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.
