DUPIXENT is a fully human monoclonal antibody studied through 1 year in
children
aged 6-11 years with uncontrolled moderate-to-severe asthma1,2
TEAEs occurring in ≥5% of patients in the DUPIXENT group and greater than placebo
| TEAEs | DUPIXENT 100 mg/200 mg Q2W + SOC (n=271) n (%) |
PLACEBO + SOC (n=134) n (%) |
|---|---|---|
| Injection site erythema | 35 (13) | 13 (10) |
| Viral upper respiratory tract infection |
33 (12) | 13 (10) |
| Injection site edema | 28 (10) | 7 (5) |
| Injection site nodule | 17 (6) | 3 (2) |
| Eosinophilia | 16 (6) | 1 (1) |
- The safety profile of DUPIXENT through Week 52 was similar to the safety profile from studies in adult and pediatric subjects 12 years of age and older with moderate-to-severe asthma with the addition of helminth infections1
- Helminth infections were reported in 2.2% (6 subjects) in the DUPIXENT group and 0.7% (1 subject) in the placebo group. The majority of cases were enterobiasis, reported in 1.8% (5 subjects) in the DUPIXENT group and none in the placebo group. There was one case of ascariasis in the DUPIXENT group. All helminth infection cases were mild to moderate, and subjects recovered with anti-helminth treatment without DUPIXENT treatment discontinuation1
- The overall treatment discontinuation rate due to adverse events was similar between treatment groups (1.8% in the DUPIXENT group vs 1.5% in the placebo group)2
Q2W, once every 2 weeks; SOC, standard of care; TEAE, treatment-emergent adverse event.