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 (%)
reactionsb
111 (14)
Oropharyngeal
pain
13 (2)
17 (2)
DUPIXENT 300 mg
Q2W + SOC
(n=788)
n (%)
reactionsa
144 (18)
Oropharyngeal
pain
19 (2)
16 (2)
PLACEBO + SOC
(n=792)
n (%)
reactionsb
50 (6)
Oropharyngeal pain
7 (1)
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.