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%) |
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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.
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Reference:
- DUPIXENT Prescribing Information.
