STUDIED UP TO 1 YEAR IN NEARLY
3000 ASTHMA PATIENTS

View the study designs of 3 clinical trials that evaluated multiple endpoints.

Studied across multiple endpoints in 3 clinical trials1,2
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
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
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 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
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

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.

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.

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, %
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 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, %
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 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, %
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 lgE
(±SD), IU/mL
431 (776)
Mean baseline
blood
eosinophil
count (±SD),
cells/µL
350 (310)

References:

  1. DUPIXENT Prescribing Information.
  2. Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018;378(26):2475-2485.

Important Safety
Information and Indication

CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, anaphylaxis and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT in clinical trials. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.

Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult patients who participated in the asthma development program and cases of vasculitis consistent with EGPA have been reported with DUPIXENT in adult patients who participated in the asthma development program as well as in adult patients with co-morbid asthma in the chronic rhinosinusitis with nasal polyposis development program. A causal association between DUPIXENT and these conditions has not been established.

Acute Asthma Symptoms or Deteriorating Disease: Do not use DUPIXENT to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT.

Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) in patients with asthma are injection site reactions, oropharyngeal pain, and eosinophilia.

DRUG INTERACTIONS: Avoid use of live vaccines in patients treated with DUPIXENT.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy. Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or obtain information about the registry. Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus.
  • Lactation: There are no data on the presence of DUPIXENT in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.

Please see accompanying full Prescribing Information.


Indication

DUPIXENT is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.