Adverse reactions occurring in ≥1% of DUPIXENT + SOC patients and at a higher rate than placebo + SOC in Trials 1 and 2 (6-month safety pool)1
|
Adverse Reaction |
DUPIXENT 200 mg Q2W + SOC n=779 n (%) |
DUPIXENT 300 mg Q2W + SOC n=788 n (%) |
Placebo + SOC n=792 n (%) |
|---|---|---|---|
|
Injection site reactionsa |
111 (14) | 144 (18) | 50 (6) |
|
Oropharyngeal pain |
13 (2) | 19 (2) | 7 (1) |
| Eosinophiliab | 17 (2) | 16 (2) | 2 (<1) |
- aInjection site reactions cluster includes erythema, edema, pruritus, pain, and inflammation.
- b None met the criteria for serious eosinophilic conditions.
- The safety population (Trials 1 and 2) was 12-87 years of age, of which 63% were female and 82% were white. DUPIXENT 200 mg or 300 mg was administered subcutaneously Q2W, following an initial dose of 400 mg or 600 mg, respectively
- In Trials 1 and 2, the proportion of subjects who discontinued treatment due to adverse events was 4% of the placebo + SOC group, 3% of the DUPIXENT 200 mg Q2W + SOC group, and 6% of the DUPIXENT 300 mg Q2W + SOC group
