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STUDY DESIGNS IN PATIENTS 12+ YEARS

DUPIXENT Enrolled a Range of Patients with Moderate-to-Severe Asthma Across 3 Clinical Trials1-5

DUPIXENT ENROLLED A RANGE OF
PATIENTS WITH MODERATE-TO-SEVERE
ASTHMA ACROSS 3 CLINICAL TRIALS1-5

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, and VENTURE1

 
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), L
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), L
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), L
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)

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.

TRAVERSE enrolled more than 2200 asthma patients, evaluated through ~3 years2,6

TRAVERSE (N=2284), 48 to 96 weeks

Randomized

DUPIXENT + SOC
300 mg Q2W
48 weeksd (n=2282)

DUPIXENT + SOC
300 mg Q2W
96 weekse (n=1906)

Subjects were initially enrolled for a 96-week treatment period; however, an amendment was issued to shorten the treatment period to
48 weeks for all patients who enrolled following the amendment

Study population
  • Pediatric patients (12-17 years) and adults (≥18 years) with moderate-to-severe asthma who completed the treatment period in a previous DUPIXENT asthma clinical study (QUEST, VENTURE, EXPEDITION) or subjects with asthma who completed the treatment and follow-up periods in the previous DUPIXENT asthma study DRI12544
  • Subjects were on a background dose of medium- or high-dose ICS, as maintained during the parent study in which they participated, in combination with a second controller medication (and OCS for subjects from VENTURE)
  • Subjects requiring a third controller medication (eg, LABA, LTRA, methylxanthine) were allowed to enroll
Primary endpoint

Proportion of patients experiencing any TEAEs up to Week 96 of the OLE in populations from DRI12544, QUEST, EXPEDITION, and VENTURE

Select other endpoints
  • Number and annualized rate of severe exacerbation events
  • Forced expiratory volume in 1 second (FEV1) (L)
  • In the OCS-dependent population, percent reduction from baseline in OCS dose and proportions of patients achieving ≥50% reduction and completely tapering off OCS
Exclusion criteria

Subjects who developed a new medical condition, suffered a change in status of an established medical condition, developed a laboratory abnormality, or required a new treatment or medication during the screening period that would adversely affect participation in the study or require discontinuation of study medicationf

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.

d Total number of subjects enrolled and exposed to treatment in OLE.6

e Total number of subjects who continued to be exposed to treatment beyond 48 weeks.6

f Exclusion criteria of parent studies also applied, including pregnant/breastfeeding women, alcohol/drug abuse, clinically significant comorbidity/lung disease other than asthma, smoking, and lung disease that would impair lung function tests (eg, COPD).2
 

Select baseline characteristics2,6

Patients enrolled from DRI12544 and QUEST (n=2062): Mean duration of asthma: 21 years; never smoked: 80%; mean exacerbations in previous year: 2.2; high-dose ICS use: 55%; pre-dose FEV1 at baseline: 1.79 L; percent reversibility: 26%; atopic medical history, overall: 82%; atopic dermatitis: 10%; nasal polyposis: 13%; allergic rhinitis: 67%; mean FeNO: 36 ppb; mean total IgE: 438 IU/mL; and mean baseline blood eosinophil count: 360 cells/μL.

Patients enrolled from VENTURE (n=187): Mean duration of asthma: 21 years; never smoked: 82%; mean exacerbations in previous year: 2.0; high-dose ICS use: 91%; pre-dose FEV1 at baseline: 1.58 L; percent reversibility: 20%; atopic medical history, overall: 73%; atopic dermatitis: 8%; nasal polyposis: 20%; allergic rhinitis: 58%; mean FeNO: 37 ppb; mean total IgE: 451 IU/mL; and mean baseline blood eosinophil count: 350 cells/μL.  

COPD, chronic obstructive pulmonary disease; FeNO, fractional exhaled nitric oxide; ICS, inhaled corticosteroid; LABA, long-acting beta agonist; LTRA, leukotriene receptor antagonist; OCS, oral corticosteroid; OLE, open-label extension; Q2W, once every 2 weeks; SOC, standard of care; TEAE, treatment-emergent adverse event.

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