Safety Data

Adverse reactions in the asthma population

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.

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)

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.
  • bNone met the criteria for serious eosinophilic conditions.

Specific adverse reactions in the asthma clinical trials

Hypersensitivity Reactions

Hypersensitivity reactions were reported in <1% of DUPIXENT-treated subjects. These included serum sickness reaction, serum sickness-like reaction, generalized urticaria, rash, erythema nodosum, and anaphylaxis.

Eosinophils

DUPIXENT-treated subjects had a greater initial increase from baseline in blood eosinophil count compared to subjects treated with placebo. In subjects with asthma, the mean and median increase in blood eosinophils from baseline to Week 4 were 130 and 10 cells/µL, respectively. The incidence of treatment-emergent eosinophilia (≥500 cells/μL) was similar in DUPIXENT and placebo groups. Treatment-emergent eosinophilia (≥5,000 cells/μL) was reported in <2% of DUPIXENT-treated patients and <0.5% in placebo-treated patients. Blood eosinophil counts declined to near baseline levels during study treatment.

Cardiovascular

In the 1-year placebo-controlled trial in subjects with asthma (Trial 2), cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) were reported in 1 (0.2%) of the DUPIXENT 200 mg Q2W group, 4 (0.6%) of the DUPIXENT 300 mg Q2W group, and 2 (0.3%) of the placebo group.

DRUG INTERACTIONS

Live Vaccines

Avoid use of live vaccines in patients treated with DUPIXENT.


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as add-on maintenance therapy
in moderate-to-severe asthma patients

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Reference: DUPIXENT Prescribing Information. October 2018.