DUPIXENT has been studied up to 1 year in nearly 3000 asthma patients1

Adverse reactions occurring in ≥1% of DUPIXENT + SOC patients and at a higher rate than placebo + SOC in DRI12544 and QUEST (6-month safety pool)1

DUPIXENT 200 mg
Q2W + SOC

n=779 n (%)

Injection site
reactionsa

111 (14)

Oropharyngeal
pain

13 (2)

Eosinophiliab

17 (2)

DUPIXENT 300 mg
Q2W + SOC

n=788
n (%)

Injection site
reactionsa

144 (18)

Oropharyngeal
pain

19 (2)

Eosinophiliab

16 (2)

PLACEBO + SOC
n=792
n (%)

Injection site
reactionsa

50 (6)

Oropharyngeal pain

7 (1)

Eosinophiliab

2 (<1)

  • The safety population (DRI12544 and QUEST) was 12-87 years of age, of which 63% were female and 82% were white. DUPIXENT 200 mg or 300 mg was administered subcutaneously Q2W, following an initial dose of 400 mg or 600 mg, respectively
  • In DRI12544 and QUEST, the proportion of subjects who discontinued treatment due to adverse events was 4% of the placebo + SOC group, 3% of the DUPIXENT 200 mg Q2W + SOC group, and 6% of the DUPIXENT 300 mg Q2W + SOC group

aInjection site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.

bNone met the criteria for serious eosinophilic conditions.

DUPIXENT demonstrated safety data in OCS-dependent asthma patients2

Adverse event occurring in ≥5% of patient in either group in VENTUREc

DUPIXENT 300 mg
Q2W + SOC

n=103 n (%)

Viral upper respiratory tract
infection

9 (9)

Bronchitis

7 (7)

Sinusitis

7 (7)

Influenza

3 (3)

Eosinophiliad

14 (14)

Injection site reactionee

9 (9)

≥1 measurement of blood eosinophil count >3000 cells/μL

13 (13)

PLACEBO + SOC n=107 n (%)

Adverse Event
Viral upper respiratory tract
infection

19 (18)

Bronchitis

6 (6)

Sinusitis

4 (4)

Influenza

6 (6)

Eosinophiliad

1 (1)

Injection site reactione

4 (4)

≥1 measurement of blood eosinophil count >3000 cells/μL

1 (1)

  • The safety population (VENTURE) included all patients who received at least 1 dose or a partial dose of DUPIXENT or placebo; data were analyzed according to the regimen received

aAdverse events in this category were reported according to preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA), version 20.0.

bThe adverse event of eosinophilia in this table is a combination of the preferred items of eosinophil count increase (in 7% of the patients in the DUPIXENT group vs no patients in the placebo group) and eosinophilia (7% vs 1%).

cInjection site reaction is a high-level term in MedDRA.

DUPIXENT demonstrated up to ~3 years of safety data in >2200 asthma patients

TEAEs occurring in ≥10% in any treatment group during the OLE period3

Patients enrolled
from DRI12544
DUPIXENT/DUPIXENT
n=421
n (%)
Adverse Reaction
Nasopharyngitis 109 (26)
Bronchitis 80 (19)
Upper respiratory
tract infection
60 (14)
Influenza 45 (11)
Pharyngitis 37 (9)
Headache 47 (11)
Injection site
erythema
55 (13)
Injection site
pruritus
16 (4)
Patients enrolled
from DRI12544
PLACEBO/DUPIXENT
n=111
n (%)
Adverse Reaction
Nasopharyngitis 27 (24)
Bronchitis 15 (14)
Upper respiratory
tract infection
18 (16)
Influenza 5 (5)
Pharyngitis 16 (14)
Headache 13 (12)
Injection site
erythema
26 (23)
Injection site
pruritus
12 (11)
Patients enrolled
from QUEST
DUPIXENT/DUPIXENT
n=1013
n (%)
Adverse Reaction
Nasopharyngitis 191 (19)
Bronchitis 118 (12)
Upper respiratory
tract infection
130 (13)
Influenza 69 (7)
Pharyngitis 59 (6)
Headache 74 (7)
Injection site
erythema
50 (5)
Injection site
pruritus
7 (1)
Patients enrolled
from QUEST
PLACEBO/DUPIXENT
n=517
n (%)
Adverse Reaction
Nasopharyngitis 99 (19)
Bronchitis 63 (12)
Upper respiratory
tract infection
65 (13)
Influenza 30 (6)
Pharyngitis 26 (5)
Headache 47 (9)
Injection site
erythema
35 (7)
Injection site
pruritus
15 (3)
Patients enrolled
from VENTURE
DUPIXENT/DUPIXENT
n=90
n (%)
Adverse Reaction
Nasopharyngitis 16 (18)
Bronchitis 14 (16)
Upper respiratory
tract infection
6 (7)
Influenza 7 (8)
Pharyngitis 4 (4)
Headache 5 (6)
Injection site
erythema
2 (2)
Injection site
pruritus
0
Patients enrolled
from VENTURE
PLACEBO/DUPIXENT
n=97
n (%)
Adverse Reaction
Nasopharyngitis 17 (18)
Bronchitis 9 (9)
Upper respiratory
tract infection
8 (8)
Influenza 9 (9)
Pharyngitis 1 (1)
Headache 4 (4)
Injection site
erythema
5 (5)
Injection site
pruritus
2 (2)
  • Other TEAEs occurred in ≥1% in any treatment group in TRAVERSE, including but not limited to oropharyngeal pain and eosinophilia4

Primary endpoint results: 86% of patients enrolled from DRI12544, 79% of patients enrolled from QUEST, and 77% of patients enrolled from VENTURE experienced at least one TEAE up to Week 96 of the OLE period.4

  • In DRI12544 and QUEST, the adverse reactions that occurred at a rate of at least 1% in subjects treated with DUPIXENT and at a higher rate than in their respective comparator groups were injection site reactions, oropharyngeal pain, and eosinophilia (6-month safety pool)1

Long-term safety
profile was consistent
with that seen in the
placebo-controlled
parent studies4

OLE, open-label extension; TEAE, treatment-emergent adverse event.

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