STUDIED UP TO 1 YEAR IN NEARLY 3000 ASTHMA PATIENTS

Studied across multiple endpoints in 3 clinical trials1

TRIAL 1(N=776) 24 WEEKS
TRIAL 1(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
The total population of patients in Trials 1, 2, and 3 was unrestricted by minimum baseline blood eosinophil count
Subjects continued background asthma therapy throughout the duration of the studies, except in Trial 3 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

TRIAL 2(N=1902) 52 WEEKS
TRIAL 2(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
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; subjects with baseline blood eosinophil levels >1500 cells/μL (<1.3%) were excluded
The total population of patients in Trials 1, 2, and 3 was unrestricted by minimum baseline blood eosinophil count
Subjects continued background asthma therapy throughout the duration of the studies, except in Trial 3 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

Annualized rate of severe exacerbation events during the 52-week treatment period in subgroups of patients with ≥1, ≥2, ≥3, or ≥4 exacerbations in the prior year

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

TRIAL 3(N=210) 24 WEEKS
TRIAL 3(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 plus an additional controller medication; subjects with baseline blood eosinophil levels >1500 cells/μL (<1.3%) were excluded
The total population of patients in Trials 1, 2, and 3 was unrestricted by minimum baseline blood eosinophil count
Subjects continued background asthma therapy throughout the duration of the studies, except in Trial 3 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.

Q2W, once every 2 weeks.

Enrolled a diverse moderate-to-severe asthma patient population1

TRIAL 1(N=776) 24 WEEKS
TRIAL 1(N=776) 24 WEEKS
Mean age (SD), years
49 (13)
Female, %
White, %
63
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
(atopic dermatitis, %)
(nasal polyposis, %)
(allergic rhinitis, %)

73
(8)
(11)
(62)
Mean FeNO (±SD), ppb
39 (35)
Mean total lgE (±SD), IU/mL
435 (754)
Mean baseline
blood eosinophil
count (±SD), cells/µL
350 (430)
TRIAL 2(N=1902) 52 WEEKS
TRIAL 2(N=1902) 52 WEEKS
Mean age (SD), years
48 (15)
Female, %
White, %
63
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
(atopic dermatitis, %)
(nasal polyposis, %)
(allergic rhinitis, %)

78
(10)
(13)
(69)
Mean FeNO (±SD), ppb
35 (33)
Mean total lgE (±SD), IU/mL
432 (747)
Mean baseline
blood eosinophil
count (±SD), cells/µL
360 (370)
TRIAL 3(N=210) 24 WEEKS
TRIAL 3(N=210) 24 WEEKS
Mean age (SD), years
51 (13)
Female, %
White, %
61
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
(atopic dermatitis, %)
(nasal polyposis, %)
(allergic rhinitis, %)

72
(8)
(21)
(56)
Mean FeNO (±SD), ppb
38 (31)
Mean total lgE (±SD), IU/mL
431 (776)
Mean baseline
blood eosinophil
count (±SD), cells/µL
350 (310)

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Reference:

  1. DUPIXENT Prescribing Information.