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=134n (%)
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.