DEMONSTRATED SAFETY ACROSS 3 CLINICAL TRIALS

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

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Reference:

  1. DUPIXENT Prescribing Information.