An established safety profile

Demonstrated safety profile in the SINUS-24 and SINUS-52 trials

A total of 722 adult patients with CRSwNP were evaluated in two randomized, placebo-controlled, multicenter trials of 24 to 52 weeks duration (SINUS-24 and SINUS-52). The safety pool consisted of data from the first 24 weeks of treatment.

Adverse reactions occurring in ≥1% of the DUPIXENT® group in SINUS-24 and SINUS-52 and greater than placebo (24-week safety pool)

Adverse reaction

SINUS-24 and SINUS-52

 

DUPIXENT® (n=440)
n (%)

Placebo (n=282)
n (%)

Injection-site reactionsa

28 (6.4%)

12 (4.3%)

Conjunctivitisb

7 (1.6%)

2 (0.7%)

Arthralgia

14 (3.2%)

5 (1.8%)

Gastritis

7 (1.6%)

2 (0.7%)

Insomnia

6 (1.4%)

0 (0%)

Eosinophilia

5 (1.1%)

1 (0.4%)

Adapted from the Product Monograph.

a Injection-site reactions cluster includes injection-site reactions and swelling.
b Conjunctivitis cluster includes conjunctivitis, allergic conjunctivitis, bacterial
conjunctivitis, viral conjunctivitis, giant papillary conjunctivitis, eye irritation, and eye
inflammation.

In the safety pool, the proportion of subjects who discontinued treatment due to adverse events was 2.0% of the DUPIXENT® 300 mg Q2W group and 4.6% of the placebo group.

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MAT-CA-2300229E
Last updated: 06/2023

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