Injection site reactionsb
DUPIXENT HAS A DEMONSTRATED
SAFETY PROFILE ACROSS ASTHMA
CLINICAL TRIALS
DUPIXENT has been studied up to 1 year in nearly 3000 asthma patients1,a
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)
DUPIXENT 200 mg
Q2W + SOC
(n=779) n (%)
Injection site
reactionsb
reactionsb
111 (14)
Oropharyngeal
pain
13 (2)
Eosinophiliac
17 (2)
DUPIXENT 300 mg
Q2W + SOC
(n=788)
n (%)
Injection site
reactionsb
reactionsb
144 (18)
Oropharyngeal
pain
19 (2)
Eosinophiliac
16 (2)
PLACEBO + SOC
(n=792)
n (%)
Injection site
reactionsb
reactionsb
50 (6)
Oropharyngeal pain
7 (1)
Eosinophiliac
2 (<1)
aThe asthma development program for patients aged 12 years and older included three randomized, double-blind, placebo-controlled, parallel-group, multicenter trials (DRI12544, QUEST, and VENTURE) of 24 to 52 weeks in treatment duration, which enrolled a total of 2888 subjects.
bInjection site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.
cNone met the criteria for serious eosinophilic conditions.
- 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
OLE, open-label extension; Q2W, once every 2 weeks; SOC, standard of care.
DUPIXENT demonstrated safety data in asthma patients requiring OCS2
Adverse events occurring in ≥5% of patients in either group in VENTUREd
DUPIXENT 300 mg
Q2W + SOC
(n=103) n (%)
Viral upper respiratory
tract infection
tract infection
9 (9)
Bronchitis
7 (7)
Sinusitis
7 (7)
Influenza
3 (3)
Eosinophiliae
14 (14)
Injection site reactionf
9 (9)
≥1 measurement of blood
eosinophil count >3000 cells/μL
eosinophil count >3000 cells/μL
13 (13)
PLACEBO + SOC (n=107) n (%)
ADVERSE EVENT
Viral upper respiratory
tract infection
tract infection
19 (18)
Bronchitis
6 (6)
Sinusitis
4 (4)
Influenza
6 (6)
Eosinophiliae
1 (1)
Injection site reactionf
4 (4)
≥1 measurement of blood
eosinophil count >3000 cells/μL
eosinophil count >3000 cells/μL
1 (1)
dAdverse events in this category were reported according to preferred terms in the Medical Dictionary for Regulatory Activities (MedDRA), version 20.0.
eThe 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%).
fInjection site reaction is a high-level term in MedDRA.
-
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
OCS, oral corticosteroid; OLE, open-label extension; Q2W, once every 2 weeks;
SOC, standard of care.
TRAVERSE demonstrated a long-term safety profile through ~3 years3,4
TEAEs occurring in ≥10% in any treatment group during the OLE period4
| Patients enrolled from DRI12544 |
|
| DUPIXENT/DUPIXENT (n=421) n (%) |
|
| TEAEs | |
| 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 (%) |
|
| TEAEs | |
| 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 (%) |
|
| TEAEs | |
| 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 (%) |
|
| TEAEs | |
| 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 (%) |
|
| TEAEs | |
| 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 (%) |
|
| TEAEs | |
| 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 eosinophilia3
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.3
- 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 studies3,4
OLE, open-label extension; TEAE, treatment-emergent adverse event.
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Dosage and Administration
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