)
Injection site reactionsa
Injection site reactionsa
Adverse reactions occurring in ≥1% of patients taking DUPIXENT and at a
higher rate than placebo
SINUS-24 and SINUS-52
(24-week safety pool)
DUPIXENT 300 mg
Q2W + INCS n=440 n (%)
Q2W + INCS n=440 n (%)
DUPIXENT 300 mg
Q2W + INCS
n=440
n (%)
Q2W + INCS
n=440
n (%)
Injection site reactionsa
28 (6%)
Conjunctivitisb
7 (2%)
Arthralgia
14 (3%)
Gastritis
7 (2%)
Insomnia
6 (1%)
Eosinophilia
5 (1%)
Toothache
5 (1%)
Placebo + INCS n=282 n (%)
Placebo + INCS
n=282
n (%)
n=282
n (%)
Injection site reactionsa
12 (4%)
Conjunctivitisb
2 (1%)
Arthralgia
5 (2%)
Gastritis
2 (1%)
Insomnia
0 (<1%)
Eosinophilia
1 (<1%)
Toothache
1 (<1%)
aInjection site reactions cluster includes injection site reaction, pain, bruising, and swelling.
bConjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye inflammation.
The safety profile of DUPIXENT through Week 52 was generally consistent with the safety profile observed at Week 24.1
In subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared with 1% in the placebo group in the 24-week safety pool; these subjects recovered. There were no cases of keratitis reported in the CRSwNP development program.1
In SINUS-52 (52 weeks), the frequency of conjunctivitis was 3% in the DUPIXENT group compared with 1% in the placebo group; all of these subjects recovered.1
Rates of discontinuation
due to adverse events
were 2% with
DUPIXENT
and 5% with placebo1
INCS, intranasal corticosteroid; Q2W, once every 2 weeks.
Use of DUPIXENT for the CRSwNP indication in patients aged 12-17 years is supported by evidence from studies of DUPIXENT as add-on maintenance treatment in adults with inadequately controlled CRSwNP.1
Explore the
Study Designs
Dosage and
Administration
See the recommended dosing and administration options for patients on DUPIXENT.