Indication DUPIXENT is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

ESTABLISHED SAFETY PROFILE UP TO 52 WEEKS1

Adverse reactions occurring in ≥1% of patients taking DUPIXENT 300 mg Q2W + INCS and at a higher rate than placebo + INCS

TRIALS 1 AND 2 (24-week safety pool)

Adverse
Reaction
DUPIXENT 300 mg Q2W + INCS
n=440
n (%)
Placebo + INCS
n=282
n (%)
Injection site
reactionsa
28 (6%) 12 (4%)
Conjunctivitisb 7 (2%) 2 (1%)
Arthralgia 14 (3%) 5 (2%)
Gastritis 7 (2%) 2 (1%)
Insomnia 6 (1%) 0 (<1%)
Eosinophilia 5 (1%) 1 (<1%)
Toothache 5 (1%) 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.

In the safety pool, the proportion of subjects who discontinued treatment due to adverse events was 2% in the DUPIXENT Q2W group and 5% in the PLACEBO group

The safety profile of DUPIXENT Q2W through Week 52 was generally consistent with the safety profile observed at Week 24.

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.

In Trial 2 (52 weeks), the frequency of conjunctivitis was 3% in the DUPIXENT group compared with 1% in the placebo group; all of these subjects recovered.

  • CRSwNP, chronic rhinosinusitis with nasal polyposis; INCS, intranasal corticosteroids; Q2W, once every 2 weeks.

Identify CRSwNP
patients appropriate
for DUPIXENT

View Patients

Reference:

  1. Dupixent Prescribing Information.