Safety Data

Adverse reactions in the CRSwNP clinical trials1

Adverse reactions occurring in ≥1% of patients taking DUPIXENT Q2W + INCS and at a higher rate than placebo + INCS (24-week safety pool)

Trials 1 and 2
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.

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

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

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.

  • INCS, intranasal corticosteroids; Q2W, once every 2 weeks.
    Reference:
  1. DUPIXENT Prescribing Information.

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