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 (%)
DUPIXENT 300 mg 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 (%)
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

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