Injection site reactionsa
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
reactionsa
111 (14)
Oropharyngeal
pain
13 (2)
Eosinophiliab
17 (2)
DUPIXENT 300 mg
Q2W + SOC
n=788
n (%)
Injection site
reactionsa
reactionsa
144 (18)
Oropharyngeal
pain
19 (2)
Eosinophiliab
16 (2)
PLACEBO + SOC
n=792
n (%)
Injection site
reactionsa
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 patients in either group in VENTUREc
DUPIXENT 300 mg
Q2W + SOC
n=103 n (%)
Viral upper respiratory tract
infection
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
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
cAdverse events in this category were reported according to preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA), version 20.0.
dThe 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%).
eInjection 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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Dosage and Administration
See the dosage and administration options for patients on DUPIXENT.