by minimum baseline blood eosinophil count. In QUEST and VENTURE, 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.

Primary endpoint(s)

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

Other endpoint(s)

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

VENTURE(N=210) 24 WEEKS
Randomized

DUPIXENT + SOC + OCS
300 mg Q2Wb (n=103)
Placebo + SOC + OCS (n=107)

Study population

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

The total population of patients in DRI12544, QUEST, and VENTURE was unrestricted by minimum baseline blood eosinophil count. In QUEST and VENTURE, 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.

Primary endpoint(s)

Percent reduction from baseline in OCS dose at
Week 24, while maintaining asthma control, in the overall population

Other endpoint(s)

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.

Baseline Demographics in DRI12544, QUEST, & VENTURE

 
DRI12544(N=776) 24 WEEKS
Mean age (SD),
years
49 (13)
Female, %
63
White, %

78
Mean duration
of asthma
(±SD), years
22 (15)
Never smoked,
%
77
Mean
exacerbations
in previous year
(±SD)
2.2 (2.1)
High-dose ICS
use, %
50
Pre-dose FEV1
at baseline
(±SD), L
1.84 (0.54)
Mean percent
predicted FEV1
at baseline
(±SD), %
61 (11)
Percent
reversibility
(±SD)
27 (15)
Atopic medical
history,
% overall
73
(atopic
dermatitis, %)

(8)
(nasal
polyposis, %)

(11)
(allergic
rhinitis, %)

(62)
Mean FeNO
(±SD), ppb
39 (35)
Mean total IgE
(±SD), IU/mL
435 (754)
Mean
baseline blood
eosinophil
count (±SD),
cells/µL
350 (430)
QUEST(N=1902) 52 WEEKS
Mean age (SD),
years
48 (15)
Female, %
63
White, %

83
Mean duration
of asthma
(±SD), years
21 (15)
Never smoked,
%
81
Mean
exacerbations
in previous year
(±SD)
2.1 (2.2)
High-dose ICS
use, %
52
Pre-dose FEV1
at baseline
(±SD), L
1.78 (0.60)
Mean percent
predicted FEV1
at baseline
(±SD), %
58 (14)
Percent
reversibility
(±SD)
26 (22)
Atopic medical
history, %
overall
78
(atopic
dermatitis, %)

(10)
(nasal
polyposis, %)

(13)
(allergic
rhinitis, %)

(69)
Mean FeNO
(±SD), ppb
35 (33)
Mean total IgE
(±SD), IU/mL
432 (747)
Mean baseline
blood
eosinophil
count (±SD),
cells/µL
360 (370)
VENTURE(N=210) 24 WEEKS
Mean age (SD),
years
51 (13)
Female, %
61
White, %

94
Mean duration
of asthma
(±SD), years
20 (14)
Never smoked,
%
81
Mean
exacerbations
in previous year
(±SD)
2.1 (2.2)
High-dose ICS
use, %
89
Pre-dose FEV1
at baseline
(±SD), L
1.58 (0.57)
Mean percent
predicted FEV1
at baseline
(±SD), %
52 (15)
Percent
reversibility
(±SD)
19 (23)
Atopic medical
history, %
overall
72
(atopic
dermatitis, %)

(8)
(nasal
polyposis, %)

(21)
(allergic rhinitis,
%)

(56)
Mean FeNO
(±SD), ppb
38 (31)
Mean total IgE
(±SD), IU/mL
431 (776)
Mean baseline
blood
eosinophil
count (±SD),
cells/µL
350 (310)

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