DUPIXENT is a fully human monoclonal antibody studied up to 1 year in
pediatric patients (6‑11 years) with uncontrolled asthma1
TEAEs occurring in ≥5% of patients IN THE DUPIXENT GROUP AND
GREATER THAN
PLACEBO
| Adverse Reaction |
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 adults and pediatric patients (12+ years) with moderate-to-severe asthma with the addition of helminth infections2
- 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 patients recovered with anti-helminth treatment without DUPIXENT treatment discontinuation2
- 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)1
Other attributes
DUPIXENT is not an immunosuppressant2
BD, bronchodilator; BL, baseline; EOS, eosinophils; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 second; IA, interviewer administered; ICS, inhaled corticosteroid; LSM, least squares mean; Q2W, once every 2 weeks; SCS, systemic corticosteroid; SOC, standard of care; TEAE, treatment-emergent adverse event.