DUPIXENT + SOC
200 mg Q2Wa (n=150)
Placebo + SOC (n=158)
DUPIXENT + SOC
300 mg Q2Wb (n=157)
Placebo + SOC (n=158)
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
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.
endpoint(s)
Mean change from baseline
to Week 12 in FEV1 in patients
with baseline eosinophils
≥300 cells/μL
endpoint(s)
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)
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
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.
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
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
DUPIXENT + SOC + OCS
300 mg Q2Wb (n=103)
Placebo + SOC + OCS (n=107)
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
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.
endpoint(s)
Percent reduction from baseline in OCS dose at
Week 24, while maintaining asthma control, in the overall population
endpoint(s)
Annualized rate of severe
exacerbation events during
the 24-week treatment period
Mean change from baseline
to Week 24 in FEV1
population
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
endpoint(s)
endpoint(s)
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
White, %
asthma (±SD), years
at baseline (±SD), L
FEV1 at baseline (±SD), %
(±SD)
history, % overall
(atopic dermatitis, %)
(nasal polyposis, %)
(allergic rhinitis, %)
IU/mL
blood eosinophil
count (±SD), cells/µL
years
78
of
asthma
(±SD), years
%
exacerbations
in
previous year
(±SD)
use, %
at baseline
(±SD), L
predicted
FEV1
at baseline
(±SD), %
reversibility
(±SD)
history,
% overall
dermatitis, %)
(8)
polyposis, %)
(11)
rhinitis, %)
(62)
(±SD), ppb
(±SD), IU/mL
baseline
blood
eosinophil
count (±SD),
cells/µL
years
83
of
asthma
(±SD), years
%
exacerbations
in
previous year
(±SD)
use, %
at baseline
(±SD), L
predicted
FEV1
at baseline
(±SD), %
reversibility
(±SD)
history, %
overall
dermatitis, %)
(10)
polyposis, %)
(13)
rhinitis, %)
(69)
(±SD), ppb
(±SD), IU/mL
blood
eosinophil
count (±SD),
cells/µL
years
94
of
asthma
(±SD), years
%
exacerbations
in
previous year
(±SD)
use, %
at baseline
(±SD), L
predicted
FEV1
at baseline
(±SD), %
reversibility
(±SD)
history, %
overall
dermatitis, %)
(8)
polyposis, %)
(21)
%)
(56)
(±SD), ppb
(±SD), IU/mL
blood
eosinophil
count (±SD),
cells/µL
ICS, inhaled corticosteroid
TRAVERSE enrolled over 2200 asthma patients, evaluated up to ~3 years6,7
TRAVERSE (N=2284), 48 to 96 weeks
| Randomized |
DUPIXENT + SOC
|
DUPIXENT + SOC
|
Subjects were initially enrolled for a 96-week treatment period; however, an amendment was issued to shorten the treatment period to |
| 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.
Select demographics and baseline characteristics7
Patients enrolled from DRI12544 and QUEST (n=2062): Mean duration of asthma: 21 years; never smoked: 80%; mean exacerbations in previous year: 2.18; 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; 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: 2.04; 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; mean baseline blood eosinophil count: 350 cells/μL.
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 comorbid/lung disease other than asthma, smoking, and lung disease that would impair lung function tests (eg, COPD).7
COPD, chronic obstructive pulmonary disease; LABA, long-acting beta agonist; LTRA, leukotriene receptor antagonist.