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.
|DUPIXENT 200 mg Q2W + SOC
|DUPIXENT 300 mg Q2W + SOC
|Placebo + SOC
|111 (14)||144 (18)||50 (6)|
|13 (2)||19 (2)||7 (1)|
|Eosinophiliab||17 (2)||16 (2)||2 (<1)|
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.
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.
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.
Avoid use of live vaccines in patients treated with DUPIXENT.
Reference: DUPIXENT Prescribing Information. October 2018.